Natco's US partner Breckenridge files ANDA for everolimus

Breckenridge Pharmaceutical Inc (BPI), the US-based marketing partner of the Hyderabad-based Natco, has filed an abbreviated new drug application (ANDA) for Everolimus 0.25mg, 0.5mg, and 0.75mg tablets.
 
Novartis AG sells these tablets under the Zortress brand name in the US market. The drug is used to prevent organ rejection after a kidney or liver transplant. Zortress generated sales of $ 43.5 million for the 12-month period ending July 2014.
 
Natco and Breckenridge Pharmaceutical believe that its Paragraph IV ANDA was filed on the First-to-File date and expects to be the only generic that is entitled to the 180-day exclusivity period, Natco said in a BSE filing.