Ranbaxy is to receive an USFDA approval for validation for a particular drug on Monday, March 25 after which it would forfeit opportunities to develop the drug going forward, reports CNBC-TV18's Ekta Batra.
However, little is known about the drug. It is code-named ANDA 3 and apparently carries a 180-day exclusivity on it. The drug could range from being very small or similar to Diovan Generic which addresses hypertension.
Ranbaxy had exclusivity on Diovan Generic which expired in September 2012 and has not received USFDA approval for it ever since. Though Ranbaxy’s exclusivity ended on March 21, no other generic participant has received approval for Diovan Generic.
So, pharma industry experts estimate that the deadline of March 25 date could be applicable to Diovan Generic and Ranbaxy’s 180-day exclusivity could possibly start from that date.