generic drug industry, bio generics, authorized generics, China, India, FDA-approved, patent protection, regulations

List Price: $750

 

A Guide to the Generic Drug Industry and Markets in the US

 

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GenericHandbook provides an in-depth, up-to-date analysis of the issues, trends, regulations, markets, companies and products in the U.S. generic drug industry. Topics covered include patent litigation, emerging competition from low-cost providers in China and India, authorized generic drugs, bio generic drugs, mergers and the impact of the NEW Obama Administration on the Drug Industry. 

 

Product & Market Section:

 

Five-year market forecast - Opportunity assessment for products losing patent protection 2009 - 2014 - Top 400 branded and generic products ( sales and growth rates) - Patent & exclusivity data for every FDA-approved product - Top 20 therapeutic categories - Total category sales - Share by company within therapeutic category and MORE...

 

Regulatory Section:

 

FDA structure and policies - Administrative actions and trends - Hatch-Waxman trends in case law - Paragraph IV challenges and success rates and MORE...

 

Company Section:

 

Senior Executive contact information - Company strategy & therapeutic focus - Formulation capabilities - Drug Master Files (DMF's) - Ownership (public vs. private) - Financial data (public companies) and MORE...

 

Publication Highlights:

 

• New FDA and FTC regulations
• Analysis of recent court decisions on authorized generics, recent out-of-court settlements and Paragraph IV challenges
• Biogeneric developments in Europe and US
• Analysis of emerging providers in India, China and Eastern Europe
• Up-to-date patent and exclusivity information
• Analysis of Wal-Mart's $4 Generic Program