NEW PATENTED MEDICINES REPORTED TO PMPRB - 2008 (UPDATE AS OF NOVEMBER 30, 2008 - HIGHLIGHTED)

PMPRB 1

HUMAN DRUGS COMPANY BRAND NAME CHEMICAL NAME DIN THERAPEUTIC USE DATE OF

FIRST SALE STATUS

Abbott Laboratories Ltd. Kaletra 100/25 – 125 mg/tablet lopinavir/ritonavir 02312301 Treatment of HIV 22 Jul 2008 Under Review

Alcon Canada Inc. Tears Naturale Forte – 4 mg/mL dextran 70 / hypromellose / glycerin 02246397 Artificial Tears Jan 2003 (Patented 05 Feb 2008) Under Review

Advagraf – 0.5 mg/capsule 02296462

Advagraf – 1 mg/capsule 02296470 Astellas Pharma Canada Inc.

Advagraf – 5 mg/capsule

tacrolimus

02296489

Immunosuppresant 07 Apr 2008 Within Guidelines

Atacand – 32 mg/tablet candesartan cilexetil 02311658 Hypertension 17 Jul 2008 Under Review AstraZeneca Canada Inc.

Nexium – 10 mg/pouch esomeprazole magnesium 02300524 Treatment of Stomach Ulcers 02 Jan 2008 Within Guidelines

Advate 2000 antihemophilic factor (recombinant) 02313111 Treatment of Hemophilia A 03 Sept 2008 Under Review Baxter Corporation

Brevibloc Pre-Mix – 10 mg/mL esmolol hydrochloride 02309238 Beta Blocker 10 Jul 2007 (Patented 26 Aug 2008) Under Review

Angeliq 1/1 – 2 mg/tablet drospirenone/estradiol 17β 02268825 Hormone Replacement Therapy 20 Oct 2008 Under Review

Climara Pro – 5.79 mg / patch estradiol 17β / levonorgestrel 02250616 Menopause 25 Jun 2008 Under Review

Kogenate FS Bioset 2000 antihemophilic factor (recombinant) 02302225 Treatment of Hemophilia A 06 Aug 2008 Under Review

Xarelto – 10 mg/tablet rivaroxaban* 02316986 Venous Thromboembolism 18 Sept 2008 Under Review

Bayer Inc.

Zevalin – 1.6 mg/mL ibritumomab tiuxetan* Treatment of Non-Hodgkin’s Lymphoma

20 Jul 2004 (Patented 15 Jul 2008) Under Review

Biovail Pharmaceuticals Canada Glumetza – 1000 mg/tablet metformin hydrochloride 02300451 Diabetes 08 Jan 2008 Subject to Investigation

Pradax – 75 mg/capsule 02312433 Boehringer Ingelheim (Canada) Ltd.

Pradax – 110 mg/capsule dabigatran etexilate*

02312441 Venous Throembolic Events (VTE) 03 Jul 2008 Within

Guidelines

Revlimid – 5 mg/capsule 02304899

Revlimid – 10 mg/capsule lenalidomide*

02304902 Anemia 27 Feb 2008 Within

Guidelines

Revlimid – 15 mg/capsule 02317699 Celgene Corporation

Revlimid – 25 mg/capsule lenalidomide

02317710 Anemia 10 Oct 2008 Under Review

PregVit – tablet 02246067 Aug 2003 (Patented 18 Dec 2007) Duchesnay Inc.

PregVit Folic 5 – tablet multivitamins and minerals

02276194 Dietary Supplement Mar 2006

(Patented 18 Dec 2007)

Under Review

Cialis – 2.5 mg/tablet 02296888

Cialis – 5 mg/tablet tadalafil

02296896 Erectile Dysfunction 18 Jan 2008 Within

Guidelines

Cymbalta – 30 mg/capsule 02301482 Eli Lilly Canada Inc.

Cymbalta – 60 mg/capsule duloxetine hydrochloride*

02301490 Antidepressant/ Analgesic 18 Jan 2008 Within

Guidelines

NEW PATENTED MEDICINES REPORTED TO PMPRB - 2008 (UPDATE AS OF NOVEMBER 30, 2008 - HIGHLIGHTED)

PMPRB 2

Genzyme Canada Inc. Myozyme – 50 mg/vial alglucosidase alfa* 02284863 Treatment of Pompe’s Disease 09 Jan 2007 (Patented 29 Apr 2008) Under Review

Avamys – 27.5 mcg/dose fluticasone furoate 02298589 Allergic Rhinitis 22 Oct 2007 (Patented 22 Jul 2008) Under Review

Priorix Tetra live attenuated vaccine 02297884 Measles / mumps / rubella / varicella 09 Jun 2008 Under Review

Volibris – 5 mg/tablet 02307065 Under Review GlaxoSmithKline Inc.

Volibris – 10 mg/tablet ambrisentan*

02307073 Pulmonary Arterial Hypertension 24 Jun 2008

Under Review

Hoffman-La Roche Limited Valcyte – 50 mg/mL valganciclovir hydrochloride 02306085 Treatment of cytomegalovirus (CMV) infections 12 Aug 2008 Under Review

Intelence – 100 mg/tablet etravirine* 02306778 HIV 09 Apr 2008 (Patented 20 May 2008) Under Review

Natrecor – 1.5 mg/vial nesiritide* 02301393 Acute decompensated congestive heart failure 05 Feb 2008 Within

Guidelines Janssen-Ortho Inc.

