Zydus receives marketing exclusivity approval for Sirolimus tablets

The Ahmedabad-based Zydus Cadila received the final approval from the US FDA to market Sirolimus tablets 0.5 mg with 180 days of marketing exclusivity. As per IMS data in 2013, the sales of Sirolimus 0.5 mg was estimated at $11.7 million and the total market for Sirolimus was approximately $ 203.8 million.
 
The group also received Duloxetine delayed release capsules in different strengths of 20 mg, 30 mg and 60 mg. The sales for Duloxetine was estimated at $5.5 billion in 2013.
 
While Sirolimus tablets are immunosuppressant drugs used to prevent rejection in organ transplantation, Duloxetine delayed release capsules fall in the anti-depressants segment.
 
The group now has 86 approvals and has so far filed 216 ANDAs since the commencement of filing process in FY 2003-04.