Table of Contents
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
- 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
- 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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