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									           Mylan Inc. – Product Pipeline Review – H2 2011
                                                                                          Reference Code: GMDHC01776CDB

                                                                                                 Publication Date: NOV 2011




Mylan Inc. – Product Pipeline Review – H2 2011                                              GMDHC01776CDB / Published NOV 2011

© Global Markets Direct. This report is a licensed product and is not to be photocopied                                 Page(1)
Mylan Inc. – Product Pipeline Review




Ta b le o f Co n te n ts
Table of Contents ..................................................................................................................................................................................................... 2
      List of Tables...................................................................................................................................................................................................... 7
      List of Figures .................................................................................................................................................................................................... 9
Mylan Inc. Snapshot ................................................................................................................................................................................................10
      Mylan Inc. Overview ..........................................................................................................................................................................................10
      Key Information .................................................................................................................................................................................................10
      Key Facts ..........................................................................................................................................................................................................10
Mylan Inc. – Research and Development Overview .................................................................................................................................................11
      Key Therapeutic Areas ......................................................................................................................................................................................11
Mylan Inc. – Pipeline Review ...................................................................................................................................................................................13
      Pipeline Products by Stage of Development ......................................................................................................................................................13
      Pipeline Products – Monotherapy .....................................................................................................................................................................14
      Pipeline Products – Combination Treatment Modalities .....................................................................................................................................15
Mylan Inc. – Pipeline Products Glance ....................................................................................................................................................................16
      Mylan Inc. – Late Stage Pipeline .......................................................................................................................................................................16
            Phase III Products/Combination Treatment Modalities ................................................................................................................................16
      Mylan Inc. Clinical Stage Pipeline Products .......................................................................................................................................................17
            Phase II Products/Combination Treatment Modalities .................................................................................................................................17
Mylan Inc. – Drug Profiles........................................................................................................................................................................................18
      Fluticasone Propionate......................................................................................................................................................................................18
            Product Description ....................................................................................................................................................................................18
            Mechanism of Action...................................................................................................................................................................................18
            R&D Progress .............................................................................................................................................................................................18
      Fluticasone Propionate + Formoterol Fumarate.................................................................................................................................................19
            Product Description ....................................................................................................................................................................................19
            Mechanism of Action...................................................................................................................................................................................19
            R&D Progress .............................................................................................................................................................................................19
      Perforomist + Fluticasone Propionate................................................................................................................................................................20
            Product Description ....................................................................................................................................................................................20
            Mechanism of Action...................................................................................................................................................................................20
            R&D Progress .............................................................................................................................................................................................20
      Perforomist + Tiotropium Bromide .....................................................................................................................................................................22
            Product Description ....................................................................................................................................................................................22
            Mechanism of Action...................................................................................................................................................................................22
            R&D Progress .............................................................................................................................................................................................22
Mylan Inc. – Pipeline Analysis .................................................................................................................................................................................24
      Mylan Inc. – Pipeline Products by Therapeutic Class ........................................................................................................................................24
      Mylan Inc. - Pipeline Products By Target ...........................................................................................................................................................25
      Mylan Inc. – Pipeline Products by Route of Administration ................................................................................................................................26
      Mylan Inc. – Pipeline Products by Molecule Type ..............................................................................................................................................27
Mylan Inc. - Dormant Projects..................................................................................................................................................................................28
Mylan Inc. – Company Statement ............................................................................................................................................................................29
Mylan Inc. – Locations And Subsidiaries..................................................................................................................................................................31
      Head Office .......................................................................................................................................................................................................31
      Other Locations & Subsidiaries .........................................................................................................................................................................31
Recent Developments .............................................................................................................................................................................................33




Mylan Inc. – Product Pipeline Review – H2 2011                                                                                                             GMDHC01776CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                               Page(2)
Mylan Inc. – Product Pipeline Review



