Natco files marketing exclusivity application for cancer drug sorafenib
Sorafenib tablet, which is the generic version of Nexavar (marketed by Bayer and Onyx Pharmaceuticals, had recorded sales of approximately $48 mn in the US in 2014
BS B2B Bureau B2B Connect | Hyderabad
“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,” said Natco in a press release.
Nexavar tablets - marketed by Bayer Healthcare, Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals – had recorded sales of approximately $48 million for the 12 months ending December 31, 2014 in the US, according to IMS Health.
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First Published: Feb 12 2015 | 3:49 PM IST