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
List of 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
List of 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