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Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil
Espicom Business Intelligence Ltd, April 2007, Pages: 190
FOREWORD
EXECUTIVE SUMMARY
REGULATORY ENVIRONMENT OF GENERIC MEDICINES IN BRAZIL
Regulation of Generic Medicines
Regulation of Similar Medicines
Future Regulation of Biosimilar Medicines
Registration of Generic Medicines
How to Register Generic Medicines
Centres to Perform Bioquivalence Studies
Registrations of Generic Medicines
Marketing Authorisations of Generic Medicines
Labelling & Packaging of Generic Medicines
Proposal to Include the Reference Drug Name
Indian Producer Targeting Packaging of Generic Medicines
Patent Protection & Intellectual Property Rights
Lobbying Against Patent Extensions in the Pipeline System
Deal Agreed to Reduce the Price of Abbott’s Kaletra
Pricing Policies
Implications for the Industry
Excessive Taxes on Drugs
New Drug Discounts in the Public Sector
Pricing of Generic Medicines
OVERVIEW OF THE GENERICS MARKET IN LATIN AMERICA
OVERVIEW OF THE PHARMACEUTICAL MARKET IN BRAZIL
MARKET FOR GENERIC MEDICINES IN BRAZIL
Sales of Generic Medicines in the Pharmacy Sector
Market Projections for Generic Medicines
Market Outlook for Generic Medicines
Production of Oral Generic Contraceptives & Hormones
More Uniform Market Penetration Across all the Regions
Unsustainable Reliance on Original HIV/AIDS Medicines
Foreign Generic Producers Squashed by Local Competition
Sales Strategies Devised by Producers of Generic Medicines
Potential Government Production of Bioequivalent Generic Medicines
Original Drugs with Patents Close to Expiry
Challenges in the Public Sector
Teva’s Acquisition Possibilities in Brazil
Generics, High Cost Savings but Low Prescription Levels
Domestic Production of Generic Medicines
Pólo Farmoquímico de Goiás
Investments Undertaken by Producers of Generic Medicines
Relevant Trade Associations
ALANAC
ALFOB
Pró-Genéricos
DOMESTIC PRODUCERS OF GENERIC MEDICINES IN BRAZIL
Aché
Product Portfolio
Biosintetica’s Product Portfolio
Financial Indicators
Biosintética’s Financial Indicators
R&D
Manufacturing Capabilities
Biosintética’s Manufacturing Capabilities
Contact Details
Americano de Farmacoterapia (FARMASA)
Product Portfolio
Financial Indicators
R&D
Manufacturing Capabilities
Contact Details
Arrow (Erowlabs)
Product Portfolio
Manufacturing Capabilities
Contact Details
Brainfarma
Product Portfolio
Financial Indicators
Manufacturing Capabilities
Contact Details
Cimed
Product Portfolio
Financial Indicators
R&D
Manufacturing Capabilities
Distribution Facilities
Contact Details
Cristália
Product Portfolio
Financial Indicators
R&D
Manufacturing Capabilities
Contact Details
EMS Sigma Pharma
Product Portfolio
Financial Indicators
R&D
Manufacturing Capabilities
Contact Details
Eurofarma
Product Portfolio
Financial Indicators
R&D
Manufacturing Capabilities
Contact Details
Hipolabor
Product Portfolio
Manufacturing Capabilities
Contact Details
LAFEPE
Product Portfolio
Financial Indicators
Manufacturing Capabilities
Contact Details
Medley
Product Portfolio
Extended Exclusivity Deal with Abbott
International Agreements
Financial Indicators
Manufacturing Capabilities
Contact Details
Neo Química
Product Portfolio
Financial Indicators
R&D
Manufacturing Capabilities
Distribution Facilities
Contact Details
Prati, Donaduzzi
Product Portfolio
Manufacturing Capabilities
Contact Details
Teuto
Product Portfolio
Financial Indicators
Manufacturing Capabilities
Contact Details
União Química
Product Portfolio
Financial Indicators
Manufacturing Capabilities
Contact Details
