generic launch calendar...

Disclosures & Disclaimer

This report must be read with the disclosures and the analyst certifications in

the Disclosure appendix, and with the Disclaimer, which forms part of it.

Issuer of report: HSBC Securities and Capital Markets (India) Private Limited

View HSBC Global Research at:

https://www.research.hsbc.com

ANDA filings up 55% y-o-y: c536 ANDAs filed y-t-d Aug-16

First-time ANDA filings on Sensipar, Cialis & Belviq from Indian

generics. Levothyroxine inj, Mozobil & Delzicol other key filings

Generics lost cases on Multaq, Vimpat, Nucynta, pushing

opportunities further into future; wins on Benicar, Axiron, NuvaRing

The ANDA filing rate is up again: In 2016 y-t-d, ANDA filings, at 536, are up c55%

from 344 for the same period last year. ANDA approvals, at 409, are up c25% y-o-y

from 329. While the uptick is healthy, the ANDA backlog at the FDA still hovers at

around 4,000, of which almost a quarter is from India. Among Indian companies,

Aurobindo and Cadila lead in terms of the number of ANDAs pending approval,

followed closely by Sun Pharma and Lupin.

Pipeline visibility and complexity is highest in the case of Dr Reddy’s: Our

proprietary calendar carries on average 44% visibility on the ANDA pipeline of

generic companies. Of these known ANDAs filed, on average one-third is complex in

nature. Dr Reddy’s pipeline complexity is high at c74%, and has increased post the

acquisition of high-value ANDAs from Teva. Visibility in mid-caps – except Torrent

and Natco – is lower (~33%) due to a high share of Para III ANDAs. Overall

competitive intensity (no. of filers per product) is lowest in Natco’s portfolio and

highest for Alembic.

New ANDA filings: In this issue of our Generic Launch Calendar, we highlight new

filings in blockbuster products Sensipar and Cialis. Biocon and Cadila are stepping

up specialty filings, with filings on Copaxone and Alimta (Biocon), and Mozobil and

Delzicol (Cadila). Aurobindo continues a healthy pace of filings, with recent filings in

Sensipar, Cialis, Toviaz and Truvada, along with several other products. Lupin is

filing its ANDA on weight-loss drug Belviq and is likely FTF (first to file). Among the

litigations, we have seen generics lose on Multaq, Vimpat, Nucynta, Savella and

Fanapt, pushing these opportunities further into the future. Positive wins in the case

of Axiron and NuvaRing may benefit Lupin and Dr Reddy’s, respectively.

See the company tables later in this report for details on known ANDA filings.

10 October 2016

Girish Bakhru*, CFA

Analyst

HSBC Securities and Capital Markets (India) Private Limited

[email protected]

+91 22 22681638

Damayanti Kerai*

Analyst

HSBC Securities and Capital Markets (India) Private Limited

[email protected]

+91 22 33960692

* Employed by a non-US affiliate of HSBC Securities (USA) Inc, and is not registered/ qualified pursuant to FINRA regulations

Generic Launch Calendar EQUITIES PHARMACEUTICALS

India Issue XV – new filings, update on active litigations

EQUITIES PHARMACEUTICALS

10 October 2016

2

ANDA Pipeline Snapshot

Pending ANDA status of key generic players in the US

Source: Company data, HSBC

As shown in the chart below, most ANDA filings from Indian generics have high competition

intensity, which we define as the average number of filers per targeted product. Companies like

Alembic Pharma and Alkem have a competition intensity of more than nine, which indicates

their ANDA filings are highly competitive in nature. Natco Pharma’s competition intensity of 5.5

indicates filings on products where competition appears low currently. Most filings from Indian generics shows high competitive intensity

Source: HSBC, Company data *the lower the competition intensity, the better

Recent ANDA filings and approvals show steady trends

Source: FDA, HSBC

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10 October 2016

ANDA filings overview for key Indian generics

Company ANDA overview Value

Alembic Pharma ANDA pending FDA approval as of last update 35 Pipeline visibility 34.3% No. of known complex generics (CG) filed 1 Brand value of CG filed (A) 335 A as % of known Para-IV pipeline brand value 3.4% Alkem Lab ANDA pending FDA approval as of last update 50 Pipeline visibility 32.0% No. of known complex generics (CG) filed 1 Brand value of CG filed (A) 779 A as % of known Para-IV pipeline brand value 3.9% Aurobindo ANDA pending FDA approval as of last update 175 Pipeline visibility 21.7% No. of known complex generics (CG) filed 9 Brand value of CG filed (A) 6,349 A as % of known Para-IV pipeline brand value 23.3% Cadila Healthcare ANDA pending FDA approval as of last update 160 Pipeline visibility 25.0% No. of known complex generics (CG) filed 15 Brand value of CG filed (A) 4,796 A as % of known Para-IV pipeline brand value 22.9% Dr Reddy's Lab ANDA pending FDA approval as of last update 78 Pipeline visibility 51.3% No. of known complex generics (CG) filed 25 Brand value of CG filed (A) 18,335 A as % of known Para-IV pipeline brand value 73.9% Glenmark Pharma ANDA pending FDA approval as of last update 59 Pipeline visibility 40.7% No. of known complex generics (CG) filed 9 Brand value of CG filed (A) 5,278 A as % of known Para-IV pipeline brand value 33.6% Lupin ANDA pending FDA approval as of last update 149 Pipeline visibility 45.6% No. of known complex generics (CG) filed 30 Brand value of CG filed (A) 8,732 A as % of known Para-IV pipeline brand value 20.7% Natco Pharma ANDA pending FDA approval as of last update 22 Pipeline visibility 81.8% No. of known complex generics (CG) filed 13 Brand value of CG filed (A) 14,411 A as % of known Para-IV pipeline brand value 86.1% Sun Pharma ANDA pending FDA approval as of last update 150 Pipeline visibility 40.7% No. of known complex generics (CG) filed 27 Brand value of CG filed (A) 12,779 A as % of known Para-IV pipeline brand value 30.3% Torrent Pharma ANDA pending FDA approval as of last update 17 Pipeline visibility 64.7% No. of known complex generics (CG) filed 4 Brand value of CG filed (A) 6,871 A as % of known Para-IV pipeline brand value 39.9% Wockhardt ANDA pending FDA approval as of last update 50 Pipeline visibility 48.0% No. of known complex generics (CG) filed 10 Brand value of CG filed (A) 6,445 A as % of known Para-IV pipeline brand value 34.2%



10 October 2016

4

Snapshot of disclosed areas of pipeline for key generics

Aurobindo Pharma ANDA pipeline (n=175) Dr Reddy’s ANDA pipeline (n=78)

Source: Company data Source: Company data (OSD stands for oral solid dosages)

Lupin ANDA pipeline (n=149) Glenmark ANDA pipeline (n=59)

Source: Company data Source: Company data (IR=immediate release, MR=modified release)

Orals77%

Injectables+optha23%

OSD33%

Complex OSD19%

Injectables14%

Complex inj/sterile

21%

Softgel5%

Derm/ topical

8%

Orals64%

Derm/ topical16%

CS8%

OC6%

Ophthal4%

Inhalers1% Others

1%

IR49%

Derma22%

Hormones9%

MR5%

Oncology injectables

12%

Others3%

5


10 October 2016

Belviq (lorcaserin):

Lupin (LPC IN, CMP INR1,500, Buy) has filed P-IV ANDA for Arena/Eisai’s weight-loss drug,

Belviq (lorcaserin HCl). Lupin could be the first to file on this product, which has annual US

sales of cUSD100m.

Arena and Eisai are suing Lupin for infringement of ‘787,’422,’329,’158,’734,’379,’149,’970 and ‘213

patents covering Belviq. All these patents except ‘970 and ‘213 are expiring on Apr 10, 2023.

Delzicol (mesalamine):

Cadila Healthcare (CDH IN, CMP INR389.85, Hold) has strengthened its pipeline for ulcerative

colitis treatments with filed P-IV ANDA on Warner Chilcott’s (now Actavis) Delzicol (mesalamine

delayed release).

Cadila has challenged sole US patent ‘180 which has validity until April 2020. Teva is the first to

file on Delzicol, while Mylan is another known ANDA filer here.

Market size of the product is cUSD185m. We expect launch around 2020 when the patent expires.

Levothyroxine injection:

Dr Reddy’s (DRRD IN, CMP INR3,054.3, Reduce) filed P-IV ANDA on levothyroxine sodium

injection, which is indicated for treatment of thyroid hormone deficiency.

This product has annual US sales of cUSD95m; however there are only three known ANDA

filers so far, making it an attractive opportunity for Dr Reddy’s. Innovator Fresenius Kabi has

sued Dr Reddy’s for infringement of three patents, all of which have validity until 2032.

Fresenius recently won ANDA litigation with another ANDA filer Fera Pharma; hence we

assume this to be a late generic opportunity for Dr Reddy’s.

