Indian drug manufacturer Natco Pharma has filed an abbreviated new drug application (ANDA) with the FDA for a generic version of Tamiflu (oseltamivir), challenging Gilead Science’s patent protection on the drug.
Generics to cash in on swine flu epidemic
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Posted 11/03/2011
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Natco announced that the FDA had accepted its ANDA for the generic version of oseltamivir phosphate capsules, which are used in the treatment of bird and swine flu infections, on 9 February 2011.
This could be a major coup for Natco, especially if the company gains 180 days of generic market exclusivity as the first to file, since global annual sales of Tamiflu are estimated to be in the region of US$1 billion (Euros 72.5 million).
Natco has made an agreement with the Luxembourg based Alvogen Inc for marketing and sales of oseltamivir phosphate in the US.
Source: Natco
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