patent expiry

Drugs Off-Patent Reports

Drugs Off-Patent Reports 2 Over USD $100 million

PHARMACEUTICALDRUG DEVELOPMENT

D R U G SD R U G SoFF-Patents

REPORTSREPORTS

2000ISSN 0793 694X

L O C U M P U B L I S H I N G H O U S E



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Copyright © 1995 - 2001, Handbook of Pharmaceutical Generic Development.Text Copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.Illustration copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.Locum International Publishing House PO Box 874, 50 Gilad Street Kochav Yair 44864Israel. - All right reserved.

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L o c u m I n t e r n a t i o n a lISSN 0793 694X

L o c u m I n t e r n a t i o n a l P u b l i s h e r s

A IAGIM DrugDevelopmentPublication

DRUGSDRUGSoverover

$100m

Copyright ©1995-2001 by LocumPublishing House Inc. All RightsReserved.

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A L o c u m H o u s e P u b l i c a t i o n


Drugs Off-Patent Reports 5 Over USD$ 100 million

P H A R M A C E U T I C A L

DRUG DEVELOPMENT

DRUGSOFF-Patents

ReportsReports

2000ISSN 0793 694X

[This report consists of 24 pages]



D r u g s Off-PatentR e p o r t s

HOW THE CODES WORK

Generic Drug Products generally have two codes namely a PATENT USE Code andan EXCLUSIVITY code. These two patent protection codes usually expire at quitedifferent times.

Generally when the New Chemical Entity (NCE) expires the Generic equivalent ofthe Brand Leader may be manufactured after appropriate ANDA approval. Howeverseveral exclusivity's may be in force (i.e. the 'N' or 'D' codes) such as 'New Dosage','New Salt' or 'New Strength' etc. The 'D codes' apply to New Dosing Schedules andare much less common.

Naturally the package insert of an on-market generic drug will not show a newindication still protected by an I-code exclusivity. Thus I-code exclusivity's may run forseveral years while the generic is being marketed. The same applies for the 'N' and'D' codes as well.

Drug OFFDrug OFFor ONor ONPatentPatent

GenericName

PatentHolder

Marketer

PatentExpiry

+

ExclusivityExpiry

Patent&

Exclusivity

EarliestGeneric

199920001

Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)

More thanone namemay exist

U-Codesapply here

All othercodes

apply here

DD/MM/YY InMillionsof US

Dollars

The Codes:-NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for 'Therapeutic Use' stillunder Patent Protection.

I = Code for New SpecificIndication under ExclusivityProtection.

D = New Dosing Schedule

U-Codes

Apply to thisPatent # andthis Patent

date.Several

Patents mayexist for each

Generic

The following codesapply to this

exclusivity date:-All

I-codesD-codes

NCENDFNENCNSNP

ODE

This Date is theearliest generic

marketing date andmay apply to eitherthe patent expiry ora Exclusivity Expiry.

NOTEIn many cases an

OFF-Patent Genericmay have anON-Patent

I Code; U Code or Ncode




I S S N 0 7 9 3 6 9 4 X

Electronic < Reports on DiskReports on Web :

e-- ReportsÏ20v01Ò

Drugs Over $100 million US DollarsYear of Expiration - 1997

Drug OFFDrug OFFPatentPatent

GenericName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001

Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)

Bactroban Mupirocin SKB 1/31/95

06/08/92

1/31/97

1/31/97

-

-

Expired 180204

Lodine Etodolac AHP/WyeAyerst

2/28/95

6/1/91

2/28/97

2/28/97

NCE Expired 372411

Timoptic Timololmaleate

Merck &Co

3/25/97

9/26/95

-

3/25/97

Expired 245

270

Trental Pentoxi-

fylline

Hoechst-

Roussel

6/5/90

8/30/85

4/3/97

4/3/97

Expired 314346

Zovirax Acyclovir BW 4/22/97

8/27/95

-

4/22/97

1.71 Expired 354394

Glucotrol

XL

Glipizide Pfizer/

Pratt

4/26/97

N/A 4/26/97

NDF Expired 153170

Zantac Ranitidine Glaxo

Wellcome

12/5/95

7/25/97

-

7/25/97

D-21,

I-116

Expired 26882934

Taxol Paclitaxel B-M-S 12/29/97

N/A

-

12/29/97

I - 77,

NP,NCE

Expired 513572

Toradol Ketorolac

trometh-

amine

Roche/

Syntex

5/16/95

7/14/96

5/16/97

5/16/97

NR Expired 295331.