         Dec 31, 2007: Mylan Announces Final FDA Approval for Balsalazide Disodium Capsules ..........................................................................33
         Jan 31, 2007: Mylan Announces Tentative Approval For Valacyclovir Hydrochloride Tablets ......................................................................33
         Apr 30, 2007: Mylan Remains the Only Approved ANDA for All Strengths of Amlodipine Besylate Tablets. ................................................33
         Jan 30, 2007: Mylan Announces Final FDA Approval for Albuterol Sulfate Extended-Release Tablets. ......................................................34
         Apr 29, 2008: Mylan Announces Final FDA Approval for Trandolapril Tablets .............................................................................................34
         Jan 29, 2010: Mylan Receives USFDA Approval For Generic Version Of GoLytely.....................................................................................34
         Apr 28, 2010: Mylan Receives Approval For Generic Version Of Flomax ....................................................................................................35
         Mar 28, 1996: Mylan receives approval on Indapamide Tablets ..................................................................................................................35
         Feb 28, 2011: Mylan Receives Approval For Generic Version Of Neurontin Capsules ................................................................................35
         Feb 28, 2007: Mylan Announces Launch of Quinapril Tablets, USP and Quinapril Hydrochloride and Hydrochlorothiazide Tablets ............35
         Jan 28, 2011: Mylan Receives Approval For First-to-File Generic Sular Extended-Release Tablets............................................................36
         Jan 28, 2009: Mylan Receives Final FDA Approvals for Generic Versions of Lamictal Tablets and Lamictal CD.........................................36
         Jan 28, 2002: Mylan Receives Tentative FDA Approval for Mirtazapine Tablets. ........................................................................................37
         Oct 27, 2011: Mylan Receives Approval For Generic Version Of MS Contin Tablets...................................................................................37
         May 27, 2010: AstraZeneca Stipulates Entocort Patent Suit with Mylan ......................................................................................................37
         Jan 27, 2006: Mylan Announces Final FDA Approval for Alprazolam Extended-release Tablets .................................................................37
         May 26, 2010: Mylan Receives Approval For Generic Version Of Valtrex ...................................................................................................37
         Apr 26, 2010: Mylan Begins Marketing First Generic Version Of Desoxyn ..................................................................................................38
         Mar 26, 2007: Mylan Announces Another First to Market With the Launch of Ciprofloxacin Extended-Release Tablets. .............................38
         Sep 25, 2000: U.S F.D.A Approves Mylan's Bisoprolol Fumarate and Hydrochlorothiazide Tablets ............................................................38
         May 25, 2010: Mylan Launches Temazepam Capsules USP, 7.5 mg .........................................................................................................38
         Apr 25, 2011: Mylan Launches First Generic Version Of Femara Tablets ...................................................................................................39
         Oct 24, 2000: Mylan Laboratories Assures Patients and Physicians of Mylan's Clozapine Bioequivalence to Novartis' Clozapine ..............39
         May 24, 2006: Mylan Announces Tentative Approval for Sumatriptan Succinate Tablets ............................................................................39
         Dec 23, 2003: Mylan Updates Litigation Status on Paclitaxel ......................................................................................................................39
         Aug 23, 2004: Mylan Receives FDA Approval for Metoprolol Tartrate and Hydrochlorothiazide Tablets ......................................................40
         Jun 23, 2011: Mylan Launches Generic Version Of Entocort EC Capsules .................................................................................................40
         Apr 23, 2007: Mylan Announces Final FDA Approval and Immediate Shipment of Zolpidem Tartrate Tablets .............................................40
         Mar 23, 2007: Mylan Laboratories Launches Amlodipine Besylate Tablets and Has Triggered Its 180 Days of Exclusivity. ........................41
         Oct 22, 2008: Mylan Receives Tentative FDA Approval for First-to-File Generic Version of Blood Pressure Drug Benicar HCT..................41
         Oct 22, 2008: Mylan Receives Tentative FDA Approval for First-to-File Generic Version of Blood Pressure Drug Benicar HCT..................41
         Jul 22, 2010: Mylan Announces Settlement Agreement for Namenda .........................................................................................................42
         Jul 22, 2010: Mylan Launches Generic Version Of Solodyn Tablets For Treatment Of Acne.......................................................................42
         Feb 22, 1995: Mylan received approval on Gemfibrozil Tablets ..................................................................................................................43
         Jan 22, 2004: Mylan Receives FDA Approval for New Strength -25mg- Metoprolol Tartrate .......................................................................43
         Oct 21, 2010: Mylan Receives Approval For Generic Version Of Mirapex Tablets ......................................................................................43
         Sep 21, 2010: Mylan Receives Approval For Generic Version Of Prograf Capsules....................................................................................44
         May 21, 2008: Results From Dey, L.P Funded Studies Showed Concomitant Treatment With Nebulized Formoterol Fumarate And
         Tiotropium Causes Significant Improvements In COPD ..............................................................................................................................44
         Dec 20, 2005: Mylan Announces Supply Agreement with Ortho-McNeil on Oxybutynin. .............................................................................44
         Dec 20, 2002: Mylan is Granted Summary Judgment on all Three Strengths of Mirtazapine. ......................................................................45
         Jul 20, 2006: Mylan Announces Final Approval for Meloxicam Tablets .......................................................................................................45
         Apr 20, 2011: Mylan Launches Generic Version Of Famvir Tablets.............................................................................................................45
         Jan 20, 2011: Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR For Lamivudine And Zidovudine Tablets, 30mg/60mg ....45
         Dec 19, 2005: Mylan Announces Final Approval for Bisoprolol Fumarate Tablets, USP ..............................................................................46
         Oct 19, 2006: U.S. District Court Grants Mylan's Motion to Dismiss the '909 Patent in the Amlodipine Besylate Litigation ..........................46
         Jul 19, 2010: Mylan Receives FDA Approval For Generic Version Of Catapres-TTS ..................................................................................47
         Jun 19, 2003: Mylan Receives FDA Approval for Mirtazapine Tablets.........................................................................................................47