Sensipar (cinacalcet):

Aurobindo Pharma (ARBP IN, CMP INR855.8, Buy), Sun Pharma (SUNP IN, CMP INR751.2,

Hold), Dr Reddy’s (DRRD IN, CMP INR3,054.3, Reduce) & Cipla (CIPLA IN, CMP INR570.05,

Buy) have filed P-IV ANDAs on Amgen’s, Sensipar (cinacalcet) which is used to treat secondary

hyperparathyroidism (where parathyroid hormone level is elevated as a result of response to

low calcium in body which could be due to vitamin D deficiency or end stage renal diseases).

Key Indian ANDA filings

Multiple recent filings on big products like Sensipar and Cialis

Interesting filings over last few months include Copaxone from

Biocon, Levothyroxine injection from Dr Reddy’s

Dr Reddy’s and some others augment ANDA pipeline via acquisition of

ANDAs from Teva post its divestiture following acquisition of Actavis


10 October 2016

6

Sensipar is available as tablets in three doses – 30, 60 and 90mg and has annual US sales of

cUSD1.4bn as per MAT Jul’16 IMS Health data. Teva was the first to file (FTF) its ANDA in

2008, losing its litigation against innovator Amgen in 2011. The ruling against Teva blocked

generics until patent expiries of ‘146, ‘003 and ‘244 in Dec 2016. Another patent ‘068 claiming

drug substance is set to expire in March 2018 and therefore could be a road-block for generics.

Other ANDA filers include Micro Labs, Ajanta, Strides and Actavis.

The ODE (Orphan Drug Exclusivity) for Sensipar expires on Feb 25, 2018 and we expect Teva to

launch after that, one it has received final FDA approval. Other generics could gradually follow.

Cialis (tadalafil):

Multiple generics (Aurobindo Pharma, Sun Pharma, Cadila Healthcare, Actavis, Mylan and

Teva) have filed P-IV ANDA for Eli Lilly’s erectile dysfunction drug, Cialis (tadalafil).

ANDA filers are challenging ‘166 patent covering the drug which has US validity until Apr 26,

2020. We expect this generic opportunity to be competitive in nature.

This product has annual US sales of cUSD1.8bn as per MAT Jul’16 IMS Health data.

Copaxone (glatiramer acetate):

Biocon (BIOS IN, CMP INR944.3, Hold) has filed P-IV ANDA for Teva’s multiple sclerosis

treatment, Copaxone (40mg/ml) which has annual US sales of cUSD4bn. The filing is in

partnership with Apotex.

This filing indicates Biocon’s gradual progress towards increasing ANDA pipeline in the US. Dr

Reddy’s, Mylan/Natco and Sandoz/Momenta have shared FTF exclusivity on Copaxone 40mg/ml.

While it is difficult to predict the launch given there are multiple issues surrounding the

complexity of the molecule and IPR surrounding it, we believe this is a good filing from Biocon,

which is unlikely to see significant competition over next few years.

Alimta (Pemetrexed):

Biocon (BIOS IN, CMP INR944.3, Hold) has filed P-IV ANDA on Eli Lilly’s oncology injectable

drug, Alimta (annual US sales of cUSD1.2bn).

There are c12 ANDA filers on this product; nonetheless this filing indicates Biocon’s focus on

ramping up ANDAs especially in niche segments like oncology in the US.

A US District Court has upheld the validity of ‘209 patent until 2022; hence we assume any

generic launch post ‘209 expiry.

Truvada (emtricitabine and tenofovir disoproxil):

Aurobindo Pharma (ARBP IN, CMP INR855.8, Buy) has ramped up its pipeline for anti-HIV

drugs with a P-IV ANDA filing on Gilead’s Truvada (emtriciabine and tenoforvir disoproxil).

Truvada sales are cUSD2.8bn.

Aurobindo is challenging patents ‘245, ‘396, ‘264 and ‘397, of which ‘245 and ‘396 expire on

Sep 9, 2021 while ‘397 and ‘264 have validity until Jan 2024.

Teva (TEVA US, CMP USD45.52, Buy) is the first to file on Truvada and it had settled for

generic launch likely in 2017. Lupin has also settled its ANDA litigation on Truvada under

undisclosed terms.

Mylan and Hetero are other known P-IV ANDA filers on Truvada, which has annual US sales of

more than USD2.5bn. Aurobindo has tentative approval along with Teva, Mylan, Cipla, Strides

and Hetero for one strength.

7


10 October 2016

Toviaz (fesoterodine):

Pfizer has sued Aurobindo (ARBP IN, CMP INR855.8, Buy) for infringement of patents covering

overactive bladder treatment, Toviaz, through its ANDA filing. The patents in suit are ‘650, ‘980,

‘230, ‘772 and ‘478. These patents expire between May 2019 and July 2022 as per the FDA

Orange Book.

There are multiple ANDA filers for this product including Dr Reddy’s Lupin, Cadila, Hetero,

Alkem (ALKEM IN, CMP INR1658.75, Buy), Mylan, Wockhardt, Sandoz etc, hence we believe

generic market will be crowded upon generic launch post May 2019.

Toviaz has annual US sales of USD220m as per IMS Health MAT Jul’16 data.

Mozobil (plerixafor):

Cadila Healthcare (CDH IN, CMP INR389.85, Hold) has filed P-IV ANDA for Genzyme’s

oncology injectable drug, Mozobil (plerixafor). Genzyme is suing Cadila for infringement of US

patents ‘590 and ‘102 covering the product both of which have validity until Jul 22, 2023.

Teva and Dr Reddy’s could be first to file on this product which has annual US sales of

cUSD110m. Sandoz is another known ANDA filer.

Previously, Dr Reddy’s has appealed against a May 2016 District Court Ruling which has

enjoined it from commercially manufacturing generic Mozobil prior to the expiration date of ‘590

patent and held the validity of ‘590 patent.

Ferriprox (deferiprone):

Taro Pharma (Sun Pharma’s subsidiary) has filed ANDA for ApoPharma & Apotex’s iron

overload treatment caused by blood transfusion, Ferriprox.

ApoPharma & Apotex are suing Taro for infringement of sole patent ‘328 covering Ferriprox and

has validity until Jun 28, 2021. Taro is potentially first to file ANDA for this opportunity.

Mucinex (extended release guaifenesin or ERG):

Reckitt Benckiser (RB) has sued Sun Pharma (SUNP IN, CMP INR751.2, Hold) for infringement

of patents covering its OTC cough treatment Mucinex. RB alleges infringement of ‘252, ‘821 and

‘032 patents through Sun Pharma’s ANDA.

The entire Mucinex market is cUSD300m as per IMS Health but given it is an OTC, we believe

the market could be larger as it is difficult to capture the exact sales of OTC product. Actavis’

generic is available in 1.2mg strength while Perrigo had launched a generic in 600mg strength.

Dr Reddy’s, Aurobindo and Sun Pharma are other known ANDA filers for Mucinex.

Dr Reddy’s acquired Suboxone film & Nuvaring from Teva:

Dr Reddy’s (DRRD IN, CMP INR3,054.3, Reduce) had acquired 8 ANDAs from Teva for

consideration of USD350m including Suboxone (buprenorphine HCl and naloxone HCl)

sublingual film, indicated as maintenance treatment for opioid dependence. Suboxone has US

annual sales of more than USD1.5bn as per MAT Jul’16 IMS Health data.

Multiple generic filers have filed ANDAs for generic Suboxone-Mylan, Sandoz, Alvogen, Par

Pharma and BioDelivery/Quintiles. A recent ruling was in favour of Monosol Rx, which held the

‘514 patent valid and likely pushes launch to 2024.


10 October 2016

8

Dr Reddy’s has also acquired ANDA for Nuvaring (etonogestrel/ethinyl vaginal ring) which is a

combined hormonal birth control vaginal ring. This product has annual US sales of cUSD730m

as per MAT Jul’16 IMS Health data. Actavis (now part of Teva) is the first to file on Nuvaring.

Merck, innovator of the product, lost the district court case in Aug 2016, citing obviousness of

the patent ‘581. Merck has stated that it will appeal against the District Court ruling. The single

patent ‘581 covering the product will expire on Apr 8, 2018.

We believe this as a late FY18 or early FY19 opportunity for Dr Reddy’s, six-months after FTF

Actavis’s generic launch.