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for 'Therapeutic Use' stillunder Patent Protection

I = Code for specific Indicationunder Exclusivity Protection


1Includes Generics




I S S N 0 7 9 3 6 9 4 X

Year of Expiration - 1998


GenericName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001

Trade Generic NAME Patent # DATEmm/dd/YY

CODES DATE USD$(Mil)

RETIN A TretinoinGel

Ortho/J&J 1/02/984-247-547

1/27/98 - Expired 101121

Paraplatin Carboplatin B-M-S 2-20-96

6/8/92

8/28/98

8/28/98

- Expired 255285

Lescol Fluvastatin SandozNovartis

12/31/98

NA

-

12/31/98

D-31

NCE

Expired 349386

DiltazemHCl

Tiazac Forest/Biovail

6/25/135-529-791

9/11/98 NS Expired 120166

OxycodoneHCl

Oxycontin PerdueFrederick

2/05/08 12/12/985-266-331

NDF Expired 300343

FluvastitinSodium

Lescol Norvaris 10/11/115-354-772

12/31/98 NCE Expired 247276.


GenericName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection






I S S N 0 7 9 3 6 9 4 X



GenericName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


Primaxin Imipenencilastatin Na

Merck &Co

2/18/994-194-047

M/D/YY - Expired 139154

DiclofenacNa

Voltarin XR Novartis P 3/8/99 -NDF

Expired 132158

EtodolacCR

Londine XL AHPWyeth

10/30/074-966-768

10\25\99 Expired 150181

NIZEROL Ketaconazole JNJJanson 6/15/99

I - 88 Expired 155186

Zoladex Goserelinacetate

Zeneca 4/22/99 I - 88 Expired 138162

Daypro Oxaprozin SearleMonsanto

P10/29/99

NCE Expired 252360.

Norcuron Vecuroniumbromide

Organon 8/20/99 -8/20/99

- Expired 150152

VancenaseAQ

Beclomethasone

dipropionate

Schering-Plough

P -6/26/99 NP

Expired 285315

VancenasePlain

Beclomethasone

dipropionate

Schering-Plough

12/21/994-364-923

M/D/YY-

Expired 6582

Vanceril Beclomethasone

dipropionate

Schering-Plough

Key

12/21/994-364-923

M/D/YY-

Expired 190211

Unasyn Ampicillin Sod/sulbactam

Sod.

Pfizer 11/18/974-234-579


Versed Inj. Midazolam Roche/Syntex

11/18/99 12/20/9912/20/99

- Expired 310353

NicodermCQ

Nicotine SKB -8/2/99

NP Expired 160177

Azmacort Triamcinaloneacetonide

RPR -18,117

-10/30/99

D-7 Expired 255273

Luvox Fluvoxaminemaleate

U.S.Phillips

P12/05/99

NCE Expired 179201

OmnipaqueIohexal Sanofi

12/26/994-250-133


Lamisilcream

TerbinafineHCl

Novartis 12/30/064-755-534 12/30/99

U-73NCE

Expired 415452.

Beconase+

Beclovent

Beclomethasone

dipropionateGlaxo-

Wellcome

12/21/994-364-92312/21/99

4-364-924





I S S N 0 7 9 3 6 9 4 X

Year of Expiration - 2000Drug OFFDrug OFF

PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


Vasotec Enalaprilat Merck &Co.