Mylan Inc. – Product Pipeline Review – H2 2011                                                                                       GMDHC01776CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                 Page(3)
Mylan Inc. – Product Pipeline Review



         Apr 19, 2010: Mylan Launches Clozapine Tablets USP, 50mg And 200mg In US .......................................................................................47
         Apr 19, 2010: Mylan Receives Approval Under PEPFAR For Generic Version Of Videx EC HIV Treatment ...............................................47
         Apr 19, 2004: Mylan Confirms Mirtazapine Settlement. ...............................................................................................................................48
         Jun 18, 2010: Mylan Receives Approval For Generic Version Of Zocor Tablets ..........................................................................................48
         Apr 18, 2007: FDA Confirms Mylan's Status as the Only Approved ANDA for all Strengths of Amlodipine Besylate Tablets. ......................48
         Apr 18, 2005: Mylan Receives Approval for Anagrelide Hydrochloride Capsules ........................................................................................49
         Jan 18, 2011: Mylan Receives Approval For Generic Version Of Precose Tablets ......................................................................................49
         Nov 17, 2008: Mylan Receives Tentative FDA Approval For The Generic Version Of The Antidepressant Effexor XR ................................49
         Jun 17, 2010: Mylan Receives Approval For Hydroxyzine Hydrochloride Tablets ........................................................................................50
         Feb 17, 2000: Mylan Announces Approvals ................................................................................................................................................50
         Dec 16, 2004: Mylan Receives Approval for Propoxyphene Hydrochloride Capsules USP, 65mg ...............................................................50
         Oct 16, 2000: Watson Pharmaceuticals to Market First FDA Approved Levothyroxine Sodium Product. .....................................................50
         Jun 16, 2008: Mylan Announces Final FDA Approval For Generic Version Of Antidepressant Effexor ........................................................51
         Oct 15, 2010: Mylan Receives Approval For Generic Version Of Cozaar ....................................................................................................51
         Oct 15, 2010: Mylan Receives FDA Approval For Generic Version Of Hyzaar ............................................................................................52
         Aug 14, 2006: Mylan Announces Tentative Approval For Venlafaxine Hydrochloride Tablets......................................................................52
         Jul 14, 2010: Mylan Receives Approval For Nabumetone Tablets ...............................................................................................................52
         Jan 14, 2010: Bedford Laboratories Offers Unique 100 mg/50 ml Antifungal Agent Fluconazole Injection...................................................52
         May 13, 2011: Mylan Launches First Generic Amrix Capsules ....................................................................................................................53
         May 13, 2011: Mylan Launches Generic Risperdal M-Tab ..........................................................................................................................53
         Apr 13, 2007: Mylan Announces Final FDA Approval for Glipizide and Metformin Hydrochloride Tablets ....................................................53
         Dec 12, 2007: Mylan Inc. Announces Tentative FDA Approval for Lamotrigine Tablets ...............................................................................53
         Aug 12, 2011: Mylan Launches Generic Version Of Uroxatral Tablets ........................................................................................................54
         Apr 12, 2010: Mylan Receives Approval For Generic Version Of Hyzaar ....................................................................................................54
         Apr 12, 2010: Mylan Wins Approval For Generic Version Of Wellbutrin SR.................................................................................................54
         Dec 11, 2009: Mylan Receives The Approval OF Levetiracetam From The U.S. Food And Drug Administration (FDA) ..............................54
         Aug 11, 2009: Mylan Receives FDA Approval For Generic Version Of Migraine Treatment Imitrex .............................................................55
         Jun 11, 2002: Mylan Receives Approval on Levothyroxine Sodium Tablets. ...............................................................................................55
         Feb 11, 2004: Mylan Receives FDA Approval for Benazepril Hydrochloride Tablets and Benazepril Hydrochloride and Hydrochlorothiazide