MULTINATIONAL PRODUCERS OF GENERIC MEDICINES IN BRAZIL
Abbott
Product Portfolio
Manufacturing Capabilities
Contact Details
Apotex
Product Portfolio
Contact Details
Mepha - ratiopharm
Product Portfolio
Financial Indicators
Planned Manufacturing Capabilities
Contact Details
Merck KGaA
Product Portfolio
Financial Indicators
Production Capabilities
Contact Details
Ranbaxy
Product Portfolio
Financial Indicators
Manufacturing Capabilities
Contact Details
Sandoz
Product Portfolio
Financial Indicators
Production Capabilities
Contact Details
KEY NATIONAL DATA PROJECTIONS
APPENDICES
DIRECTORY
Government Organisations
Producers of Generic Medicines
Trade Associations
List of Tables
National Bioequivalence Centres Authorised by ANVISA, 2007
International Bioequivalence Centres Authorised by ANVISA, 2007
Active Ingredients, Registrations & Presentations of Generic Medicines, 2000-2006
Cumulative Active Ingredients, Registrations & Presentations of Generics, 2000-2006
Registrations of Generic Medicines by Product Type, 2006
Registrations of Generic Medicines by Product Type, 2006 (%)
Registrations of Generic Medicines by Origin, 2006
Registrations of Generic Medicines by Producer, 2006
Original Drugs with the Highest Number of Generic Registrations, January 2007
Producers with Generic Registrations of Leading Original Drugs, January 2007
Marketing Authorisations of Generic Medicines by Producer, July 2006
Registrations & Marketing Authorisations of Generics by Producer, 2006
Drugs with the Highest Number of Generics Marketing Authorisations, July 2006
Producers with Generic Marketing Authorisations to Leading Drugs, July 2006
Marketed Active Ingredients, Registrations & Presentations of Generics, 2005
Marketed Generic Medicines by Origin, July 2005
Drug Price Adjustments, 2003-2006 (%)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (US$ Million)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (Million Units)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
Summary of the Brazilian Pharmaceutical Market, 2007
Brazilian Pharmaceutical Market by Value & Volume, 1997-2006
Brazilian Pharmacy Sector by Value & Volume, 2003-2006
Brazilian Pharmacy Sector by Value, 1997-2005
Pharmacy Sales of Generic Medicines by Value, 2000-2006
Pharmacy Sales of Generic Medicines by Leading Producer, 2006
Pharmacy Sales of Generic Medicines by Origin, 2006 (%)
Pharmacy Sales of Generic Medicines by Volume, 2000-2006
Sales of Generic Medicines by Month as % of the Pharmacy Sector, 2005-2006
Generics Market Projections, 2007-2012
Generics & Total Pharmaceutical Market Projections, 2007-2012 (US$ billion)
Original Drugs with Patent Close to Expiry, 2006-2013
SWOT Analysis of the Market of Generic Medicines, 2007
Workforce by Leading Producers of Generic Pharmaceuticals in Goiás
Members of ALANAC, 2006
Members of ALFOB, 2006
Pró-Genéricos’ Members, 2007
Aché’s Leading Products by Therapeutic Area, 2005
Aché & Biosintética’s Therapeutic/Product Areas, 2005
Biosintética’s Registrations & Marketing Authorisations of Generic Medicines, 2006
Aché’s & Biosintética’s Gross Revenues by Therapeutic Areas, 2005
Biosintética’s Sales, 2001-2004
Biosintética’s Pharmaceutical Sales by Therapeutic Areas, 2004
Americano’s Registrations & Marketing Authorisations of Generic Medicines, 2007
Erowlabs’ Registrations & Marketing Authorisations of Generic Medicines, 2007
Brainfarma’s Registrations & Marketing Authorisations of Generic Medicines, 2006
Cimed’s Registrations of Generic Medicines, January 2007
Cristália’s Business Units, 2006
Cristália’s Registrations & Marketing Authorisations of Generic Medicines, 2006
