Natco Pharma gets final approval for Tamiflu capsules in the US

The company filed ANDA, containing a para IV certification, claiming first to file status in 2011 and was granted tentative approval by USFDA in March 2014

Hyderabad-based Natco Pharma has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of generic versions of Tamiflu oral capsules, 30 mg, 45 mg and 75 mg.

The company filed the ANDA, containing a para IV certification, claiming the first to file status in the year 2011 and was granted tentative approval by the US drug regulator in March 2014. Used in treatment of influenza type A and B (bird and swine flu), Tamiflu (Oseltamivir phosphate) drug is owned by US-based Gilead Sciences along with its patent partner Roch Holding.

Earlier in December 2015, Natco and its US partner Alvogen settled a patent infringement case with Gilead, Hoffman-La Roch and their subsidiary companies. Under the terms of the settlement, Natco's partner will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period listed in FDA's Orange Book for the said patent, which is February 23, 2017, according to Natco.

 

Tamiflu oral capsules had US sales of approximately $403 million for twelve months ended December 2015, the company stated, citing IMS Health data. If granted exclusivity, Natco's partner will be entitled to 180 days of exclusive right to sell the generic version of oseltamivir.