9


10 October 2016

Key MNC ANDA filings

Recent key ANDA filings by MNC generics

Molecule Brand Innovator Indication Annual US

sales (USDm) Who filed? Other filers

Insulin glargine Lantus Sanofi Aventis Diabetes 9,260 Merck/Samsung Eli Lilly Cyclosporine ophthalmic emulsion 0.05%

Restasis Allergan Dry eye 1,728 Twi Pharma Actavis, Akorn, Apotex, InnoPharma, Mylan, Teva, FamyCare

Everolimus Afinitor Novartis Cancer 818 Breckenridge Par Pharma and Roxane

Mirabegron Myrbetriq APGDI Overactive bladder 700 Actavis None Deferasirox Jadenu Novartis Chronic iron overload in

blood 307 Teva Actavis

Icatibant Firazyr Shire Acute attack of hereditary angioedema

186 InnoPharma Fresenius and Sandoz

Estradiol transdermal

Minivelle Noven Pharma Postmenopausal osteoporosis

154 Actavis, Alvogen

Mylan

Buprenorphine HCl and naloxone HCl

Zubsolv Orexo opioid dependence 128 Actavis None

Fluorouracil 0.5% cream

Carac Valeant Multiple actinic or solar keratoses

91 Allergan Sun Pharma, Spear Pharma

Ingenol mebutane Picato Leo Pharma Actinic keratosis 68 Perrigo Actavis Adapalene Differin Galderma Acne 65 Tolmar Actavis Itraconazole Sporanox Janssen Pharma Fungal infection 18 Xellia Apotex, Eon Labs,

Fera Pharma. Already generics with Accord, Amneal, Mylan and Sandoz generics in market

Alcaftadine ophthalmic solution 0.25%

Lastacaft Allergan Allergic conjuctivitis 17 Somerset Wilshire

Methylphenidate HCl ER chewable capsules

Aptensio XR Rhodes Pharma ADHD 9 Actavis None

Benzoyl alcohol lotion 5%

Ulesfia Shionogi Head lice in patients 6 months or older

8 Actavis None

Methylphenidate HCl ER chewable tablets

Tri Quillichew ER

Tris Pharm ADHD in children 3 Actavis None

Cabazitaxel Jevtana Sanofi Aventis Oncology Sandoz Accord, Actavis, Agila, Apotex, Belcher, Breckenridge, Dr Reddy's, Fresenius Kabi, Glenmark

Oxycodone myristate

Xtampza ER Purdue Pharma Pain Collegium Pharma

None

Amphetamine XR Adzenys XR ODT

Neos Therapeutics

Controlled substances Teva, Actavis None

Treprostinil Orenitram United Therapeutics

Pulmonary arterial hypertension

Actavis None



10 October 2016

10

Zydus Cadila prevails in Lialda ANDA litigation

The District Court of Delaware ruled that Zydus Cadila’s proposed generic of Lialda would not

infringe Shire’s patent ‘720 which has validity until Jun 8, 2020. Shire is likely to appeal against

this ruling. Cadila is yet to receive FDA tentative approval for its generic version of Lialda.

Previously the US Appeal Court of the Federal Circuit had reversed a District Court ruling that

Actavis’s proposed generic infringe ‘720 patent claims.

Generics prevail in Axiron ANDA litigation

The US District Court for the Southern District of Indiana has ruled in favour of generic filers

(Lupin, Perrigo, Actavis and Amneal) in Axiron (transdermal testosterone solution) ANDA

litigation versus innovator Eli Lilly. For Lupin’s ANDA, the court ruled that there was no direct

comparison of Lupin’s applicator and Eli Lilly’s and Lupin’s proposed generics will not infringe

any valid and enforceable patents covering Axiron. Therefore, Lupin is entitled to launch its

generic upon final FDA approval. A similar positive ruling was rendered to Perrigo and Actavis,

which have tentative approvals for their proposed generic of Axiron. Amneal, however generic

launch is prohibited until expiration of ‘861 patent on Feb 2027.

Eli Lilly has filed an appeal against this court ruling. Axiron has annual US sales of cUSD260m.

Apotex won Summary Judgement for Benicar:

The Northern District of Illinois granted Apotex a favourable ruling in Jan 2016 that its proposed

generic version of Benicar will not infringe innovator Daiichi Sankyo’s patent claims because

Daiichi had earlier disclaimed its patent right in an ANDA litigation with another filer Mylan.

Daiichi and Mylan appealed against this ruling; however in May 2016 the US Appeal Court

upheld the earlier District Court ruling.

As the first to file, Mylan is entitled to a 180-day generic exclusivity period when its generic sales

begin in October 2016 after the expiry of ‘599 patent. A favourable ruling for Apotex could curtail

the exclusivity period for Mylan. Currently there are 12 known ANDA filers (including Alembic,

Alkem, Aurobindo, Glenmark and Torrent Pharma) for this hypertension drug, which has annual

US sales of over USD1bn. We expect other generic filers to enter after the six months

exclusivity period for Mylan is over.

Other litigation updates

Recent cases with favourable rulings for generics – Axiron,

Lialda, Benicar

Recent cases with unfavourable rulings for generics – Vimpat,

Multaq, Fanapt, Nucynta, Savella

Recent settlements – many on Uloric, Teva on Byetta, Alkem

on Ampyra

11


10 October 2016

Generics lost Vimpat ANDA litigation:

The US District Court for the District of Delaware has confirmed validity of its US patent

RE38551 related to UCB’s anti-epileptic drug Vimpat (lacosamide). This favourable ruling for

UCB means ANDA filers cannot launch their generics until Mar 17, 2022 when ‘551 expires.

Following generics have filed ANDA for tablets form (annual US sales of USD850) – Intas

Pharma, Alembic Pharma, Amneal, Apotex, Aurobindo, Glenmark, Hetero, Mylan, Sandoz, Sun

Pharma, Teva and Cadila Healthcare. For the solution form of the drug (annual US sales of

USD55m), Amneal, Apotex, Glenmark and Sandoz have filed their ANDAs.

Intas Pharma has filed an appeal against this ruling; however we continue to consider Vimpat a

late generic opportunity unless generics win at the Appeals Court.

Generics lost Multaq ANDA litigation:

Generic companies including Actavis and Sandoz have appealed a recent decision of the US

District court of Delaware that claims 1-6, 8-13 and 16 of ‘167 patent are not invalid due to

obviousness or due to public use. It also said that ANDAs of respective generic companies

infringe ‘167 and ‘800 patent.

The ruling at district court essentially pushes the launch timelines to 2029 when ‘167 expires.

We have therefore pegged launch for most generic companies around that time unless generics

win at the appeals court.

There are ten known filers on the product including Glenmark, Sun Pharma, Lupin, Alkem,

Alembic and Unimark from Indian companies.

Roxane lost Fanapt ANDA litigation

Roxane which is first to file on Vanda Pharma’s schizophrenia drug, Fanapt (iloperidone) has lost its

ANDA litigation against the innovator. The US District Court of Delaware ruled that Roxane’s

proposed generic will infringe claims of US patents ‘198 and ‘610. The Court has enjoined Roxane

from commercially manufacturing generic until expiration of ‘610 patent on Nov 2, 2027.

There are five known ANDA filers for Fanapt (US annual sales of cUSD120m) – Roxane, Lupin,

Taro, Apotex and Inventia. Unfavourable ruling for Roxane means Fanapt will be a late

opportunity (and insignificant opportunity) for generics.

Generics lost Nucynta ANDA litigation

Depomed Inc has prevailed in an ANDA litigation involving its pain management drug, Nucynta

(tapentadol) including Nucynta ER and Nucynta oral solution. This favourable court ruling

prevents generics including Actavis, Alkem Lab and Roxane from launching their generic

version of products until 2025 when its ‘364 patent expires in the US.

There are more than 10 generic ANDA filers on Nucynta which has annual US sales of c230m

in the US.

Mylan lost Savella ANDA litigation

Mylan, potentially first to file (FTF) on fibromyalgia drug Savella (milnacipran), has lost its ANDA

litigation versus innovator Forest Lab. A Delaware federal judge has ruled that Mylan’s

proposed generic will infringe three patents – ‘911, ‘342 and ‘220 covering Savella.

Previously Forest Lab had settled its ANDA litigation against multiple generics including Glenmark

Pharma, Par Pharma, Apotex, Amneal, Hetero, Amneal etc under undisclosed settlement terms.

With Mylan losing its litigation, we believe generics for Savella will most likely come only in Nov 2021

after expiry of the ‘342 patent. Savella has annual US sales of USD150m.


10 October 2016

12

Generics settled Uloric ANDA litigation

Multiple generic filers including Indian filers like Dr Reddy’s, Lupin, Sun Pharma, Cadila

Healthcare have settled their ANDA litigation for Uloric (febuxostat, annual US sales of

cUSD480m) which is indicated for treatment hyperuricemia in gout patients.

The terms of settlement have not been disclosed and hence we assume generic launch in Jun

2019 upon expiry of the drug substance patent.

Alkem settled Ampyra ANDA litigation

Alkem Lab has entered an agreement with innovator Acorda Therapeutics to settle ANDA

litigation involving two patents covering multiple sclerosis drug, Ampyra (annual US sales of

USD235m). As per the settlement, Alkem can launch its generic in 2027 or earlier if some other

player launched its generic.

Previously Acorda had settled similar ANDA litigations with Aurobindo Pharma, Sun Pharma,

Actavis, Par Pharma and Accord Healthcare.

Teva settled Byetta ANDA litigation

Teva has entered an agreement with innovator Antares Pharma to settle ANDA litigation

involving two patents covering injectable drug for diabetes, Byetta (annual US sales of

USD300m). As per the settlement, first to file Teva can launch its generic on Oct 15, 2017 or

earlier under certain circumstances.

Amneal is the only other known P-IV ANDA filer on Byetta.

Celltrion’s Remicade biosimilar clears legal hurdle

In the legal battle between Janssen Biotech and Celltrion & Hospira over Remicade (infliximab)

biosimilar, the US District Court for the District of Massachusetts had ruled that US patent ‘471

covering the product is invalid due to Obviousness-Type Double Patenting.

