Multinational pharma giant Pfizer Inc has filed a suit against Dr Reddy's Laboratories in the Federal Court, New Jersey, for alleged patent infringement with regard to a Paragraph-IV filing made by the latter on an Orange Book patents listed for Norvasc, the branded version of amlodipine besylate.
Dr Reddy's, during the last quarter of the fiscal 2001-02, filed Paragraph-IV certifications on the two Orange Book Patents listed for Norvasc as a new drug application (NDA) for amlodipine maleate under Section 505 (b) (2) of the Federal Food, Drug and Cosmetic Act (FFDC Act).
Pfizer notified that it had filed a suit against Dr Reddy's on one of the two Orange Book patents, the 4572 909 patent which expires in July 2006. However, Pfizer did not file a suit on the second patent, 4879 303 which is slated for expiry in March 2007.
Dr Reddy's is the first Indian company to file such application under Section (b) (2) of the FFDC Act.