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Natco Pharma Ltd has filed Abbreviated New Drug Applications (ANDAs) for fingolimod capsules and cabazitaxel injection with the US Federal Drug Administration (USFDA).
The filing was done through its respective marketing partners in the US, the company informed the Bombay Stock Exchange.
Fingolimod is a generic version of Novartis’ Gilenya and is used for the treatment of certain patients with multiple sclerosis. Cabazitaxel, a generic of Sanofi’s Jevtana, is indicated for the treatment of hormone-refractory prostate cancer. Once approved, the company expects to get 180 days of marketing exclusivity for these products.
According to IMS Health, for 12 months ended September 2014, Gilenya and Jevtana had a market size of $1.2 billion and $116.8 million, respectively, in the US.
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