Janssen plans to appeal the decision to the Court of Appeals for the Federal Circuit and as per

Janssen, a commercial launch of an infliximab biosimilar prior to the outcome of appeals would

be considered an at-risk launch.

In a bid to delay launch of Remicade (infliximab) biosimilar, Janssen Biotech had earlier sued

Celltrion alleging infringement of two patents (‘444 and ‘471) covering the product. The US FDA

had approved Celltrion’s biosimilar version of Remicade in April 2016.

This favourable ruling for Celltrion means biosimilar Remicade could launch in the US towards

end of 2016.

Sanofi files case against Merck/Samsung on Lantus biosimilar

Sanofi has sued Merck/Samsung on their biosimilar filing for Lantus (insulin glargine which has

annual US sales of cUSD7bn). This is second biosimilar application for Lantus after filing from

Eli Lilly/Boehringer. Merck/Samsung is challenging 10 patents covering the product.

Sanofi and Lilly/Boehringer earlier reached a settlement in a patent dispute around insulin

glargine. Under this settlement, Eli/Boehringer can launch their biosimilar version on Dec 16,

2016.

Biocon/Mylan, another front runner in biosimilar development is yet to file their biosimilar

application in the US.

13


10 October 2016

Aurobindo filed for Declaratory Judgment (DJ) for two patents on Prilosec OTC

Aurobindo has filed DJ against AstraZeneca seeking certainty that patents ‘616 and ‘810 are not

infringed by its proposed generic of Prilosec OTC (omeprazole magnesium) and the US FDA

can provide final approval to Aurobindo’s generic.

According to Aurobindo, AstraZeneca did not assert patent claims of ‘616 and ‘810 within 45

days of receipt of Aurobindo’s notice letter for P-IV ANDA filing.

This product indicated for stomach ulcers is already genericised with Perrigo’s and Dr Reddy’s

products available on the market.


10 October 2016

14

Generic Launch Calendar Note: (Company tables in alphabetical order)

(Bordered cell represents material generic opportunity while cell in pink highlight represents

settled opportunities)

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Alembic Pharma ANDA pipeline

Molecule Brand Indication Plain vanilla (PV) or complex generics (CG)? Annual sales (USDm) Who is FTF? No of ANDA filers Timeline

Olmesartan Benicar Hypertension PV 1,066 Mylan 12 FY18 Olmesartan HCTZ Benicar HCT Hypertension PV 800 Mylan 8 FY18 Desvenlafaxine succinate Pristiq MDD Depression PV 848 Multiple 13 Mar-17 Pregabalin Lyrica Anti-Convulsant PV 4,210 Multiple 8 Dec-18 Vardenafil ODT Staxyn Erectile dysfunction PV 10 Par Pharma 4 Apr-19 Fesoterodine fumarate Toviaz Overactive bladder PV 220 Multiple 13 May-19 Febuxostat Uloric Hyperuricemia in gout

patients PV 480 Mylan 12 FY20

Ticagrelor Brilinta Blood thinner PV 440 Multiple 12 Jul-21 Lacosamide Vimpat Seizures PV 750 Multiple 14 Mar-22

Vilazodone Viibryd Anti-depressant CG 335 Teva 5 Jun-22

Asenapine Saphris Bipolar disorder, schizophrenia

PV 300 5 Oct-26

Dronedarone Multaq Anti-arrythmia PV 470 Glenmark/Actavis 10 Apr-29 Total 9,929

Source: Company data, HSBC, Bloomberg

Alkem Lab ANDA pipeline


Rosuvastatin Crestor Anti-cholesterol PV 6,600 None 11 FY17

Rasagiline mesylate Azilect Early Parkinson's disease PV 340 6 Feb-17

Lanthanum carbonate Fosrenol Hyperphosphatemia PV 125 Natco, Teva, Mylan 7 FY18 Olmesartan Benicar Hypertension PV 1,066 Mylan 12 FY18 Olmesartan HCTZ Benicar HCT Hypertension PV 800 Mylan 8 FY18 Esomeprazole Nexium GERD PV 3,305 None 15 FY18 Aripiprazole Abilify Schizophrenia, bipolar

disorder, depression PV 3,314 Generic >20 FY18

Minocycline HCl Solodyn Acne PV 240 Multiple 11 Feb-18

Dabigatran Pradaxa Anti-coagulant PV 880 6 FY19

Fesoterodine fumarate Toviaz Overactive bladder PV 220 Multiple 13 May-19 Nebivolol Bystolic Hypertension PV 980 Multiple 6 Sep-21 Tapentadol Nucynta ER Pain management PV 200 4 Jun-25 Tapentadol Nucynta Pain management PV 236 11 2025 Sodium oxybate Xyrem Narcolepsy CG 779 Multiple 8 2025 Dalfampridine Ampyra Multiple sclerosis PV 350 Multiple 10 2027 Dronedarone Multaq Cardiac PV 470 Glenmark/Actavis 10 Apr-29 Total 19,905


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Aurobindo Pharma ANDA pipeline

Molecule Brand Indication Plain vanilla (PV) or complex generics (CG)? Annual sales (USDm) Who is FTF? Timeline

Esomeprazole Nexium GERD PV 3,305 None 15 FY17 Zoledronic acid Zometa Osteoporosis PV 50 Generic 15 FY17 Ritonavir Norvir HIV PV 340 Roxane 7 Dec-16 Lopinavir + Ritonavir Kaletra HIV PV 155 Multiple 6 Dec-16 Emtricitabine Emtriva HIV PV 25 Teva 5 FY17 Gatifloxacin Zymaxid Bacterial Conjunctivitis CG 35 Lupin 7 FY17 Paricalcitol Zemplar Metabolic Modifier PV 25 Generic 8 FY17

Abacavir + lamivudine Epzicom HIV PV 450 Teva 4 Feb-17

Olmesartan Benicar Hypertension PV 1,066 Mylan 12 FY18 Olmesartan HCTZ Benicar HCT Hypertension PV 800 Mylan 8 FY18 Atomoxetine hydrochloride Strattera ADHD PV 1,020 None 10 May-17 Armodafinil Nuvigil Narcolepsy PV 480 Mylan, Watson 10 Jun-17

Tenofovir Disporoxil Viread HIV PV 770 Teva 7 Jun-18

Emtricitabine + tenofovir Truvada HIV PV 2,821 Teva 6 Jun-18

Atazanavir Reyataz HIV PV 625 Teva 5 Jun-18

Minocycline Solodyn Acne PV 215 Impax, Teva, Sandoz, Mylan, Ranbaxy

11 Feb-18

Cinacalcet Sensipar Secondary hyperparathyroidism

CG 1,400 Teva 8 FY19

Ketorolac tromethamine Acular LS Ocular inflammation PV 2 Generic 4 Apr-18 Efavirenz Sustiva HIV PV 150 9 Jul-18 Carbamezapine XR Equetro Bipolar Disorder PV 10 Aurobindo 2 2018 Lansoprazole Prevacid SoluTab/ODT Peptic Ulcer/GERD CG 250 Teva 7 FY19 Bivalirudin Angiomax Anticoagulant CG 250 Teva, Fresenius 12 Dec-19 Palonosetron Aloxi Chemotherapy Induced

Nausea And Vomiting CG 505 Dr Reddy, Sandoz, Teva 19 2019

Tadalafil Cialis Erectile dysfunction, benign prostatic hyperplasia

PV 1,800 Multiple 6 Nov-20

Rivaroxaban Xarelto Anti-coagulant CG 3,260 Multiple 8 Dec-20 Moxifloxacin Vigamox Bacterial Conjunctivitis CG 292 None 6 Mar-20 Doripenem Doribax Injectable antibiotic CG 7 Sandoz 4 2021

Efavirenz+emtricibine+tenofovir Atripla HIV PV 2,690 Teva 7 Jan-19

Lacosamide Vimpat Seizures PV 850 Multiple 14 Mar-22 Prasugrel Effient Thrombotic cardiovascular

events PV 670 Multiple 17 2022

Saxagliptin Onglyza Type-2 Diabetes PV 580 Multiple 10 Jul-23 Saxagliptin+metformin Kombiglyze XR Type-2 Diabetes PV 305 Multiple 8 Jul-23 Pitavastatin Livalo Anti-cholesterol PV 239 Unknown 9 Feb 2024 Linagliptin Tradjenta Type 2 diabetes PV 1,125 Multiple 12 May-25 Linagliptin+metformin HCl Jentadueto Type 2 diabetes PV 175 Multiple 12 May-25 Dalfampridine Ampyra Multiple sclerosis CG 350 Multiple 10 2027 Tygecycline Tygacil Complicated skin and intra-

abdominal infections PV 85 Sandoz 7 Feb-29

Dextromethorphan +Guaifenesin Mucinex DM Cough relief PV 60 Actavis 6 Unknown Total 27,237


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Cadila Healthcare ANDA pipeline

Molecule Brand Indication Plain vanilla (PV) or complex generics (CG)? Annual Sales (USDm) Who is FTF? No of ANDA filers Timeline

