Natco Pharma's partner Mylan files application for Sorafenib with the USFDA

The company hopes to be eligible for 180 days marketing exclusivity upon receiving the approval

Hyderabad-based Natco Pharma Limited, which was granted compulsory licence for Bayer’s cancer drug Nexavar (Sorafenib) by the Indian patent office a couple of years ago, today announced that its marketing partner Mylan Inc has filed an abbreviated new drug application (ANDA) for the generic version of the same with the US Federal Drug Administration (US FDA).

The company also said it hoped to be eligible for 180 days marketing exclusivity upon receiving the final FDA approval to manufacture and market in the US as it believed to be the first to have filed a substantially complete ANDA containing a Paragraph IV certification.

The first-to-file opportunity in the US market usually gives handsome revenues from the sale of the product during the six months of exclusivity period before other generic drug players introduce their versions in the market.

Natco announcement comes a day after Mylan Inc reportedly confirmed that its subsidiary Mylan Pharmaceuticals had been sued by Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc and Onyx Pharmaceuticals Inc in connection with the filing of the application.

Bayer and its associates sell Sorafenib tablets under the brand name Nexavar in the US market and for the 12 months ending December, 2014, its sales stood at around $48 million according to IMS Health.

The homegrown  company had hit headlines in March, 2012, when it had received the first-ever compulsory licence for Sorafenib as it had sought to sell the generic version of the drug at Rs 8,880 for a pack of 120 tablets equivalent to one month therapy as compared with Rs 284,428 for a similar pack of tablets sold by the patent holder at that point.

The product is indicated for the treatment of certain types of cancers including primary kidney and liver cancer.