Risperdal Consta – 12.5 mg/vial risperidone 02298465 Antipsychotic 08 Jan 2008 Within Guidelines

Johnson & Johnson Inc. Arestin – 1 mg minocycline hydrochloride 02278219 Adult peridontitus 28 Jul 2008 Under Review

Leo Pharma Inc. Fucidin - 250 mg/tablet fusidate sodium 01934252 Antibiotic Nov 1980 (Patented 18 Mar 2008) Under Review

Merck Frosst Canada Ltd. Januvia – 100 mg/tablet sitagliptin phosphate monohydrate* 02303922 Diabetes 02 Jan 2008 Within Guidelines

Diovan-HCT 320 / 12.5 – 332.5 mg/tablet 02308908 12 May 2008

Diovan-HCT 320 / 25 – 345 mg/tablet

valsartan / hydrochlorothiazide 02308916

Hypertension 12 May 2008

Within Guidelines

Exelon 5 – 9 mg/patch 02302845

Exelon 10 – 18 mg/patch rivastigmine

02302853 Alzheimer’s disease 12 Dec 2007 Under Review

Lucentis – 3 mg/vial ranibizumab* 02296810 Treatment of Neovascular (wet) Age-Related Macular Degeneration (AMD)

26 Jul 2007 (Patented 10 Jun 2008)

Within Guidelines

Stalevo 50 / 12.5 / 200 – 262.5 mg/tablet 02305933 28 Apr 2008

Stalevo 100 / 25 / 200 – 325 mg/tablet 02305941 28 Apr 2008

Novartis Pharma Canada Inc.

Stalevo 150 / 37.5 / 200 – 387.5 mg/tablet

levodopa / carbidopa / entacapone

02305968

Parkinson’s disease

28 Apr 2008

Within Guidelines

Nycomed Canada Inc. Omnaris – 50 mcg/dose ciclesonide 02303671 Allergies 10 Apr 2008 Within Guidelines

Oryx Pharmaceuticals Inc. Advicor 1000/40 – 1040 mg/tablet niacin / lovastatin 02293501 Cholesterol 07 Dec 2007 Within Guidelines

Eraxis – 100 mg / vial anidulafungin* 02302160 Antifungal 05 Feb 2008 Within Guidelines

Zeldox - 20 mg / capsule 02298597

Zeldox – 40 mg / capsule 02298600

Pfizer Canada Inc.

Zeldox – 60 mg / capsule

ziprasidone hydrochloride*

02298619

Antipsychotic 09 Jan 2008 Within Guidelines

NEW PATENTED MEDICINES REPORTED TO PMPRB - 2008 (UPDATE AS OF NOVEMBER 30, 2008 - HIGHLIGHTED)

PMPRB 3

Zeldox – 80 mg / capsule 02298627

Biphentin - 10 mg/capsule 02277166 Jul 2006 (Patented 12 Feb 2008)

Biphentin - 15 mg/capsule 02277131 Jul 2006 (Patented 12 Feb 2008)

Biphentin - 20 mg/capsule 02277158 Jul 2006 (Patented 12 Feb 2008)

Biphentin - 30 mg/capsule 02277174 Jul 2006 (Patented 12 Feb 2008)

Biphentin - 40 mg/capsule 02277182 Jul 2006 (Patented 12 Feb 2008)

Biphentin - 50 mg/capsule 02277190 Jul 2006 (Patented 12 Feb 2008)

Biphentin - 60 mg/capsule 02277204 Jul 2006 (Patented 12 Feb 2008)

Purdue Pharma

Biphentin - 80 mg/capsule

methylphenidate hydrochloride

02277212

ADHD

Mar 2007 (Patented 12 Feb 2008)

Under Review

Sanofi-aventis Canada Inc. Lantus Solostar – 100 unit/mL insulin glargine 02294338 Diabetes 07 Jan 2008 Subject to Investigation

Teva Neuroscience Frova – 2.5 mg/tablet frovatriptan succinate* 02257084 Migraine 04 Jan 2008 Within Guidelines

Benefix – 500 unit/vial coagulation factor IX (recombinant) 02293773 Hemophilia B 09 Jan 2008 Subject to Investigation

Benefix – 2000 unit/vial coagulation factor IX (recombinant) 02293803 Hemophilia B 10 Jul 2008 Under Review

Relistor – 20 mg / mL methylnaltrexone bromide* 02308215 Constipation due to opioid therapy 22 May 2008 Within

Guidelines Wyeth Pharmaceuticals

Torisel – 25 mg/vial temsirolimus* 02304104 Renal Cell Cancer 20 Feb 2008 Within Guidelines

YM Biosciences Inc. Nimotuzumab – 50 mg/vial nimotuzumab* Cancer 18 Aug 2008 Under Review

TOTAL: 69 DINs 08(1) 43 DINs 08(2) 26 DINs * New Active Substance