Desloratadine Clarinex Asthma/Allergic Rhinitis PV 30 Generic Delayed Desloratadine Clarinex ODT Asthma/Allergic Rhinitis PV 10 Generic Delayed Irbesartan/hctz Avalide/Avapro Hypertension & CHF PV 15 generic 15 Delayed Aripiprazole Abilify Schizophrenia, Bipolar Disorder, Depression PV 3,314 Multiple >20 Delayed Aripiprazole Abilify ODT Schizophrenia, Bipolar Disorder, Depression PV 20 None 4 Delayed Esomeprazole Nexium GERD PV 3,305 None 15 Delayed Omeprazole+sodium bicarbonate

Zegerid GERD PV 402 Par 4 Delayed

Omeprazole+sodium bicarbonate

Zegerid OTC GERD PV 10 Par 4 Delayed

Calcium Acetate Phos Lo End stage renal disease CG 80 Generic 8 Delayed Levetiracetam ER Tablets Keppra XR Epilepsy PV 110 Generic >10 Delayed Azelastine Astelin/Astepro Allergic Rhinitis CG 90 Generic 7 Delayed Desvenlafaxine succinate Pristiq MDD Depression PV 848 Multiple 13 Mar-17

Lansoprazole Prevacid SoluTab/ODT

Peptic Ulcer/GERD CG 250 Teva 7 FY18

Phentermine HCl ODT Suprenza ODT Obesity reduction PV 1 unknown 1 Jul-16 Atomoxetine Strattera ADHD CG 1,020 None 10 May-17 Minocycline Solodyn Acne PV 215 Multiple 11 Feb-18 Palonosetron Aloxi Chemotherapy Induced Nausea & Vomiting CG 505 Dr Reddy, Sandoz, Teva 19 2019

Rivastigmine transdermal Exelon Patch Dementia related to Alzheimer's disease CG 278 Generic 9 Jan-19

Clofarabine Clolar Acute lymphoblastic leukemia CG 65 Abon Pharma 6 FY19 Fesoterodine fumarate Toviaz Overactive bladder PV 220 Multiple 13 May-19 Febuxostat Uloric Hyperuricemia in gout patients PV 480 Mylan 12 Jun-19

Dexmethylphenidate HCl ER Capsules

Focalin XR ADHD CG 721 Generic 8 Nov-19

Roflumilast Daliresp COPD CG 185 Mylan 10 Jan-20 Mesalamine delayed release Delzicol Ulcerative Colitis CG 185 Teva 3 Apr-20

Mesalamine Lialda Ulcerative Colitis CG 1,000 Cadila 6 Jun-20

Doxepin Silenor Sleep Disorder PV 35 Actavis 4 Jul-20 Methylphenidate HCl ER Capsules

Metadate CD ADHD CG 65 Teva 4 Oct-20

Tadalafil Cialis Erectile dysfunction, benign prostatic hyperplasia PV 1,800 Multiple 6 Nov-20

Lacosamide Vimpat Seizures PV 850 Multiple 14 Mar-22 Prasugrel Effient Thrombotic cardiovascular events PV 670 Multiple 17 2022 Plerixafor Mozobil Oncology CG 112 Teva/Dr Reddy's? 4 2023 Pitavastatin Livalo Anti-cholesterol PV 239 Unknown 9 Feb 2024 Gabapentin ER Gralise Pain PV 140 Multiple 5 Jan-24 Linagliptin Tradjenta Type 2 diabetes PV 1,125 Multiple 12 May-25 Linagliptin+metformin HCl Jentadueto Type 2 diabetes PV 175 Multiple 12 May-25 Memantine Namenda XR Alzheimer's Disease PV 1,226 Multiple 14 Nov-25 Topiramate Trokendi XR Seizures CG 200 Actavis 3 2025 Tapentadol Nucynta Pain management PV 236 11 2025 Diclofenac sodium soln Pennsaid Arthritis PV 700 Apotex, Lupin 10 2029 Methylphenidate HCl ER Ritalin LA Attention deficit disorder (ADD) and narcolepsy CG 40 Generic 5 Unknown Total 20,972


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Dr Reddy’s ANDA pipeline (1/2)

Molecule Brand Indication Plain vanilla (PV) or complex generic (CG)? Annual sales (USDm) Who is FTF? No of ANDA filers Timeline

Propofol Diprivan Anaesthesia CG 288 Generic 6 Delayed

Desvenlafaxine succinate Pristiq MDD Depression PV 848 Multiple 13 Mar-17

Imatinib Gleevec Chronic Myeloid Leukemia CG 2,300 Sun Pharma 10 Mar-17

Glatiramer Acetate Copaxone Multiple Sclerosis CG 4,000 Dr Reddy's, Natco/Mylan, Sandoz/Momenta

5 FY18/19

Bortezomib Velcade Oncology CG 660 Teva 14 FY18

Ethinyl estradiol/ Etonogestrel

NuvaRing Vaginal Contraceptive CG 730 Teva 2 Apr-18

Clofarabine Clolar Acute lymphoblastic leukemia CG 65 Abon Pharma 6 Jul-18 Palonosetron Aloxi Chemotherapy induced

nausea and vomiting CG 505 Dr Reddy, Sandoz, Teva 19 Sep-18

Ixabepilone Ixempra Oncology (Breast Cancer) CG 35 Unknown 1 Nov-18

Daptomycin Cubicin MRSA (infections) CG 1,175 Teva 8 2018

Rivastigmine (transdermal) Exelon Patch Alzheimer's Disease CG 457 Generic 9 Jan-19 Cinacalcet Sensipar Secondary

hyperparathyroidism CG 1,400 Teva 8 FY19

Fesoterodine fumarate Toviaz Overactive bladder PV 220 Multiple 13 May-19 Febuxostat Uloric Hyperuricemia in gout

patients PV 480 Mylan 12 Jun-19

Bivalirudin Angiomax Anticoagulant CG 250 Teva, Fresenius 12 Dec-19

Dexlansoprazole Dexilant Acid Reflux PV 1,280 Handa Pharma, Impax? 7 Jun-20

Ciprofloxacin + Dexamethasone

Ciprodex Otitis Media CG 455 3 Aug-20

Lubiprostone Amitiza Chronic indiopathic constipation, irritable bowel syndrome with constipation

CG 460 Par 2 Jul-21

Prasugrel Effient Thrombotic cardiovascular events

PV 630 Multiple 17 2022

Pemetrexed disodium Alimta Oncology CG 1,170 Teva 12 Nov-22 Plerixafor Mozobil Oncology CG 112 Teva/Dr Reddy's? 4 2023

Buprenorphine HCl and naloxone HCl

Suboxone sublingual film Maintenance treatment of opiod dependence

CG 1,530 7 Apr-24


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Dr Reddy’s ANDA pipeline (2/2)

Molecule Brand Indication Plain vanilla (PV) or complex generic (CG)? Annual sales (USDm) Who is FTF? No of ANDA filers Timeline

Naproxen + Sumatriptan Treximet Migraine PV 120 Par 5 2025 Sapropterin Dihydrochloride Kuvan PKU (phenylketonuria) CG 60 Dr Reddy's 2 2025 Linagliptin Tradjenta Type 2 diabetes PV 1,125 Multiple 12 2025 Linagliptin+metformin HCl Jentadueto Type 2 diabetes PV 175 Multiple 12 2025 Zolpidem Tartarate Intermezzo Insomnia CG 10 Actavis 6 Feb-25 Pralatrexate Folotyn Relapsed or refractory

peripheral T-cell lymphoma CG 25 Dr Reddy's, Teva, Sandoz,

Fresenius Kabi 4 May-25

Cabazitaxel Jevtana kit Oncology CG 156 Multiple 10 2025 Transdermal testosterone gel Androgel 1.62% Hormone replacement

therapy CG 1,120 Perrigo 7 2026

Abiraterone acetate Zytiga Oncology CG 1,100 Multiple 12 2027 Bendamustine Treanda CLL, lymphomas PV 517 Multiple 21 2026 Icosapent ethyl Vascepa Lower triglyceride CG 177 6 2030

Levothyroxine sodium injectable

Levothyroxine sodium injectable

Thyroid hormone deficiency treatment

CG 95 3 2032

Doxycycline Oracea Rosacea PV 340 Mylan 6 Unknown Rosiglitazone Avandia Diabetes PV 1 Teva 2 Unknown Esomeprazole magnesium + naproxen

Vimovo Osteoarthritic Pain PV 583 Dr. Reddy's 5 Unknown

Guaifenesin extended release

Mucinex D Cough relief PV 60 Generic 6 Unknown

Omeprazole delayed release (OTC)

Stomach ulcer PV 3 Unknown

Esomeprazole magnesium trihydrate

Nexium 24hr (OTC) GERD PV 112 Perrigo, Paddock 4 Unknown

Total 24,826


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Glenmark Pharma ANDA pipeline