2/22/004-374-829

2/22/00-- Expired

02/22/00725860

Hismanal Astemizole JNJ-Janssen

4/3/004-219-559

M/D/YY -- Expired04/03/00

2833

Buspar BuspironeHCl

B-M-S 5/22/004-182-763

5/22/00 U-13 Expired05/22/00

540611

Lotrisone Betamethazone Diprop

Schering 10/06/004-298-604


201233

Pepcid Famotidine Merck& Co.

10/15/004-283-408


13501487

PepcidAC

Famotidine Merck& Co.

10/15/004-283-408 04/28/98

NS Expired10/15/00

125138

GlucotrilXL

Glipizide PfizerPratt --

11/25/00 NDF Expired11/25/00

179199

Intal Cormolynsodium

Rhone-Poulenc-

Rorer

9/20/004-405-598


8998

Glucophage

MetforminHCl

BMSquibb

3/03/00-

M/D/YY NCE Expired3/03/00

11101302.

Ultram TramadolHcl

J/J - McNeil P M/D/YY NCE Expired

03/03/00

453501.

ZIAC Bisoprololfumerate

AHPLederle

3/24/004-258-062 7/31/97

U-63NCE

03/24/00 173198

CEFTIN Cefuroximeacetil

GW 5/12/004-267-320


425485.

Atrovent IpratropiumBr

BIngelheim

5/24/004-385-048 10/20/98

NDFU-119

Expired05/24/00

306346

Cardura Doxazosinmesylate

Pfizer 10/18/004-188-390 2/6/98

NCE1-96

Expired10/18/00

330401

ZOLADEX GoserelinAcetate

Zeneca 4/22/994-100-274

6/27/00 --I-191

Expired06/27/00

219244

Sevo-flurane

ULTANE Abbott 12/26/044-250-334

6/7/00NCE Expired

06/07/00114134

Terazosin Hytrin Abbott 2/17/004-251-532


425598.

Neurontin Gabapentin WLAP Davis

01/16/00

5-084-479

12/30/98 U-106(Epilepsy)

Expired01/16/00

500590

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule




I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

Exclusivity

Expiry

Patent &Exclusivity

EarliestGeneric

199920001

Trade Generic NAME Patent # DATE CODES DATEMM/DD/YY

USD$(Mil)

Calcitriolinj

Calcijex Abbott 1/28/014-308-264

1/28/01 - 01/28/01 190210

Prilosec Omperazole

AstraZeneca

4/5/014-255-431

3/22/99 U-108I-23

10/01/01 34953540

Mertazapine

REMERON Organon P 6/14/01 NCE 06/14/01 132134

Mevacor Lovastin Merck & Co 6/15/014-231-938

2/8/98 -I-117

06/15/01 595300.

Accutane Isotretinoin Roche[Syntex]

8/7/014-464-394

M/D/YY -- 08/07/01 395462.

Brimonidine Alphagan Allergan P 9/06/01 -NCE

09/06/01 98101

PLENDIL Felodipine Merck& Co.

6/19/014-264-611

M/D/YY U-3 06/19/01 150178

Xalatan Latanoprost

Pharmacia P 6/05/01 NCE 06/05/01 507510

Levo-floxacin

levaquin RWJ -- 12/17/01 I-246 12/17/01 288310

Lovenox Enox-aparin Na

RPR 12/04/014-692-435

05/06/00 U-122NCEI-192

12/04/01 299320

Milrinone Primacor Sanofi 2/2/014-313-951

M/D/YY - 02/02/01 101110

Tercon-azole

TERAZOL J+J 11/09/014-358-449

M/D/YY - 11/09/01 103114

Lisinopril Zestril Astra-Zeneca

12/30/014-374-829

11/24/98 -I-141

12/30/01 600646

Lisinopril Prinivil Merck& Co.

