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GenericHandbook - A Guide to the Generic Drug Industry in the US
VOI Consulting, Inc., March 2009, Pages: 500


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The industry's most comprehensive source on the generic durg industry in the US.

Coverage includes sections:

- Products / Market
- Regulatory
- Top company profiles

TOPICS COVERED INCLUDE:

- Impact of the NEW Obama Administration on the Generic Drug Industry
- Analysis of recent Patent Litigation effecting the Generic Drug Industry
- Medicare and Medicaid pricing policies
- Intellectual property status and expirations dates for all branded drug products
- Emerging competition in India,China and Eastern Europe
- Recent Mergers and Aquistions
- Impact of Bio generics

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


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