BioPortfolio Limited Pharma Generic League - Market Analysis and Forecasts 2007 to 2012, 2017 and 2022

	Pharma Generic League - Market Analysis and Forecasts 2007 to 2012, 2017 and 2022
	1. Executive Summary 2. An Overview of The Leading Generics Producers in 2007 2.1 Generics Medicines Experience Significant Growth in 2006 2.2 Teva Records Largest Sales of Generic Pharmaceuticals Globally in 2006 3 The World Generics Market 3.1 The World Generics Market to Grow by over 12% Per Annum to 2010 3.2 Top 20 Companies To Lose Leading Products To Generic Competition 3.3 Price is the Principal Competing Factor in the Generics Market 3.4 Countries with Lowest Branded Drug Prices have the Highest Generic Growth 3.5 Patent Expiration is the Major Driver in All Generic Markets 3.6 The US Has The Largest Generics Market 3.7 The UK has the Highest Generic Penetration by Value in All European Markets 3.8 Japan An Isolated Case in the Generic Market 4. The US and European Regulation of Generic Drugs 4.1 Generic Pharmaceuticals in the US Market 4.2.1 The Hatch-Waxman Title I, 4.2.1.1 US Congress First To Market 180-Day Exclusivity Period Incentive 4.2.1.2 Bioequivalence An FDA Requirement 4.3 The Hatch-Waxman Act Title II has Promoted Innovation in the Branded Pharmaceutical Industry 4.4 The Hatch-Waxman Act Drives Influx Of Generic Pharmacuticals Significantly 4.5 Marked Difference In European Generics Patents Laws In Comparison With The US 4.6 European Generic Drug Development: Variation Between European Countries 4.7 EU Benefits From Long Data Exclusivity Protecting Patents 4.8 Additional EU Patent Protection is Afforded by Supplementary Protection Certificates 4.9 Compulsory Licensing Allows Generic Manufacture Before Patent Expiry 4.10 The WHO and Compulsory Licenses 4.11 Compulsory Licenses and the TRIPs Agreement 4.12 The Benefit of Being the First Generic to Market 4.12 The Advatages of First-to-Market Generics 4.13 Biogenerics A Continuously Expanding Market 4.14 Bioequivalence A Growing Concern For The Biogenerics Industry 4.15 US Biogenerics Regulatory Framework Awaits The Implementation of New Bills 4.16 European Drug Regulation Framework 4.17 European Medicines Agency (EMEA) Amends Its Biogeneric Regulation 5 TEVA Pharmaceutical Industries 5.1 Teva is Listed on Various Stock Exchanges, Including NASDAQ 5.2 Teva Achieved Sales of $8.4bn in 2006 5.2.1 Most of Teva's Sales are In North America 5.2.2 Most of Teva's Sales Are Generated by the Pharmaceuticals Division 5.2.3 Vision and Core Values in Teva 5.3 Human Pharmaceuticals Division 5.3.1 Teva Produces Generic Drugs in All Major Therapeutic Categories 5.3.2 Teva Markets and Develops Innovative Drugs for Specialised Markets 5.3.3 The Pharmaceuticals Division Contributes 90% of Teva's Revenues 5.3.4 Copaxone (glatiramer acetate) 5.3.5 Azilect (rasagiline) 5.4 Active Pharmaceutical Ingredients (API) Division 5.5 Teva USA 5.6 Veterinary Products 5.7 Key Acquisitions by Teva 5.7.1 Acquisition of Ivax Corporation in January 2006 5.7.2 Sicor became a wholly owned subsidiary of Teva in January 2004 5.7.3 Acquisition of Novopharm 5.8 A Brief History of Teva 5.8.1 Formation of the Company at the Start of the Twentieth Century 5.8.2 Growth During the WWII and the Establishment of the State of Israel during 1940s & 50s 5.8.3 Consolidation During the 1960s & 70s Establishment of Teva Pharmaceutical Industries Ltd 5.8.4 Further Acquisitions and Dominance During the 1980s 5.8.5 1990s: Expanding Presence Worldwide 5.9 Teva Benefited from an Ambitious Strategy of Acquisition 5.10 Teva Had Over 150 Products Awaiting FDA Approval at the End of 2006 5.11 Promising First Quarter Results for 2007 5.12 Copaxone - Teva's First Innovative Drug to Receive FDA Approval 5.12 Copaxone - Teva's First Innovative Drug to Receive FDA Approval 5.12.1 Steady Revenue Increase Expected for Teva's Flagship Product 5.12.1.1 Copaxone A Unique Immunomodulator Therapy For The Treatment of Relapsing-Remitting Multiple Sclerosis. 