Dr Reddy’s loses amlodipine maleate patent dispute with Pfizer

EPP News Bureau - Mumbai

HYDERABAD-based Dr Reddy’s Laboratories (DRL) has announced that a US Appeals Court has reversed a lower court ruling and determined that the patent extension covering Pfizer’s Norvasc (amlodipine besylate) is applicable to Dr Reddy’s amlodipine maleate. This restrains the Indian company from introducing its amlodipine maleate in the American hypertension drugs market, where Pfizer’s second largest selling drug claims an annual sales well over US dollar two billion.

DRL had also filed an abbreviated new drug application (ANDA) recently, seeking marketing approval for the generic version of Norvasc, which has also triggered a patent infringement suit from Pfizer, which is subjudice.

A company spokesperson told Express Pharma Pulse that DRL is targeting US dollar 22 billion in the short term from 31 ANDA approvals and another new drug application, which he declined to identify for competitive reasons.

The US Court of Appeals for the Federal Circuit ruling held the lower court had “misconstrued” a provision of the Hatch Waxman Act which Pfizer owes for the patent term extension on Norvasc, said a statement from Pfizer, issued in New York.

GV Prasad, CEO of Dr Reddy’s Laboratories, said in a company statement that despite the setback, the company remains committed to investing resources to create a sustainable US-based business of specialty products and new chemical entities as well as generic medicines.