12/30/014-374-829

11/24/98 I-141 12/30/01 350365







I S S N 0 7 9 3 6 9 4 X



GenericName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivit

y

EarliestGeneric

199920001


Axid Nizatidine Lilly 4/12/02

4-375-547

4/12/02 -- 04/12/02 340255

Suprax Cefixime AHP/

Lederle

10/11/02

4-409-214

M/D/YY -- 10/11/02 105

121

Effexor Venlafa-xine

AHP/

Wyeth

Ayerst

12/13/02

4-535-186

12/28/98 -

NCE

12/13/02 205

Cordarone Amio

darone

AHP/Wyeth

AyerstP

08/03/02 -

ODE

08/03/02 250

Optiray320

Ioversol Mallinc 12/30/024-396-598

M/D/YY -- 12/30/02 168

Optiray350

Ioversol Mallinc 12/30/024-396-598

M/D/YY -- 12/30/02 69

Monopril /Vasopril

(10.20mg)

FosinoprilNa

BMS 12/4/02

4-337-201

05/02/98 -

I-92

12/04/02 202

Relafen Nambutone Smith

Kline

Beecham

12/13/02

4-420-639

M/D/YY -- 12/13/02 450380

Trovaflox-acin

mesylate

TROVAN Pfizer -- 12/18/02 -

NCE

12/18/02 160155

Carvedilol Coreg SKB 3/5/024-503-067

9/14/00 U-3NCE

03/05/02 100101

Midazolam VERSEDinj

Roche 6/20/004-280-957

4/15/02 PED 04/15/02 324380







I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


Fluoxitine Prozac Lilly 12/2/034-626-549

M/D/YY - 12/02/03 22813200

Cipro Cipro-floxacin

Beyer/Miles

12/9/034-670-444

6/03/00 -

I-18812/09/03 908

997

Ketoconazole

NIZORAL JJ- 2/11/03

4-942-162

5/30/00 -

I-18602/11/03 158

180

Floxin Ofloxacin JNJ-

McNeil

09/02/034-382-892

12/16/00 -

I-17409/02/03 190

211

Flovent

Fluticasone

propionate

Glaxo

Wellcome

11/14/034-335-121

10/07/00 -

NDF11/14/03 294

301

Flonase

Flutica-

sone

propionate

Glaxo

Wellcome

11/14/034-335-121

10/19/97 -

NDF11/14/03 440

488

Serzone Nefaz

odone HCl

BMS 03/16/034-338-317

12/22/99 -

NCE03/16/03 239

255

Biaxin Clarithromycin

ABBOTT 5/25/034-331-803

M/D/YY 05/25/03 689749

Lotensin Benazepril Novartis 08/11/034-410-520

M/D/YY 08/11/03 295320

OrthoNOV 777

-28

Ethinyl

estradiol

OrthoJJ

9/26/034-628-051

12/31/99 -

-12/26/03 205

235

Ortho-TRI

Cyclin

Ethinyl

estradiol

OrthoJJ

9/26/034-628-051

12/31/99 U-66

I-17712/26/03 254

261







I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

TradeName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


Claritin Loratadine Schering 4/21/04

4-659-716

4/12/98 NCE

U-77

06/21/04 1340

1360

Claritin-D Loratadine/D

Schering 4/21/04

4-282-233

-

4/21/98

U-77NC

04/21/04 340345.

Claritin-D

24

Loratadine/D

Schering 4/21/04

4-282-233

8/23/99 U-77NP

04/21/04 320335

Claritin

ReadyTab

Loratadine Schering 4/21/04

4-659-716

4/12/98 NCEU-142

04/21/04 110115

Duragesic Fentanyl JNJ-

Janssen

7/13/044-588-580

M/D/YY U-43 07/13/04 290289

Diflucan Fluco-azole

PFizer 1/29/044-404-216

M/D/YY - -- - 01/29/04 495555

Carbplatin Paraplatin BMS 04/14/044-657-927

M/D/YY U-175 04/14/04 399435.

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product

NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales

U = Code for Therapeutic Use stillunder Patent Protection






I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


Quinapril Accupril WLambert 4/10/055-747-504

M/D/YY U210-

04/10/05 357386.

