Movers and shakers in the US generics industry
Which companies are beginning to make their mark on the US generics market, either with their finished dose products or active ingredients?
The latest Movers & Shakers report from Thomson Reuters looks at companies beginning to make their mark on the US generics market, either with their finished dose products or active ingredients, and analyzes trends and statistics relating to the market as a whole. The report focuses on activities during October to December 2009.
Key highlights include:
ANDA Approvals
Companies from 15 countries received a total of 448 ANDA approvals in 2009, down only slightly from 463 approvals in the previous year. US companies received 151 approvals, more than any other country, followed closely by Indian companies with 139 approvals.
During fourth quarter 2009, Japan's Daiichi Sankyo, which owns Ranbaxy (India), received seven ANDA approvals, earning it top ranking. US based Amneal Pharmaceuticals with six approvals was in second place.
Paragraph IV Challenges
Patent challenges were on the rise in 2009. 61 molecules or combinations endured Paragraph IV patent challenges, nearly double the 33 challenges in 2008 and far above the 39 in 2007.
Products facing challenges in 2009 included blockbusters such as:
- Docetaxel anhydrous, Sanofi-Aventis' antineoplastic product marketed in the U.S. as Taxotere®
- Efavirenz, the anti-HIV product marketed in the U.S. by Bristol-Myers as Sustiva®
- Pregabalin, marketed in the U.S. by Pfizer under the Lyrica® name
Teva remains by far the most prolific filer of ANDAs that include patent challenges. We linked the company to challenges on 146 products, up from 140 the quarter before. Novartis (Sandoz) replaced Mylan in second place with links to patent challenges on 73 products.
Notable deals and game changing plays
During the fourth quarter of last year the following companies were involved in deals in the generic space: Hospira; Watson Pharmaceuticals; GlaxoSmithKline and Pfizer. Based on our research of ANDA filings and Paragraph IV challenges, the following companies made some game-changing plays in the US generics industry: Hisamitsu Pharmaceutical Inc; Pharmaforce Inc. and Claris Lifesciences Limited.
About Movers & Shakers
The Thomson Reuters quarterly report on the US generics industry uses strategic intelligence and competitive analysis information from Newport Premium, the critical product targeting and global business development system from the industry authority on the global generics market.