US Generics Market Overview - Generic Opportunities are Expected to Peak in 2012

DALLAS, December 19, 2011 /PRNewswire/ --

ReportsnReports adds new market research report 'US Generics Overview' to its store. This research report gives an overview of the US generics market & key trends in the US generic industry.

Features and benefits

• Analysis of top-line trends in the US generics market
• Identification of opportunities for growth as the number of expiries available for genericization begins to slow

Your key questions answered

• See how the US generics market is at a turning point as the number of brands available for genericization begins to slow
• Assess how companies are maintaining growth by targeting niches within the US generics market

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Table of Contents:

EXECUTIVE SUMMARY

US GENERICS MARKET OVERVIEW

• Total US prescription pharmaceutical market
• Levers on the outlook for US generic drug sales
• Generic approvals are set to slow, but significant opportunities remain

NDA filing trends indicate a coming slowdown in first ANDA approvals

Existing NDAs are still to yield a high number of generic products

Generic drug companies have become more effective at taking opportunities

Time to genericization

• Generic opportunities are expected to peak in 2012

SPECIALIZED MARKET SEGMENTS

• Key findings
• Specialized generics segments reduce levels of competition
• Strong competitive positioning drives success
• Half of all oral immediate-release formulations have been genericized

Formulation type impacts the level of competition faced

Injectables capabilities can be leveraged for biosimilars development

Generics require limited therapy area expertise

Genericization levels impact the outlook for different ATC classes

New entrants threaten dominant players in the oral contraceptives space

LEGISLATIVE DEVELOPMENTS

• Key findings
• Pay-for-delay settlements expected to be banned in the US in 2012
• Authorized generics ban is not expected to pass following the FTC's review
• Changes to "parked exclusivities" could result in significantly earlier generic launches

APPENDIX

• References

Journal papers

Websites

Datamonitor publications

• Abbreviations
• Exchange rates

TABLES

• Table: Top 25 brands for which Paragraph IV-certified ANDAs have not yet been filed with the FDA, 2011
• Table: Top 25 brands for which Paragraph IV-certified ANDAs have been received, 2011
• Table: Therapy area abbreviations
• Table: Exchange rates, 2011

FIGURES

• Figure: The PharmaVitae Explorer
• Figure: Total US small molecule and biologic prescription pharmaceutical sales, 2001-10
• Figure: Total US small molecule generic drug sales and year-on-year growth rate, 2001-10
• Figure: Levers on the outlook for US generic drug sales
• Figure: Breakdown of FDA approvals, 1991-2011
• Figure: RLD NDAs, by ANDA approval status, 1940-2011
• Figure: RLD NDAs, by ANDA approval status (% of total per year), 1940-2011
• Figure: Proportion of total RLD NDAs with associated final approved ANDAs, 1990-2011
• Figure: Breakdown of RLD NDAs in Q3 2011
• Figure: Age of corresponding NDA for first ANDA approvals, 1997-2011
• Figure: Generic opportunities, by last full unexpired year of US branded small molecule sales, 2002-16
• Figure: Specialized segments within generics markets
• Figure: Competitive positioning in generics markets
• Figure: Proportion of genericized brands, by formulation type
• Figure: Average number of final approved ANDAs per genericized RLD NDA
• Figure: Top 20 companies in US generic injectables, by number of approved ANDAs
• Figure: Proportion of genericized brands, by therapy area
• Figure: Breakdown of therapy areas by ATC2 class size and genericization level
• Figure: Breakdown of therapy areas by ATC2 class sales, growth rate, and genericization level
• Figure: Ranking by number of oral contraceptive ANDA and NDA approvals
• Figure: S.27: Kohl's Preserve Access to Affordable Generics Act
• Figure: S.373: Rockefeller's Fair Prescription Drug Competition Act
• Figure: S.1882: Bingaman's Fair and Immediate Release of Generic Drugs Act

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