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Natco Pharma Limited has filed abbreviated new drug applications (ANDAs) for Fingolimod, 05 mg capsules, and Cabazitaxel, 60 mg/1.5ml injection, with the US Federal Drug Administration (USFDA) through its respective marketing partners in the US.
Natco Pharma said they were the first company to have filed a substantially complete ANDA, which include a paragraph IV certification for these products, providing 180 days marketing exclusivity upon its final US FDA approval.
Novartis sells Fingolimod 0.5 mg capsules under the brand name Gilenya in the US market. The drug is used for the treatment of patients with multiple sclerosis. The market size of Gilenya in the US stood at around $1.2 billion for 12 months ending September 2014.
Sanofi sells Cabazitaxel injection under the brand name Jevtana. It is used for treatment of patients with hormone-refractory prostate cancer. Its market size in the US was around $ 116.8 million during the same period, according a Natco release.
