Drug maker Natco Pharma Ltd today said its marketing partner in the US Breckenridge Pharmaceutical Inc (BPI) has filed an Abbreviated New Drug Application (ANDA) for Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets.
"Natco and BPI 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," city-based Natco said in a filing with bourses.
Novartis AG sells Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets under Brand name Zortress in the USA market.
The drug which is used to prevent organ rejection after a kidney or liver transplant, generated sales of $43.5 million for the twelve-month period ending July 2014, based on industry sales data, Natco said.
Shares of Natco today closed higher by 5 per cent at Rs 1,438.60 on the BSE.