Pamidro-nate DiNa

Aredia Novartis 07/29/054-711-880

07/16/99 --I-158

07/29/05 242251

Retrovir Zidovudine GlaxoWellcome

9/17/054-837-208

M/D/YY - -- - 09/17/05 127157

Zithromax Azithro-mycin

Pfizer(Pliva)

10/14/054-517-359

M/D/YY - -- - 10/14/05 10801255.

Pravachol Pravastinsodium

BMS 10/20/054-346-227

M/D/YY 10/20/05 11301210

Zocor Simvastatin Merck& Co.

12/23/054-444-784

M/D/YY U-59I-128

12/23/05 19202090

Lorabid Loracarbef E. Lilly 11/24/054-708-956

M/D/YY - -- - 12/24/05 129165

Zofran Ondan-setron

Glaxo-Wellcome

06/25/054-695-578

04/19/98 U-183D-20

I-9 + I-151

06/25/05 510550.

LupronDepot-3

LuprolideAcetate

TAPPharm

07/03/054-677-191

-03/07/00

-NP

07/03/05 270298

LupronDepot-4

LuprolideAcetate

TAPPharm

07/03/054-677-191 05/30/00

-NS

07/03/05 122125

LupronDepot

LuprolideAcetate

TAPPharm

07/03/054-677-191

M/D/YY - -- - 07/03/05 255264

CEFZIL Cefprozil BMS 11/28/054-520-022

M/D/YY U-4 11/28/05 358390

Sporonox Itraconazole J & J 12/23/054-791-111

11/28/05 195238

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product

NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales

U = Code for Therapeutic Use stillunder Patent Protection






I S S N 0 7 9 3 6 9 4 X



GenericName

PatentHolder

Marketer

PatentExpiry

Exclusivity

Expiry

Patent &Exclusivit

y

EarliestGeneric

199920001


Proscar Finasteride Merck

& Co.

6/19/06

4-760-071

6/19/97NCE

06/19/06 255000

GEMZAR Gemcitabine E Lilly 2/28/06

4-808-614

5/15/01 NCE 02/28/06 215229

TIMOPTICXE

Timololmaleate

Merck

& Co.

08/29/06

4-861-769

M/D/YY 08/29/06 100111

Ambien Zolpiderm

Tartrate

SearleMonsanto

10/21/06

4-382-938

12/16/97 U-74NCE

10/21/06 575

638

K-DUR KCl S Plough 09/05/064-863-743

M/D/YYU-99 09/05/06 240

264

PAXIL ParoxitineHCl

SKB 12/29/064-721-723

12/29/97 NCEU-12

12/29/06 12051374

Prempro-14/14

Estrogenconjugated

AHPWyeth Ar

02/05/064-826-831

M/D/YY 02/05/06 460498

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection






I S S N 0 7 9 3 6 9 4 X



GenericName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


QUET-IAPINE

Seroquel Astra -Zen

03/20/07

4-879-288

9/26/02 -NCE

03/20/07 105112

Sibutramine HCl

MERIDIA KNOLL 5/29/07

4-929-629

11/22/02 -NCE

05/29/07 155165

Propulsid Cisapride

Mono-

hydrate

JNJ-

Janssen

10/9/07

4-962-115

07/29/98 U-79

NCE

10/09/07 500560

Kytril Grani-setron

S-K-B 12/29/074-886-808

12/29/98 NCE

U-89

12/29/07 269299

Risperdal Risperi -

done

JNJ-

Janssen

12/29/074-804-6635-158-952

10/17/00U-90D-37NCE

12/29/07[10/29/09]

690

733

ZytrecTabs/Syrup

CetirazineHCl

Pfizer 06/25/074-525-358

12/08/0O NCE 06/25/07 525601

Fosamax Allendro-nate Na

MerckCo.