Desloratadine Clarinex Asthma/Allergic Rhinitis PV 30 Generic 9 Delayed

Ezetimibe Zetia High Cholesterol PV 2,540 Glenmark 4 Dec-16

Atomoxetine hydrochloride Strattera ADHD PV 1,020 None 10 May-17

Colesevelam Welchol High Cholesterol CG 750 Impax tabs/ Lupin susp. 4 FY18

Bortezomib Velcade Oncology CG 660 Teva 14 FY18 Olmesartan Benicar Hypertension PV 1,066 Mylan 12 FY18 Olmesartan HCTZ Benicar HCT Hypertension PV 800 Mylan 8 FY18

Mycophenolate sodium Myfortic Immunosuppressant CG 272 Generic 5 Feb-18

Azelaic Acid Finacea Rosacea PV 133 None 1 Nov-18

Fulvestrant injection Faslodex Oncology CG 400 6 Jul-21

Nebivolol Bystolic Hypertension PV 975 Multiple 6 Sep-21 Milnacipran HCl Savella Fibromyalgia PV 150 Multiple 10 2021 Lacosamide Vimpat Seizures PV 933 Multiple 14 Mar-22 Rufinamide Banzel Epilepsy PV 222 Multiple 6 May-22 Pemetrexed disodium Alimta Oncology CG 1,170 Teva 12 Nov-22 Prasugrel Effient Thrombotic cardiovascular

events PV 670 Multiple 17 2022

Saxagliptin Onglyza Type-2 Diabetes PV 580 Multiple 10 Jul-23 Saxagliptin+metformin Kombiglyze XR Type-2 Diabetes PV 305 Multiple 8 Jul-23 Cabazitaxel Jevtana kit Oncology CG 136 9 2025 Bendamustine Treanda CLL, lymphomas PV 517 Multiple 21 2026 Adapalene+benzoyl peroxide Epiduo gel Acne Vulgaris CG 310 Actavis (Watson) 7 Jul-27 Abiraterone acetate Zytiga Oncology CG 1,100 Multiple 12 2027 Estradiol, norethindrone Lo Loestrin Fe Oral Contraceptive CG 480 Lupin 4 Feb-29 Dronedarone Multaq Anti-arrythmia PV 470 Glenmark/Actavis 10 Apr-29 Total 15,689


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Lupin ANDA pipeline (1/2)


Esomeprazole Nexium GERD PV 3,305 None 15 Delayed Tolterodine Detrol LA OAB PV 278 Impax, Teva 7 Delayed Aripiprazole Abilify Schizophrenia, Bipolar

Disorder, Depression PV 3,314 Generic >20 Delayed

Desvenlafaxine succinate Pristiq MDD Depression PV 848 Multiple 13 Mar-17 Emtricitabine Emtriva HIV PV 25 Teva 5 FY17 Darunavir Prezista HIV PV 1,050 Lupin, Mylan 5 FY17 Armodafinil Nuvigil Narcolepsy PV 480 Mylan, Watson 10 Jan-17

Abacavir + lamivudine Epzicom HIV PV 450 Generic 4 Feb-17

Ethinyl estradiol, norethindrone Minastrin 24 Fe Oral Contraceptive CG 350 Lupin 3 Mar-17

Carvedilol CR Coreg CR Hypertension, Heart Attack, Heart Failure

CG 235 Sun Pharma 4 FY17

Sevelamer hydrochloride Renagel Chronic Kidney Disease PV 210 Lupin 5 FY18

Sevelamer carbonate Renvela Chronic Kidney Disease PV 1,955 Impax, Lupin on susp. 6 FY18

Bromfenac soln Prolensa Ocular inflammation CG 130 Lupin 6 FY18

Lanthanum Carbonate Fosrenol Chronic Kidney Disease CG 125 Natco, Teva, Mylan 7 FY18

Colesevelam Welchol High Cholesterol CG 750 Impax tabs/ Lupin susp. 4 FY18

Mesalamine Asacol 400mg Ulcerative Colitis CG 0 Roxane 3 FY18 Quetiapine Seroquel XR Schizophrenia/Bipolar

Disorder PV 1,350 Par Pharma 12 May-17

Lapatinib ditosylate Tykerb Breast Cancer CG 65 Natco Pharma 1 Jun-17 Paroxetine HCl Paxil CR Antidepressant PV 127 3 Sep-17 Oseltamivir Tamiflu Influenza PV 570 Natco 2 Jan-18 Minocycline Solodyn Acne PV 470 Multiple 11 Feb-18

Tenofovir Disporoxil Viread HIV PV 770 Teva 7 Jun-18

Emtricitabine + tenofovir Truvada HIV PV 3,080 Teva 6 Jun-18

Lurasidone Latuda Bipolar depression PV 2,098 Multiple 6 Jul-18

Ascorbic acid, polyethylene glycol Moviprep Bowel cleansing before colonoscopy

CG 65 Novel Lab 2 Sep-18

Lansoprazole ODT Prevacid Solutab Acid reflux drug PV 250 Teva 7 Nov-18 Pregabalin Lyrica Anti-Convulsant PV 4,210 Multiple 8 Dec-18

Efavirenz+emtricibine+tenofovir Atripla HIV PV 2,690 Teva 7 Jan-19

Ranolazine Ranexa Chronic Angina Pectoris CG 774 Lupin 1 May-19

Fesoterodine fumarate Toviaz Overactive bladder PV 220 Multiple 13 May-19 Febuxostat Uloric Hyperuricemia in gout

patients PV 480 Mylan 12 Jun-19

Palonosetron Aloxi Chemotherapy Induced Nausea And Vomiting

CG 505 Dr Reddy, Sandoz, Teva 19 2019

Moxifloxacin Vigamox Bacterial Conjunctivitis CG 290 None 6 Mar-20 Moxifloxacin Moxeza Bacterial Conjunctivitis CG 25 Lupin 2 Mar-20 Budesonide Uceris Colitis CG 200 Par Pharma 5 Jun-20


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Lupin ANDA pipeline (2/2)


Mesalamine Lialda Ulcerative Colitis CG 1,000 Cadila 6 2020

Drospirnone + estradiol + levomefolate

Safyral Oral Contraceptive CG 25 Actavis 2 2020

Milnacipran HCl Savella Fibromyalgia PV 150 Multiple 10 2021 Rufinamide Banzel Epilepsy PV 222 Multiple 6 May-22

Mesalamine ER Apriso Ulcerative Colitis CG 215 Lupin 2 Oct'22

Prasugrel Effient Thrombotic cardiovascular events

PV 630 Multiple 17 2022

Drospirenone ethinyl estradiol and levomefolate calcium

Beyaz Oral Contraceptive CG 130 Actavis 2 Jul-22

Magnesium sulfate, Potassium sulfate, Sodium sulfate

Suprep bowel kit Bowel cleansing before colonoscopy

CG 180 Novel Lab 6 Mar-23

Lorcaserin Hcl Belviq Weight-loss PV 90 Lupin 1 Apr-23 Testosterone (transdermal) Axiron Testosterone Treatment CG 250 Actavis, Perrigo 4 2023 Pitavastatin Livalo Anti-cholesterol PV 239 Unknown 9 Feb 2024 Calcium acetate solution Phoslyra End Stage Renal Disease CG 2 Lupin, Par 3 2025 Memantine Namenda XR Alzheimer's Disease PV 1,226 Teva, Sun, Wockhardt 14 Nov-25 Sodium Oxybate soln Xyrem Narcolepsy CG 779 Roxane 7 Dec-25 Tapentadol Nucynta Pain management PV 236 11 2025 Estrogen, progestin, ethinyl estradiol

Quartette Oral Contraceptive CG 11 Lupin 3 2025

Estradiol valerate + dienogest Natazia Oral Contraceptive CG 20 Lupin 2 2026 Transdermal testosterone gel Androgel 1.62% Hormone replacement

therapy CG 1,120 Perrigo 7 2026

Iloperidone Fanapt Schizophrenia PV 134 Roxane 5 Nov-27 Bimatoprost Lumigan Glaucoma CG 675 Sandoz, Lupin 5 2027 Adapalene+benzoyl peroxide Epiduo gel Acne Vulgaris CG 310 Actavis (Watson) 7 Jul-27 Sodium phosphate Osmoprep Bowel cleansing before

colonoscopy CG 11 1 Jun-28

Estradiol, norethindrone Lo Loestrin Fe Oral Contraceptive CG 480 Lupin 4 Feb-29 Dronedarone Multaq Anti-arrythmia PV 470 Glenmark/Actavis 10 Apr-29 Diclofenac sodium soln Pennsaid 2% Arthritis PV 700 Actavis 10 2029 Diclofenac Zorvolex Mild to moderate acute pain

and osteoarthritis pain PV 40 Lupin 41 Apr-30

Clozapine Fazaclo Anti-psychotic PV 83 Generic 3 Unknown Glycerol Phenylbutyrate Ravicti Inborn urea cycle disorder PV Par 2 Unknown Doxycycline Oracea Rosacea PV 340 Mylan 6 Unknown Esomeprazole magnesium+naproxen

Vimovo Osteoarthritic Pain PV 583 Dr. Reddy's 5 Unknown

Ketorolac tromethamine Acular LS NSAID CG 1 Generic 4 Unknown Drospirenone + Estradiol Angeliq Oral Contraceptive CG 9 Shared Unknown Esomeprazole magnesium trihydrate