         Tablets........................................................................................................................................................................................................55
         Dec 10, 2010: Mylan Receives FDA Approval For Hypertension Drug ........................................................................................................56
         Nov 10, 2006: Mylan Receives Final FDA Approval for Oxybutynin Chloride Extended-release Tablets......................................................56
         Jun 10, 2004: Mylan Receives FDA Approval for Ciprofloxacin Tablets ......................................................................................................56
         Jul 09, 2002: Mylan Receives Approval for Nizatidine Capsules. ................................................................................................................56
         Dec 08, 2009: Mylan Announces Settlement Agreement Related To Antidepressant Effexor XR ................................................................57
         Nov 08, 1993: Mylan CV Drugs Approved In USA.......................................................................................................................................57
         May 07, 2008: Mylan Announces Final FDA Approval For Ropinirole Hydrochloride ...................................................................................57
         Apr 07, 2010: Mylan Receives Approval for Generic Version of NuLytely ....................................................................................................58
         Dec 06, 2001: Mylan Receives Approval for Phenytek Bertek Pharmaceuticals Inc. to Offer Convenient, New Once-Daily Capsule FDA
         Affirms Bioequivalence to Dilantin Kapseals. ..............................................................................................................................................58
         Sep 06, 2007: Mylan Announces Final FDA Approval for Carvedilol Tablets ...............................................................................................58
         Feb 06, 2006: Mylan, Inc. Announced The US FDA Approval for Cyclobenzaprine Hydrochloride Tablets USP, 5 mg. ...............................59
         Feb 06, 2004: Appellate Court Stays Injunction in Mylan's Paclitaxel Case .................................................................................................59
         Oct 05, 2010: Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR For Generic Version Of Reyataz Capsules .....................59
         Apr 05, 2004: Mylan Announces Tentative Approval for Risperidone Tablets; Potential First-to-File Opportunity ........................................60
         Oct 04, 2010: Mylan Receives FDA Approval For Fludarabine Phosphate Injection For Treatment Of B-Cell Chronic Lymphocytic Leukemia
         ...................................................................................................................................................................................................................60
         Oct 04, 2005: Mylan Announces Final Approval for Amlodipine Besylate Tablets .......................................................................................60
         Jun 04, 2010: Mylan Receives Approval For Generic Version Of NeurontinTablets.....................................................................................60




Mylan Inc. – Product Pipeline Review – H2 2011                                                                                                             GMDHC01776CDB / Published NOV 2011

©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                                                 Page(4)
Mylan Inc. – Product Pipeline Review



           Jun 04, 1999: Mylan Announces Approvals ................................................................................................................................................61
           May 04, 2010: Mylan Receives Approval For Generic Version Of Zyban.....................................................................................................61
           Apr 04, 2011: Mylan Receives Approval For Generic Version Of Xalatan Ophthalmic Solution ...................................................................61
           Nov 03, 2005: Court Denies Pfizer's Summary Judgment Motion in Amlodipine Litigation With Mylan ........................................................62
           May 03, 2007: Mylan Announces Tentative FDA Approval for Letrozole Tablets, USP................................................................................62
           Dec 02, 2008: Mylan Announces Settlement Agreement with Novartis Related to Femara First- to-File Opportunity...................................62
           Jul 02, 2004: Mylan Enters Into a Settlement and License Agreement Ending Paclitaxel Litigation .............................................................63
           Jul 02, 2002: Mylan Receives Approval for Lisinopril and Lisinopril/HCTZ................................................
								
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