5.12.2 Copaxone Faces Present and Future Competitive Challenges in the Market 5.12.3 Copaxone Was Originally Licensed from the Weizmann Institute of Science 5.12.4 Copaxone is the Subject of Promising Clinical Studies 5.12.5 Lifecycle Management of Copaxone: Teva Makes Good Use of Collaborations 5.13 Azilect - Teva's Recently Launched Innovative Product 5.13 1 Azilect is Currently In a Period of High Early Growth 5.13.2 Azilect is a Potent Agent for Early and Advanced Parkinson's Disease 5.13.3 Azilect Benefits from Convenient Dosing 5.13 4 Azilect is Co-Marketed in Europe by Lundbeck and Teva 5.13.5 Co-Development of Azilect with Eisai 5.13.6 Phase IV Post-Marketing Study to Investigate Risk of Melanoma 5.13.7 Azilect May Have Potential in the Early Treatment of Parkinson's 5.13.8 Competition for Azilect 5.13.9 Azilect Has Performed Well in Clinical Studies 5.14 Teva Has a Diverse Generics Portfolio 5.14.1 Revenues from Generics Spread Over Many Products 5.14.2 Teva Receives First US Approval For Generic Uniretic Tablets 5.14.3 Teva Receives Approval For Generic Dostinex Tablets 5.15.4 Teva Announced Approval of Alprazolam ER Tablets 5.14.5 Teva Announced Its Launch of Generic Wellbutrin XL Tablets Through Agreement With Anchen And IMPAX 5.14.6 Teva Announced Tentative Approval Of Sumatriptan Succinate Tablets 5.14.7 Teva Receives Approval for Generic Focalin Tablets 5.14.8 Teva Announced Agreement with Pfizer Regarding Idarubicin, Azithromycin, And Epirubicin 5.14.9 Launch of Generic Zoloft by Teva 5.14.10 Final Approval of Venlafaxine HCL Tablets 5.14.11 Final Approval of Meloxicam Tablets 5.14.12 Tentative Approval of Generic Lotrel 5.14.13 Approval of Generic Zocor 5.14.14 Teva Received First FDA Approval for Generic Proscar Tablets 5.14.15 Tentative Approval of Losartan Potassium & Hydrochlorothiazide Tablets 5.14.16 Tentative Approval for Generic Cozaar Tablets 5.14.17 Tentative Approval of Simvastatin Tablets 5.14.18 Approval of Generic Lexapro Tablets 5.15 The Integration of Ivax's Operations Greatly Increased Teva's Strengths in Respiratory Drugs 15.16 Teva Pharmaceutical Market Forecast 2008-2013 & 2023 5.17 Pipeline Developments in Teva 5.17 1 Teva is Conducting R&D in Important Therapeutic Areas 5.17.2 Teva's Investment in R&D Has Been Rising in Recent Years 5.17.3 As a Leading Generic Producer Teva Has Progressed into Innovative Research & Development 5.18 Teva Has a Very Strong Generics Pipeline in Addition to Innovative Developments 5.18.1 R&D Focussed on Multiple Sclerosis, Autoimmune Diseases, Neurology and Oncology 5.18.2 Teva R&D is Concentrated in Four Divisions 5.19 Antineoplastics/Immunomodulating Agents 5.19.1 Stemex Cell Therapy 5.19.2 HMN 214 5.19.3 EDRATIDE (TV 4710) 5.19.4 SAIK-MS 5.19.5 LMB 9 5.19.6 Cervene (TP 38) 5.20 Central Nervous System Agents 5.20.1 Citicoline (IP 302) 5.20.2 Cladribine (NSC 105014F) 5.20.3 Fampridine-SR 5.20.4 Ladostigil 5.20.5 Valrocemide 5.21 Genitourinary System/Sex Hormones 5.22 Respiratory System Agents 5.22.1 Respicort 5.22.2 Other Agents in Development 5.23 Licensing Deal With Vaccinex for Monoclonal Antibody 5.24 Teva Collaborates on Protalix's Recombinant Plant Cell Expression Technology 5.25 Teva And Procognia (Israel) Ltd. Sign an Exclusive Collaboration Agreement for the Development of Biopharmaceuticals 6 Novartis' Sandoz 6.1 Sandoz is a Leading Supplier of Generics Internationally 6.1.1 Sandoz Has A Wide Product Range An Important Core Competencies 6.1.2 Sandoz Finally