Nexium 24hr (OTC) GERD PV 112 Perrigo, Paddock 4 Unknown

Total 42,217


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Natco Pharma ANDA pipeline

Molecule Brand Indication Plain vanilla (PV) or complex generics (CG)? Annual sales (USDm) Who is FTF? No. of filers Timeline

Budesonide capsule 3mg Entocort EC Crohn's disease CG 395 Generics 4 FY17

Armodafinil Nuvigil Narcolepsy PV 480 Mylan, Watson 10 Jan-17

Oseltamivir Tamiflu Influenza PV 1,067 Natco 2 Jun-17

Glatiramer Copaxone Multiple Sclerosis CG 4,200 Mylan/Natco & Sandoz/Momenta on 20mg/ml. Dr Reddy's, Mylan/Natco & Sandoz/Momenta on 40mg/ml strength

5 FY17/18

Bosentan Tracleer Oncology CG 40 Apotex, Roxane 3 FY17 Amoxicillin+clarithromycin+lansoprazole

Prevpac Anti-infective PV 52 Generic 4 FY17

Laptinib Tykerb Breast Cancer CG 65 Natco (sole FTF) 1 Jun-17

Lanthanum carbonate Fosrenol Chronic Kidney Disease CG 125 Natco, Teva, Mylan 7 FY18

Imatinib Gleevec Chronic Myeloid Leukemia CG 2,300 Sun Pharma 10 FY18

Fingolimod Gilenya Multiple Sclerosis CG 1,996 7 Feb-19

Lenalidomide Revlimid Multiple myeloma CG 4,500 Natco 1 Mar-22

Everolimus Zortress Organ rejection CG 100 Roxane 3 Mar-20 Cabazitaxel Jevtana Oncology CG 136 Multiple 9 2025 Bendamustine Treanda CLL, lymphomas PV 730 Multiple 21 2026 Sorafenib Nexavar Oncology CG 51 Mylan 1 Dec-27 Lansoprazole OTC Prevacid OTC Acid reflux PV Generic 4 Unknown

Doxorubicin Doxil Ovarian cancer CG 203 Generic 2 Unknown

Azacitidine Vidaza Oncology CG 300 Generic 5 Unknown Total 16,740


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Sun Pharma ANDA pipeline (1/2)


Zoledronic acid Reclast Osteoporosis PV 65 Generic 12 Delayed Drospirenone + Ethinyl estradiol

Yaz Contraception CG 76 Generic 7 Delayed

Paricalcitol Zemplar Metabolic Modifier PV 57 Generic 8 Delayed Irbesartan/hctz Avalide/Avapro Hypertension & CHF PV 15 Generic 15 Delayed Pioglitazone + metformin Actoplus met Type-2 Diabetes PV 65 Mylan 6 Delayed Valganciclovir Valcyte Cytomegalovirus Infections PV 376 Generic 7 Delayed Esomeprazole Nexium GERD PV 3,305 None 15 Delayed Carvedilol CR Coreg CR Hypertension, Heart Attack,

Heart Failure CG 235 Sun Pharma (URL) 4 Delayed

Estradiol, norgestimate OrthoTricyclen Lo Oral Contraceptive CG 450 Generic 10 Delayed Adefovir Hepsera HIV PV 20 Sigmapharm 2 Delayed Aripiprazole Abilify Schizophrenia, Bipolar

Disorder, Depression PV 3,314 Multiple >20 Delayed

Aspirin + Dypridamole Aggrenox Stroke PV 267 Generic 6 Delayed Pantoprazole Protonix IV GERD PV 95 Generic 7 Delayed Sirolimus Rapamune Immuno-suppressant CG 210 Generic 4 Delayed Atomoxetine Strattera ADHD CG 1,020 None 10 May-17 Minocycline Solodyn Acne PV 215 Impax, Teva, Sandoz, Mylan,

Ranbaxy 11 Feb-18

Bortezomib Velcade Oncology CG 660 Teva 14 FY18

Ganirelix acetate Antagon Infertility CG 54 Sun Pharma 1 Jun-18

Lurasidone Latuda Bipolar depression PV 2,098 Multiple 6 Jul-18 Lansoprazole ODT Prevacid SoluTab/ODT Peptic Ulcer/Gerd CG 250 Teva 7 Nov-18 Clindamycin + benzoyl peroxide

Acanya Acne CG 75 Actavis 4 Dec-18

Pregabalin Lyrica Anti-Convulsant PV 4,210 Multiple 8 Dec-18 Clofarabine Clolar Acute lymphoblastic leukemia CG 65 Abon Pharma 6 Feb-19

Bowel cleansing formulation Moviprep Bowel cleansing before colonoscopy

CG 65 Novel Lab 2 Mar-19

Cinacalcet Sensipar Secondary hyperparathyroidism

CG 1,400 Teva 8 FY19

Imiquimod Zyclara Actinic Keratosis CG 63 Actavis 2 Jun-19

Febuxostat Uloric Hyperuricemia in gout patients

PV 480 Mylan 12 Jun-19

Dexmethylphenidate HCl ER Capsules

Focalin XR ADHD CG 721 Generic 8 Nov-19

Bivalirudin Angiomax Anticoagulant CG 250 Teva, Fresenius 12 Dec-19


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Sun Pharma ANDA pipeline (2/2)


Tadalafil Cialis Erectile dysfunction, benign prostatic hyperplasia

PV 1,800 Multiple 6 Nov-20

Fluorouracil 0.5% cream Carac Multiple actinic or solar kertoses CG 90 3 Jun-21 Milnacipran HCl Savella Fibromyalgia PV 150 Multiple 10 2021 Lacosamide Vimpat Seizures PV 850 Multiple 14 Mar-22

Sitagliptin phosphate Januvia Type-2 diabetes PV 4,560 Multiple 6 Jul-22

Estradiol vaginal tablets Vagifem Atrophic vaginitis due to menopause CG 420 Amneal 3 Sep-22

Pemetrexed disodium Alimta Oncology CG 1,170 Teva 12 Nov-22 Prasugrel Effient Thrombotic cardiovascular events PV 670 Multiple 17 2022 Bowel cleansing formulation Superp bowel kit Bowel cleansing before colonoscopy CG 180 Novel Lab 6 Mar-23 Saxagliptin Onglyza Type-2 Diabetes PV 580 Multiple 10 Jul-23 Saxagliptin+metformin Kombiglyze XR Type-2 Diabetes PV 305 Multiple 8 Jul-23 Oxycodone Oxaydo Pain CG 5 Mar-25 Oxycodone Oxycontin Moderate To Severe Pain CG 2,200 Ranbaxy, Teva, Endo 13 Mar-25 Linagliptin Tradjenta Type 2 diabetes PV 1,125 Multiple 12 May-25 Linagliptin+metformin HCl Jentadueto Type 2 diabetes PV 175 Multiple 12 May-25 Risedronate (Delayed release)

Atelvia Osteoporosis PV 40 Generic 4 Jul-25

Memantine Namenda XR Alzheimer's Disease PV 1,226 Teva, Sun, Wockhardt 14 Nov-25 Sodium Oxybate soln Xyrem Narcolepsy CG 779 Roxane 7 Dec-25 Naproxen + sumatriptan Treximet Migraine PV 120 Par 5 2025

Sitagliptin phosphate + metformin

Janumet Type-2 diabetes PV 1,360 Multiple 6 Apr-26

Dextromethorphan + qunidine Nuedexta Pseudobulbar affect (PBA) CG 256 Par, Watson 6 Jul-26 Bendamustine Treanda CLL, lymphomas PV 517 Multiple 21 2026 Dalfampridine Ampyra Multiple sclerosis CG 350 Multiple 10 2027 Abiraterone acetate Zytiga Oncology CG 1,100 Multiple 12 2027 Adapalene+benzoyl peroxide Epiduo gel Acne Vulgaris CG 310 Actavis (Watson) 7 Jul-27 Iloperidone Fanapt Schizophrenia PV 134 Roxane 5 Nov-27 Dronedarone Multaq Anti-arrythmia PV 470 Glenmark/Actavis 10 Apr-29 Oxymorphone Opana ER CRF Pain CG 325 Multiple 8 Nov-29 Diclofenac sodium soln Pennsaid 2% Arthritis PV 700 Apotex, Lupin 10 2029 Guaifenesin extended release

Mucinex D Cough relief PV 60 Generic 6 Unknown

Deferiprone Ferriprox Treatment for iron overload in thalassaemia major patients

PV Taro? 1 Unknown

Omeprazole delayed release (OTC)

Stomach ulcer PV 3 Unknown

Total 42,203


26

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IES

P

HA

RM

AC

EU

TIC

AL

S

10

Octo

be

r 20

16

Torrent Pharma ANDA pipeline


Fluvoxamine Luvox CR Social Anxiety Disorder PV 45 Generic 3 Delayed Rosuvastatin Crestor High Cholesterol PV 6,039 None 11 FY17 Darifenacin Enablex Overactive Bladder PV 82 Multiple 6 FY17 Quetiapine Seroquel XR Schizophrenia/Bipolar

