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Hyderabad-based Natco Pharma Limited stated that it had received tentative approval of Oseltamivir Phosphate capsules 30 mg (base), 45 mg (base) and 75 mg (base) by the United States Food & Drug Administration (USFDA). Natco is partnered with Alvogen for marketing.
Natco may have First to File approval status for the abbreviated new drug application (ANDA), contingent upon successful litigation outcome of original drug patent, the company said in a press release on Tuesday.
Tamiflu (Roche's trade name for Oseltamivir Phosphate) had US sales of approximately $495 Million for twelve months ending September 2013, according to IMS Health.
Natco has challenged the patent for Tamiflu - a drug to treat bird flu - in the US.
The company's shares were trading at Rs 833.90 on BSE, up 1.19% over the previous close of Rs 824.10.