Benefits from Landmark Regulatory Decision Concerning Omnitrope 6.1.3 Sandoz 6.2 Novartis' Sandoz Generics Division 6.2.1 Background: Novartis Re-branded Its Generics Companies as Sandoz 6.3 Sandoz Has A Complex History From Establishment in 1886 to Present 6.4 Sandoz Has a Broad Product Range, Much of it Due to Acquisition of Generics Companies 6.5 Retail Generics Produces Finished Dosage Generic Forms 6.6 Sandoz Products: Retail Generics 6.7 Sandoz Products: Contract Biopharmaceuticals 6.8 Sandoz Products: Active Pharmaceutical Ingredients (API) 6.9 Sandoz Products: Product Intermediates 6.10 Sandoz Achieved Impressive Growth in 2006 6.11 Sandoz Will Achieve Strong Growth from 2008-2023 6.12 Sandoz Has Consolidated Its Market Position Through Acquisitions 6.12.1 Sandoz Acquisition Post-Unification: Sabex 6.12.2 Sandoz Acquisitions Post-Unification: Durascan 6.12.3 Novartis Bought Hexal and Eon in $7bn Deal 6.13 Sandoz Receives Landmark US and European Regulatory Approval for Omnitrope in 2006 6.13.1 Sandoz is Committed to The Emerging Field of Biosimilars - Generic Versions of Biopharmaceuticals 6.13.2 Sandoz Filed Lawsuit Against FDA Ruling on Omnitrope 6.13.3 Omnitrope Finally Received US and EU Approval in Early 2006 6.13.4 Omnitrope is a Ground-Breaking Product in the Generics Sector - With Far Reaching Implications for the Market 6.14 Sandoz Invests in Low Cost Production 6.15 The Outlook 2008-2023- Being Part of Novartis Will Confer a Significant Competitive Advantage upon Sandoz 6.15.1 Generics Market is Increasingly Competitive 6.15.2 Sandoz Generic Segment Forecast 2008-2013 & 2023 6.15.3 A Co-ordinated Strategy by Novartis Benefits Sandoz Greatly 6.15.4 Sandoz Will Continue to Gain Prominence in the World Generics Market 7. Merck KGaA 7.1 Merck KGaA is a Leading International Producer of Generic Pharmaceuticals 7.1.1 Merck - The Oldest Pharmaceutical Company in the World 7.1.2 The Structure of the Merck KGaA 7.1.3 The Generics Division Generates the Second Largest Sales in Merck's Pharmaceuticals Business Sector 7.1.4 Recent Developments in Merck Generics - Expansion of Core Business 7.2 Merck Generics Worldwide: the Merck KGaA group of companies 7.2.1 Alphapharm - Australia 7.2.2 Genpharm - Canada 7.2.3 Merck South Africa 7.2.4 Generics UK Limited 7.2.5 Dey Incorporated 7.2.6 Other Merck Companies Worldwide 7.3 Merck Generics Financials, 2006 7.3.1 Merck Has Two Types of Generics Markets 7.3.2 Generics Division Experiences The Highest Operating Results 7.3.3 France Sees Generic Expansion 7.3.3.1 Merck KGaA’s Spanish Market Experiences 47% Rise is Sales in 2006 7.3.4 Merck KGaA Sales Declines in UK and Germany 7.3.5 Integration of Dey as the Basis for Strategic Reorientation 7.3.6 Sales Rise in The US and Canada 7.3.7 Japan Experiences Sustained Revenue Growth 7.4 Merck KGaA Generics Segment Forecast, 2008-2013 & 2023 7.5 Merck Set to See Sustainable Generic Revenues Through Innovation of Product Life Cycle. 7.6 Major Developments in Merck Generics 7.6.1 Innovative Products for High-Growth Indications 7.6.2 Acquisition of NM Pharma from Pfizer 7.6.3 Litigation and Other Claims Against Subsidiaries Resolved 7.6.4 Merck To Leverage Its Position In Generic Respiratory Medicines 7.7 Merck's Strategic Acquisition of Serono Will Drive Revenues in the Long-Term 8. Ratiopharm 8.1 Ratiopharm Is a Pioneer In Generics Pharmaceuticals 8.2 RatioPharm Generics Segment 8.3 International Sales Drives RatioPharm's Revenue 8.4 Ratiopharm Leading Generics Sale 8.4.1 Ratiopharm Regional Sales 8.4.2 The US and Canadian Market 8.4.3 Sales Distribution in Africa, Asia and Australian Markets, 2006 8.4.3 Brazil Dominates Latin American Market 8.5 Ratiopharm Generic Segment Forecast 2008-2013 & 2023 