Disorder PV 1,350 Par Pharma + Handa 12 May-17

Olmesartan Benicar Hypertension PV 1,066 Mylan 12 FY18 Olmesartan HCTZ Benicar HCT Hypertension PV 800 Mylan 8 FY18 Sildenafil Viagra Erectile dysfunction CG 1,430 No FTF 9 May-18

Fingolimod Gilenya Multiple Sclerosis CG 1,996 7 Feb-19

Roflumilast Daliresp COPD CG 185 Mylan 10 Jan-20 Rivaroxaban Xarelto Anti-coagulant CG 3,260 Multiple 8 Dec-20 Nebivolol Bystolic Hypertension PV 980 Multiple 6 Sep-21 Total 17,233


27

EQ

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IES

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RM

AC

EU

TIC

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16

Wockhardt ANDA pipeline

Molecule Brand Indication Plain vanilla (PV) or complex generics (CG)? Annual sales (USDm) Who is FTF? Timeline

Fenofibrate TriCor High Cholesterol PV 120 Generic 11 Delayed Duloxetine Cymbalta MDD Depression PV 180 Generic >20 Delayed Zoledronic acid Reclast Osteoporosis PV 50 Generic 12 Delayed Eszopiclone Lunesta Insomnia PV 40 Generic 10 Delayed Olopatadine 0.1% Patanol Eye allergy CG 120 Generic 4 Delayed Diclofenac potassium sol Cambia Migraine PV 55 Wockhardt 3 May-17 Aripiprazole Abilify Schizophrenia, Bipolar

Disorder, Depression PV 3,314 Generic >20 FY18

Imatinib Gleevec Chronic Myeloid Leukemia CG 2,300 Sun Pharma 10 FY18 Bortezomib Velcade Oncology CG 660 Teva 14 FY18 Bupropion Forfivo XL MDD Depression CG 20 Wockhardt 1 Jan-18 Lansoprazole Prevacid SoluTab/ODT Peptic Ulcer/Gerd PV 250 Teva 7 FY19 Pregabalin Lyrica Anti-Convulsant PV 4,210 Multiple 8 Dec-18 Fesoterodine fumarate Toviaz Overactive bladder PV 220 Multiple 13 May-19 Acetaminophen injectable Ofirmev Pain management CG 280 7 Dec-20 Saxagliptin Onglyza Type-2 Diabetes PV 580 Multiple 10 Jul-23 Saxagliptin+metformin Kombiglyze XR Type-2 Diabetes PV 305 Multiple 8 Jul-23 Olopatadine 0.2% Pataday Eye allergy CG 370 Teva 5 May-24 Memantine Namenda XR Alzheimer's Disease PV 1,226 Teva, Sun, Wockhardt 14 Nov-25 Sodium Oxybate soln Xyrem Narcolepsy CG 779 Roxane 8 Dec-25 Tapentadol Nucynta Pain management PV 236 11 2025 Dextromethorphan + Quinidine

Nuedexta Pseudobulbar affect (PBA) CG 256 Par, Watson 6 Jul-26

Bendamustine Treanda CLL, lymphomas PV 517 Multiple 21 2026 Abiraterone acetate Zytiga Oncology CG 1,100 Multiple 12 2027

Travoprost Travatan Z Glaucoma CG 560 Par 8 Oct-29

Total 18,826



10 October 2016

28

Disclosure appendix

Analyst Certification

The following analyst(s), economist(s), and/or strategist(s) who is(are) primarily responsible for this report, certifies(y) that the

opinion(s) on the subject security(ies) or issuer(s) and/or any other views or forecasts expressed herein accurately reflect their

personal view(s) and that no part of their compensation was, is or will be directly or indirectly related to the specific

recommendation(s) or views contained in this research report:Girish Bakhru, CFA and Damayanti Kerai

Important disclosures

Equities: Stock ratings and basis for financial analysis

HSBC believes an investor's decision to buy or sell a stock should depend on individual circumstances such as the investor's

existing holdings, risk tolerance and other considerations and that investors utilise various disciplines and investment horizons

when making investment decisions. Ratings should not be used or relied on in isolation as investment advice. Different

securities firms use a variety of ratings terms as well as different rating systems to describe their recommendations and

therefore investors should carefully read the definitions of the ratings used in each research report. Further, investors should

carefully read the entire research report and not infer its contents from the rating because research reports contain more

complete information concerning the analysts' views and the basis for the rating.

From 23rd March 2015 HSBC has assigned ratings on the following basis:

The target price is based on the analyst’s assessment of the stock’s actual current value, although we expect it to take six to 12

months for the market price to reflect this. When the target price is more than 20% above the current share price, the stock will

be classified as a Buy; when it is between 5% and 20% above the current share price, the stock may be classified as a Buy or a

Hold; when it is between 5% below and 5% above the current share price, the stock will be classified as a Hold; when it is

between 5% and 20% below the current share price, the stock may be classified as a Hold or a Reduce; and when it is more

than 20% below the current share price, the stock will be classified as a Reduce.

Our ratings are re-calibrated against these bands at the time of any 'material change' (initiation or resumption of coverage,

change in target price or estimates).

Upside/Downside is the percentage difference between the target price and the share price.

Prior to this date, HSBC’s rating structure was applied on the following basis:

For each stock we set a required rate of return calculated from the cost of equity for that stock’s domestic or, as appropria te,

regional market established by our strategy team. The target price for a stock represented the value the analyst expected the

stock to reach over our performance horizon. The performance horizon was 12 months. For a stock to be classified as

Overweight, the potential return, which equals the percentage difference between the current share price and the target price,

including the forecast dividend yield when indicated, had to exceed the required return by at least 5 percentage points over the

succeeding 12 months (or 10 percentage points for a stock classified as Volatile*). For a stock to be classified as Underweight,

the stock was expected to underperform its required return by at least 5 percentage points over the succeeding 12 months (or

10 percentage points for a stock classified as Volatile*). Stocks between these bands were classified as Neutral.

*A stock was classified as volatile if its historical volatility had exceeded 40%, if the stock had been listed for less than 12

months (unless it was in an industry or sector where volatility is low) or if the analyst expected significant volatility. However,

stocks which we did not consider volatile may in fact also have behaved in such a way. Historical volatility was defined as the

past month's average of the daily 365-day moving average volatilities. In order to avoid misleadingly frequent changes in rating,

however, volatility had to move 2.5 percentage points past the 40% benchmark in either direction for a stock's status to change.

29


10 October 2016

Rating distribution for long-term investment opportunities

As of 10 October 2016, the distribution of all independent ratings published by HSBC is as follows:

For the purposes of the distribution above the following mapping structure is used during the transition from the previous to

current rating models: under our previous model, Overweight = Buy, Neutral = Hold and Underweight = Sell; under our current

model Buy = Buy, Hold = Hold and Reduce = Sell. For rating definitions under both models, please see “Stock ratings and basis

for financial analysis” above.

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To view a list of all the independent fundamental ratings disseminated by HSBC during the preceding 12-month period, please

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Analysts, economists, and strategists are paid in part by reference to the profitability of HSBC which includes investment

banking, sales & trading, and principal trading revenues.

Whether, or in what time frame, an update of this analysis will be published is not determined in advance.

Economic sanctions imposed by the EU and OFAC prohibit transacting or dealing in new debt or equity of Russian SSI entities.

This report does not constitute advice in relation to any securities issued by Russian SSI entities on or after July 16 2014 and as

such, this report should not be construed as an inducement to transact in any sanctioned securities.

For disclosures in respect of any company mentioned in this report, please see the most recently published report on that

company available at www.hsbcnet.com/research. In order to find out more about the proprietary models used to produce this

report, please contact the authoring analyst.

Additional disclosures

1. This report is dated as at 10 October 2016.

2. All market data included in this report are dated as at close 07 October 2016, unless a different date and/or a specific time

of day is indicated in the report.

3. HSBC has procedures in place to identify and manage any potential conflicts of interest that arise in connection with its

Research business. HSBC's analysts and its other staff who are involved in the preparation and dissemination of Research

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Production & distribution disclosures

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2. In order to see when this report was first disseminated please see the disclosure page available at

https://www.research.hsbc.com/R/34/qjJdlw7

Buy 43% ( 25% of these provided with Investment Banking Services )

Hold 41% ( 26% of these provided with Investment Banking Services )

Sell 16% ( 19% of these provided with Investment Banking Services )


10 October 2016

30

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[530518]

Europe

Dr Stephen McGarry +44 20 7991 3164 [email protected]

Julie Mead +44 20 7991 9643 [email protected]

Jan Keppeler, CFA +49 211 910 2446 [email protected]

Richard Latz +49 211 910 1074 [email protected]

Asia Girish Bakhru, CFA +91 22 2268 1638 [email protected]

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Zhijie Zhao +852 2996 6591 [email protected]

Yumeng Wang +852 2996 6586 [email protected]

LatAm Ricardo N Rezende, CFA +1 212 525 5901 [email protected]

Global Healthcare Research Team

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