08/06/074-621-0775-849-726

09/29/07 U-114NCE

08/06/07[06/06/15]

505

756

Aerobid Flunisolide Forrest 06/12/074-933-168 M/D/YY

- 06/12/07 220

245

LOTREL Amlodipine

Besylate

Novartis 3/25/07

4-879-303

07/31/97 NC 03/25/07 166187

NORVASC Amlodipine

Besylate

Pfizer 3/25/07

4-879-303

07/31/97 NCE 03/25/07 12051270

Camptosar irinotecanHCL

(oncology)

Pharm-acia

08/20/07

4-604-463

06/14/01 NCE 08/20/07 293299

Effexor XR Venlafaxine AHP-Wyeth

12/13/07

4-535-186

10/20/00 NDF 12/13/07 210

233

Suprane Desflurane BOCOhmeda

2/2/074-762-856

9/18/97 U-67NCE

02/02/07 8089




I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

Exclusivity

Expiry

Patent &Exclusivity

EarliestGeneric

199920001


Depakote Divalproexsodium

DR Tablets

Abbott 1/29/085-212-326 6/20/99

-I-181

01/20/08 694765

Casodex Bicalut-amide

Zenaca 10/01/084-636-505

10/4/00 -NCE

10/01/08 135144

Serevent SalmeterolXinafoate

AllenHanburys

2/12/084-922-4745-380-922

01/10/12 NCE 02/12/08[01/10/12]

280310

Neurontin Gabapentin WLAP Davis

05/02/084-894-476

12/30/98 NCE 05/02/08 500504

Neurontin Gabapentin WLAParkeDavis

01/16/004-087-544

12/30/98 U-106 [01/16/00] 500480

ZERIT Stavudine BMS 06/25/084-978-655

06/24/99 NCEU-94

06/25/08 241265

DDAVP DesmopressinAcetate

RhonePoulenc

Rorer

9/10/085-407-3985-763-407

M/D/YY 09/10/08[12/23/13]

170198

Lamictal Lamot-rigine

Cerenex 07/22/084-602-017

08/24/05 U106NCE+ODE

I-247

07/22/08[12/14/01]

135155

LamictalCD

Lamot-rigine

Cerenex 07/22/084-602-017

08/24/05I-247

[12/14/01] n/a

TRUSOPT Dorzol-amide HCl

Merck Co. 04/28/084-479-413 12/09/99

-NCE

04/28/08 115133

PROGRAF

Tacrolimus Fujisawa 04/08/084-894-366

M/D/YY 04/08/08 135139

Zemuron RocuroniumBr

Akzo-Organ 04/13/084-894-369

03/17/99 -NCE

04/13/08 115126

Altace Ramipril HoeschtRoussel

10/29/085-061-722

08/22/98 -I-134

10/29/08 121144

VALTREX Valacyclovir Glaxo-W 08/05/084-957-924

06/23/98 -NE

08/05/08 165178







I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


EPIVIR Lami-vudine

Glaxo 02/08/095-047-407

11/17/00 -NCE

02/08/09 260298

Tylenol Acetaminophen

JNJ-McNeil

8/11/094-000-000 M/D/YY

NDF 0/00/09 699780

Prevacid Lanso-prazol

TAPPPharm

05/10/094-628 098 05/10/00

-NCE

05/10/09 20382290

COZAAR LosartanPot.