8.6 Research And Development 8.6.1 Ratiopharm Commences Biogeneric Projects 8.6.1.1 Ratiopharm Enters Agreement With BioGeneriX and Neose 8.6.1.2 Ratiopharm and Neose's pegylated GCSF in Phase I Studies 8.7 Litigation and Agreements 8.7.1 Ratiopharm Successfully Challenges Patent Protecting AstraZeneca's Nexium (esomeprazole) 8.7.2 Court Rules Against Ratiopharm’s Lipitor Challenge 8.8 Mergers and Acquisition 8.8.1 Ratiopharm Acquires Magnafarma 8.8.2 Ratiopharm Other Key Acquisitions 9 Watson Pharmaceuticals 9.1 History and Background to Watson Pharmaceuticals 9.2 Watson's Generics Operations - A Large Product Portfolio Combined with A Strong Pipeline 9.3 Watson's Strategy - The Development of Technologically Challenging and High Demand Products 9.4 Watson Business Strategy 9.5 Watson R&D Expenditure Expands 9.6 Watson's Generic Product Range Accounts for Over Two Thirds of Net Sales 9.7 Watson's Branded Products Profit Margins decline in 2006 9.8 Merger Between Watson and Andrx Drives Sales of Generic Products 9.9 Watson Generics Segment Forecast, 2008-2013 & 2023 9.10 Watson New Generic Product Launches 9.11 Watson Puerto Rico Site to Close as Cost Saving Strategy 9.12 Watson Agreements 9.12.1 Agreement with GSK to Market Generic Zyban 9.12.2 Agreement with Proctor & Gamble to Distribute Generic Macrobid 9.12.3 Watson Terminates its Contract Sales Force Agreement With Ventiv Health 9.12.4 Litigation Proceedings - Possible Adverse Effects on Company Finances 9.13. Watson Alliances and Collaborations 9.14 Watson’s Branded Pharmaceutical Will Contribute Significantly To Year-on-Year Sales Growth 10 Actavis 10.1 Actavis Leading European Generic Company 10.2 Actavis Products Portfolio And Strategic Business Markets 10.3 Actavis Market Segmentation Market Segmentation 10.3.1. Actavis North American Markets Generates Highest Revenue 10.3.2 Actavis CEEA Markets Performance 10.3.3 Actavis WEMEA Markets 10.3.3.1 Actavis Sales in The UK Grows By 6% 10.3.3.2 Actavis Sales in Germany Declines 10.3.3.3 Actavis Experiences Sales Declines in The Netherlands 10.3.3.4 Actavis Scandanavian Market Grows 10.4 Actavis Third-Party Markets 10.5 Actavis Generics Segment Forecast, 2008-2013 & 2023 10.6 Actavis’ Pipeline - Strong Product Development and Investment in Manufacturing 10.6 1 Actavis’ ANDA Filings Increases Significantly In Both US And EU 10.6 2 Actavis Expands IP Project India and Iceland 10.6 3 Actavis And Colotech Investigates Cancer Chemoprevention Medicines 10.7 Mergers, Acquisitions and Agreements 10.7.1 Actavis Subsidiaries Expands 10.7.2 Actavis Acquires Alpharma 10.7.3 Actavis Establishes Global Hospital Business Unit (GHBU) 10.7.4 Actavis To Expand In-licensing Deals 10.8 Actavis Is Strongly Positioned To Maintain Status As a Leading Generics Supplier 11. Barr Pharmaceuticals Inc 11.1 Barr Has Developed A Strong Range of Therapeutic Core Competencies 11.2 Barr's Strengthens Portfolio Through Acquisition of Pliva 11.3 Barr Experiences Revenue Decline After Transition Period (July1-December 31) 11.4 Barr Products: Specialisation in Oral Contraception and HIV/AIDS 11.5 Barr Leading Products 11.6 Barr Key Financials 11.6.1 Barr Generics Revenue 11.6.2 Barr DDAVP (Desmopressin Acetate) 180 Days Marketing Exclusivity 11.6.3 Barr Exclusive Provider of Diadanosine Delayed-Release Capsules. 