Unravel the Most Significant Game-Play in the Generics Market
Read the latest edition of the Movers and Shakers report
The latest edition of the Pharma Matters report, Movers and Shakers, is now available. The report features major developments in the US generic industry during the fourth quarter of 2012, including the Generic Drug User Fee Act (GDUFA).
Additional highlights include:
- 45 companies from 9 countries received a total of 106 final ANDA approvals. US-based groups received the most approvals, with 45 approvals granted among 18 corporate groups. India-based companies were close behind, with 20 corporate groups receiving a total of 44 approvals.
- The FDA posted information on first Paragraph IV patent challenges to only 3 new active ingredients or combinations.
- More than 40 new Paragraph IV patent infringement lawsuits were filed in Q4, concerning 24 different compounds or combinations.