MerckCo

10/06/095-153-197 4/14/00

-NCE

10/06/09 350398

Rispedal Risperi-done

J & JJansen

10/27/095-158-952 12/29/98

U-90NCE

10/27/09 9901106

HYZAARHydochlor-

thiazide Merck 08/11/095-153-197 4/14/99

U-3NCE

08/11/09 140178


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusiv

ity

EarliestGeneric

199920001


Neurontin Gabapentin WLAParkeDavis

01/02/105-084-479 12/30/98

-NCE

1/02/010 755902

Famvir Famciclovir SKB 09/21/105-246-937

6/29/99 U-96NCE

09/21/10 155185

Inverase Saquinavirmesalate

Roche 11/19/104-000-000

M/D/YY NCE 0/00/10 160178

Aricept Donepezil Pfizer 11/25/104-895-841

11/25/01 -NCE

11/25/10 300334

Sigular MontelukastNa

Merck 11/30/105-565-473

2/20/03 -NCE

11/30/10 198240







I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


Magnevist Gadopen-tetate

Dimeg-lumine

BERLEX 11/08/114-000-000

M/D/YY 0/00/11 99108

VIAGRA Sildenafil Pfizer 06/18/115-250-534

03/27/03 -NCE

06/18/11 9901289


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivit

y

EarliestGeneric

199920001


Eldepryl Selegiline MYL &WATS-

Somerset

04/23/125-242-950

06/05/96 04/23/12 180220

Zoloft Setraline PfizerRoerig

08/13/125-248-699

07/08/00 U-12 08/13/12 19001995

Serevent SalmeterolXinafoate

AllenHanburys

01/10/124-922-4745-380-922

02/04/9901/10/12

-NCE

[02/12/08]01/10/12

345388

DETROL TolterodineTartrate

PharmaciaUpJohn

01/17/125-382-600 03/25/03

-NCE

01/17/12 329360

DIOVAN Valsartan Novartis03/21/12

5-399-57812/23/01 U-12

NCE03/21/12 155

180

PLATINOL Cisplatin BMS05/08/12

5-562-925- -

-05/08/12 115

140

COMBIVIR

Lamivudine GW05/15/12

5-859-02111/17/00- U-248

NCE05/15/12 305

355

TAXOTERE Docetaxel

for Inj. RPR07/03/12

5-403-85805/14/01 -

NCE07/03/12 125

240ZOMEC Zolmitripta

n Astra

Zeneca11/14/12

5-466-69911/25/02- -

NCE11/14/12 98

115SUSTIVA Efavirenz 07/08/12

5-811-423 U-25607/08/12 N/A




I S S N 0 7 9 3 6 9 4 X



GenericName

PatentHolder

Marketer

PatentExpiry

+

ExclusivityExpiry

Patent &Exclusivit

y

EarliestGeneric

199920001


Wellbutrin BupropionHCl

Cerenex 08/12/134-507-323

M/D/YY - 08/12/13 155310

ZYBAN BupropionHCl

Cerenex 08/12/135-731-000

05/14/00NP

08/12/13 200289

ALLEGRA Fexo-fenadine

HCl

HoechstMarionRoussel

11/26/135-578-610

07/25/01 U-138NCE

11/26/13 360420

ALLEGRAD

Fexo-fenadine

HCl


11/26/135-578-610

12/24/00 U-138NC

11/26/13 105140

Zoloft Sertraline PfizerRoerig

8/13/125-249-699 08/07/00

NCE 08/13/12 16291780

Imitrex SumatriptanSuccinate

CerenexGlaxo

09/10/135-554-639

8/26/00 NDFU-72

09/10/13 898990

DDAVP DesmopressinAcetate

RhonePoulencRorer

9/10/085-407-3985-763-407

M/D/YY [09/10/08]12/23/13

170210

Accolate Zafirlukast AstraZeneca

01/06/135-482-963

- - 01/09/13 146159

CRIXIVAN IndinavirSulfate

MerckCo

05/07/135-413-999

3/13/01 U-132NCE

05/07/13 335356

ASACOL Mesalamine P&G 07/30/135-541-171

8/18/00 U-141I-203

07/30/13 163183

REZULIN Troglitazone Warner-L 09/13/135-478-852

01/29/02 U-163NCE

09/13/13 855930

Magnevist GadapentetateDi-meglumine

Berlex 10/01/135-560-903

- --

10/1/13 128155

Viracept NelfinavirMesalate