11.6.4 Court Denies Aventis Motion Against Barr's Generic Allegra 11.6.5 Barr Completes Isotrenioin Strength 11.6.6 Barr Completes Claravis (Isotrenioin) Strength 11.6.7 Barr Launches Leflunomide and Clonazepam Orally Disintegrating Tablets 11.7. Other Significant Barr Generic Launches 11.7.1 Barr’s Aranelle Generic Version of Watson’s Tri-Norinyl 11.7.2 Barr’s Kelnor Generic Version of Pfizer's Demulen 11.7.3 FDA Approves Barr’s Anagrelide Hydrochloride, Generic Version of Shire’s Agrylin 11.7.4 Barr's Duramed Expands Products With Shire's Adderall IR 11.7.5 Duramed To Market Seqsonique Extended-Cycle Oral Contraceptive In Leading Markets 11.7.6 Barr Markets Generic Glucophage (metformin hydrochloride) For Diabetes 11.7.7 Barr Investment In DTC Will Drive Products Growth 11.8 Pending Generic Patent Challenges 11.9 Barr Generics Segment Forecast, 2008-2013 & 2023 11.10. Proprietary Product Sales 11.10.1 Barr’s ParaGard IU - A Non-Hormonal Contraceptive Proprietary Franchise 11.10.2 Barr Doubles Women's Health Sales Force 11.10.3 Duramed’s Plan B OTC/Rx Emergency Contraceptive Receives Marketing Approval 11.10.4 Duramed’s Proprietary Drugs Portfolio Boosted By Pliva Acquisition 11.11 Barr Invests Significantly in R&D of Generic And Proprietary Products 11.11.1 Pliva Acquisition Strenghtens Barr R&D Pipeline Significantly 11.12 Barr's Alliances 11.13 Litigations Facing Barr 12 Stada Healthcare 12.1 Stada A Leading European Generics Pharmaceutical Company 12.2 Stada Key Competencies 12.3 Stada Regional Sales 12.4 Stada US Markets Revenue Declines 12.4.1 Stada Sales Reaches Newer Heights In The EU Market 12.4.2 Stada’s Key EU Markets Contributes Significantly To Yearly Sales 12.5 Stada Generics Division 12.5.1 Omeprazole - Stada’s Leading Product 12.6 Stada Branded Products 12.6.1 Stada’s Proprietary Products Sales Growth Exceeds 20% In 2006 12.7 Stada Generics Segment Forecast, 2008-2013 & 2023 12.8 Stada Product Developments 12.9 Mergers, Acquisitions and Disposals 12.9.1 Stada Acquires Significantly In 2007 12.10 Stada Initiates Biosimilar Projects 12.10.1 Stada And Bioceuticals Arzneitmittel’s Biosimilar Pipeline. 12.10.2 Stada Erythropoietin-Zeta (Epo-zeta)Receives Positive Opinion From EMEA 13. Mylan Laboratories 13.1 Mylan Was Originally a Packaging Company 13.2 Mylan Leading Therapeutic Classes 13.3 Mylan Records Highest Sale in US Market 13.3.1 Mylan Product Sales Grows In the EU Market 13.4 Mylan's Pharmaceuticals Product Porfolio Expands Significantly 13.5 Mylan's Recent Financial Results 13.6 Mylan New Product Lauches To Drive Revenue Growth 13.6.1 Mylan launched Amlodipine Besylate 13.6.2 Mylan's Oxybutynin ER Tablets 13.6.3 Mylan's Propranol hydrochloride ER capsules 13.6.4 Mylan's Other Major Launches 13.6.5 Mylan Generics Segment Forecast, 2008-2013 & 2023 13.7 Mylan Increases R&D Expenditure 13.7.1 Mylan Has A Strong Pipeline And Increased R&D Spending 13.8 Mergers, Acquisitions and Agreements 13.8.1 Mylan Completes The Acquisition of Matrix Laboratory Outstanding Shares 13.8.2 Mylan And Matrix Acquisition Will Intensify Antiretroviral Research 13.9 Legal Challenges on Products 13.9.1 Omeprazole 13.9.2 Lorazepam and Clorazepate 14. Apotex 14.1 Apotex Privately Owned Canadian Pharmaceutical Firm 14.2 Apotex Geneic Division 14.3 Apotex Experiences Continuous Growth Revenue 14.4 Apotex Regional Segmentation 14.4.1 EU Region Apotex’s Third Largest Market 14.4.2 Apotex’s Sales Growth Expands in Latin And Central American Markets 14.4.3 Apotex‘s Africa, Asia and Australia Generated The Least Sales In 2006 14.5 Apotex Leading Generic Drugs 14.5.1 Sanofi-Aventis And BMS Secure Injunction Against Apotex’s Leading Drug Clopidogrel 14.5.2 Apotex’s Omeprazole Sales Expands By A Significant Margin 14.6 Apotex Generics Segment Forecast, 2008-2013 & 2023 14.7 Apotex Research and Development 14.7.1 Apotex R&D Investment Drives Sales By Over 20% 14.7.2 Apotex R&D Projects Increases Innovative And Biotechnological Products 14.7.3 Apotex Markets Amlodopine Generic Version of Pfizer's Blockbuster Drug Norvasc 14.7.4 Apotex Intensifies Haematology And Skin Replacement Research 14.8 Apotex Second Larges