Innovator Pfizer has sued generic player Kremer-Urbans LLC and its partner KUDCO for filing ANDA with Para IV certification against Orange Book listed patent for Atorvastatin (Lipitor) tablets in the U.S. District Court for the District of Delaware
Innovator has asserted following polymorph patent against generic player:
US5969156 (Expiry: June 8th, 2017): Which covers various hydrated Polymorphs of Atorvastatin (Form I, II and IV)
As per complaint filed in the U.S. District Court for the District of Delaware, innovator has requested court to block generic version till the expiry of crystalline polymorphic form patent.
The other Para IV filers on this product are Teva, Cobalt, Apotex, Matrix (Mylan), Dr. Reddy and Kremer-Urbans LLC and KUDCO
Earlier, Ranbaxy (First para IV filer) had settled its pending patent litigation on Lipitor and Caudet on June 18, 2008 and will launch its generic product in November, 2011
No comments:
Post a Comment