generichandbook™ - Guide to US Generic Drug Industry

Generic Market Section

INCLUDES: Generic pricing and margin structure - Five-year market forecasts - Opportunity assessment for products losing patent protection - PBM, GPO, and pharmacy analytics - Wholesaler environment - Customer attitudes - Payer policies for oral and injectable drugs - Emerging market suppliers and MORE...

Legal & Regulatory Section

INCLUDES: FDA structure and policies - Administrative actions and trends - Hatch-Waxman trends in case law - Paragraph IV challenges and success rates - At-risk launches - ANDA approval procedures, probabilities, and timelines - 505(b)(2) developments - Biosimilar policies - Implications of court rulings, FTC and FDA policies on reverse payments, authorized generics AND MORE...

Product & Company Section

INCLUDES: Top 400 branded and generic products sales and growth rates - Patent & exclusivity data for every FDA-approved product - Sales and trends by therapeutic category - Share by company within therapeutic category -Senior Executive contact information - Company strategy & therapeutic focus - Formulation capabilities - Drug Master Files (DMF's) - Ownership - Financial data - M&A activity and MORE...

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