Dr Reddy's Laboratories announced today that the oral argument of its motion to dismiss Pfizer's complaint in the Amlodipine Maleate case was heard on Wednesday, December 11, in the District Court of New Jersey, USA. The court gave no decision but indicated that it intended to issue an opinion on December 17, according to a press release issued by Dr Reddy's in Hyderabad.
Dr Reddy's statement said it had 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. However, Pfizer did not file a suit on the second patent. Subsequently, Dr Reddy's filed a motion to dismiss Pfizer's complaint, the argument for which was heard on December 11.
In October 2002, the US 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 the ongoing discussions with the FDA regarding issues relating to specific chemistry manufacturing controls and product labelling. Final approval is also contingent upon a successful outcome in the patent term extension litigation with Pfizer.
Amlodipine Besylate is the generic version of Pfizer's Norvasc and is indicated for the treatment of hypertension and angina.