EMS’ Generics Registrations & Marketing Authorisations by Division, 2006
EMS’ Registrations & Marketing Authorisations of Generic Medicines, 2007
EMS’ Sales by Division, 2006
Eurofarma’s Generic Medicines, 2005
Eurofarma’s Pharmaceutical & Generic Sales, 2004-2007
Hipolabor’s Registrations & Marketing Authorisations of Generic Medicines, 2006
LAFEPE’s Product Lines, 2007
Medley’s Registrations & Marketing Authorisations of Generic Medicines, 2007
Medley’s International Agreements, 1992-2005
Neo Química’s Registrations & Marketing Authorisations of Generic Medicines, 2007
Prati, Donaduzzi’s Registrations & Marketing Authorisations of Generics, 2007
Teuto’s Registrations & Marketing Authorisations of Generic Medicines, 2007
U. Química’s Registrations & Marketing Authorisations of Generic Medicines, 2007
Abbott’s Registrations & Marketing Authorisations of Generic Medicines, 2007
Apotex’s Registrations & Marketing Authorisations of Generic Medicines, 2007
Mepha’s Registrations & Marketing Authorisations of Generic Medicines, 2006
Merck’s Registrations & Marketing Authorisations of Generic Medicines, 2007
Ranbaxy’s Presentations of Generic Medicines, 2007 .125
Novartis’ (Sandoz) Registrations & Marketing Authorisations of Generics, 2006
Sandoz’s (Hexal) Registrations & Marketing Authorisations of Generics, 2006
Key Data, 2007-2012
Registrations of Generic Medicines by Active Ingredient, January 2007
Marketing Authorisations of Generic Medicines by Active Ingredient, July 2006
List of Figures
Bioquivalent Studies, 2002-2005
Cumulative Active Ingredients, Registrations & Presentations of Generics, 2000-2006
Cumulative Registrations of Generic Medicines by Therapeutic Area, 2006 (%)
Registrations of Generic Medicines by Product Type, 2006
Registrations of Generic Medicines by Foreign Origin, 2006
Registrations of Generic Medicines by the 20 Leading Producers, 2006
Marketing Authorisations of Generic Medicines by Leading Producers, July 2006
Registrations & Marketing Authorisations of Generics by Leading Producers, 2006
Registrations & Marketing Authorisations of Generics by Leading Producers, 2006 (%)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (US$ Million)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (Million Units)
Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
Brazilian Pharmaceutical Market by Value, 1997-2006
Change in the Brazilian Pharmaceutical Market by Value & Volume, 1997-2006
Brazilian Pharmacy Sector by Value & Volume, 2003-2006
Pharmacy Sales of Generic Medicines by Value, 2000-2006
Pharmacy Sales of Generic Medicines by Volume, 2000-2006
Sales of Generic Medicines by Month as Percentage of the Pharmacy Sector, 2006
Generics & Total Pharmaceutical Market Projections, 2007-2012 (US$ Billion)
Pharmacy Sales of Oral Contraceptives & Hormones, 2006 (%)
Generics by Region as % of the Pharmacy Sector by Volume, Jan–June 2006
Generics Sales by Volume & Region, Jan–June 2006 (%)
Estimated Federal Pharmaceutical Expenditure, 2002-2007
Prescriptions of Generic Medicines, 2002-2006 (%)
Cost Savings by Using Generic Medicines, 2001-2006 (US$ Million)
Producers of Generic Pharmaceuticals in Goiás PharmaChemical Cluster, 2006
OPPORTUNITIES & CHALLENGES FOR GENERICS IN BRAZIL
R&D Investments in the Market of Generic Medicines by Type, 1999-2004 (%)
Aché’s Gross Revenues, 2001-2005 (US$ Million)
Biosintética’s Sales, 2001-2004
Cimed’s Sales, 2004-2007
Eurofarma’s Generics Sales as Percentage of Total Sales, 2004-2007
Ranbaxy’s Sales, 2003-2006
Sandoz’s Sales, 2003-2006
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