Agguron 10/07/135-484-926

03/14/02 -NCE

10/07/13 399410






DR U G S Off-PatentR e p o r t s

I S S N 0 7 9 3 6 9 4 X


NASONEXMometasone

Fumaratemonohydrate


01/27/145-837-699 10/01/00

-NDF

01/27/14 120

PLAVIX Clopidogrelbisulfate

BMS 01/31/145-576-328

11/17/02 -NCE

01/31/14 141188

ZYPREXA Olanzapine E Lilly 2/25/145-605-897

09/30/01 U-176U-149

2/25/14 13441455

LIPITOR AtorvastatinCa

WLPfizer

5/4/145-385-929

12/17/01 -NCE

5/4/14 20102112

EVISTA Raloxifene E Lilly 06/24/145-641-790

12/09/02 -NCE

06/24/14 121141

NORVIR Ritonavir Abbot 07/15/145-648-497

03/01/01 U-190NCE

07/15/14 138159

SUSTIVA Efavirenz 09/02/145-648-4975-663-169

U-25721/05/1309/02/14

N/A

Year of Expiration - 215rug OFFrug OFFPatentPatent

GenericName

PatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


Sporanox Itraconazole JNJ-Janssen

01/13/155-707-975

2/21/00 NCE/ NDFI-04, I-155

01/13/15 12191334

Diprivan Propofol AstraZenacca

030/22/155-714-520

6/11/199 -NP

03/22/15 349388

Prempro-14/14

estrogenconjugated

AHPWyeth Ar

1/17/155-547-948

M/D/YY - 01/17/15 460498

Miacalcin CalcitoninSalmon

Novartis 03/31/155-733-569

08/17/98 U-227NDF

13/31/15 185220

COREG Carvedilol SKB 06/07/155-760-069

- -U-233

06/07/15 158199

FOSAMAX AlendronateNa

MerckCo

06/06/155-849-726

09/29/00 -NCE

06/06/15 600689

ALLEGRA Fexo-fenadine

HCl


02/28/155-855-9125-738-872

12/24/00 U-138NC

02/28/15 [105+]185

PEPCIDAC

Famotodine Merck& Co.

06/06/155-854-267

09/29/00 U-267 06/06/15 600680




U-Codes apply topatent expiry only

I-Codes apply to exclusivity, ODE and all NEWpresentations and forms




I S S N 0 7 9 3 6 9 4 X


PatentPatentGeneric

NamePatentHolder

Marketer

PatentExpiry

ExclusivityExpiry

Patent &Exclusivity

EarliestGeneric

199920001


REBETOL Ribavirin ICN 01/23/165-767-097

12/09/01 -I-249

01/23/16 10000

AGGRASTAT

TibofibanHCl

Merck 10/23/165-733-919

05/14/03 -NCE

10/23/16 1632


PRELAY Trolitazone Sankyo 11/13/175-859-037

01/29/02 U-251NCE

11/13/17 N/AN/A

US GENERIC DRUG SALES FORCAST

8.249.34

10.93

13

14.5

16.9 17.1

21.8

0

5

10

15

20

25

1998 1999 2000 2001 2002 2003 2004 2005

Sales Year

US

D$

(Bill

ion

s)



Total $ Sales of Expiring Drugs - Next 10 Years

1.1

3.6

7.1 7.3

3.1

6.6

3.8

7

2.8

4

2

3.2

1.6

0

1

2

3

4

5

6

7

8

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

Expiration Year

Mar

ket

Val

ue

($B

illio

ns)

Generic Market Share of Total Rx Business

3540 42 43 43 44 47 47.2 48.4 49.1 50.5

0

10

20

30

40

50

60

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

Sales Year

% M

arke

t S

har

e

World Retail Rx Sales - $216.3 ($ Billions)

94

5.3

98.9

51.7

52.7

14.9

13.8

9.3

9.2

13.1

5.1

4.6

3.4

5.5

0 10 20 30 40 50 60 70 80 90 100

US

Canada

North Am.

Japan

Europe

Germany

France

Italy

UK

Spain

S America

Brazil

Mexico

Argentinia

RE

GIO

N

Rx Market Value - Key Markets

Retail Rx sales in Europeand Japan almost equal

Cardiovascular productsamount to $42 billion of total

Fastest growing segmentmusculoskeletal - $12 billion

patent expiry

Documents