Dr. Reddy's Laboratories has announced that the United States District Court for the District of New Jersey on December 17, 2002 had dismissed Pfizer's complaint on the grounds that the patent term extension does not cover Dr Reddy's amlodipine maleate product.
The Company expects to launch the product in August 2003, upon expiration of Pfizer's pediatric exclusivity and receipt of a final US FDA approval for the Company's NDA.
G V Prasad, CEO of Dr Reddy's said: "The favorable court ruling represents a significant milestone in the execution of our US specialty business strategy. Our key priority is to create an exciting and sustainable pipeline of specialty products and the commercial front end to take these products to market. The specialty business will be a vital link in our transition from a diversified generic pharmaceutical company to a discovery-led global pharmaceutical company."
Dr. Reddy's filed a New Drug Application (NDA) for amlodipine maleate under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act in December 2001. The Company had filed a Paragraph IV Certification on the two Orange Book patents listed for Pfizer's Norvasc - the '909 and '303 patents.
On June 17, 2002, Pfizer notified Dr. Reddy's that it had filed a suit in the Federal Court in New Jersey on one of the two Orange Book patents, the '909 patent. Pfizer did not file a suit on the second patent. Subsequently, Dr Reddy's filed a motion to dismiss Pfizer's complaint, which was decided on December 17, 2002.
In October 2002, the U.S. Food and Drug Administration (FDA) had determined the NDA submitted by the Company for amlodipine maleate as "Approvable". Final approval of the NDA is contingent upon the successful completion of ongoing discussions with the FDA regarding issues relating to specific chemistry manufacturing controls and product labeling.
Pfizer's Norvasc (amlodipine besylate) is indicated for the treatment of hypertension and angina.