Natco Pharma announced today that its marketing partner, Mylan, has filed an Abbreviated New Drug Application (ANDA) for Sorafenib tablets, 200mg, with the US Federal Drug Administration (USFDA).

This product is the generic version of NEXAVAR, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma. Natco and its marketing partner believe that they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.

Bayer Healthcare, Bayer Healthcare Pharmaceuticals, and Onyx Pharmaceuticals, sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR, in the USA market. For the 12 months ending Dec. 31, 2014, NEXAVAR had US sales of approximately USD 48 million, according to IMS Health.

Shares of the company declined Rs 3.15, or 0.22%, to settle at Rs 1,431. The total volume of shares traded was 12,914 at the BSE (Wednesday).