Amneal Pharma beats Dr Reddy's in launching limited-competition drug

US-based Amneal Pharmaceuticals beat Dr Reddy’s Laboratories (DRL) in getting approval from the US Food and Drug Administration (USFDA) for a key limited-competition drug that the Hyderabad company has been working on. 

DRL’s shares on Friday fell as much as 3.3 per cent intra-day, ending the day at Rs 2,827 apiece, down 2.7 per cent. Amneal Pharma, promoted by two Indian-American brothers, got the USFDA approval for generic NuvaRing, a drug used to prevent pregnancy. Merck’s NuvaRing has an estimated market size of $880 million, and is clocking single-digit growth. Some analysts peg the size at over $950 million. 

Amneal’s EluRyng is the first generic version of this low competition drug, which the company plans to launch this month. Amneal will have very limited competition for months now. Apart from DRL, Teva Pharma and Mayne Pharma are in the race to launch the drug.  In August, DRL got a complete response letter (CRL) from the USFDA on this drug. A CRL is issued when the FDA decides not to approve new or generic drug application for marketing in its present form. DRL is yet to respond to the USFDA on the matter.