Natco Pharma, one of the few Indian companies to venture into new drug discovery research, announced today that it has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, with the U.S. Federal Drug Administration (USFDA), through its respective marketing partners in the USA.

Natco & its associated marketing partners for the above products in the USA, believe that they are the first company to have filed a substantially complete ANDA which includes a paragraph IV certification for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, providing 180 days of marketing exclusivity upon its final USFDA approval.

Novartis sells Fingolimod 0.5mg Capsules under Brand name Gilenya, in the USA market and used for the treatment of certain patients with multiple sclerosis. The market size of Gilenya in the USA is approximately USD 1.2 billion for twelve months ending September 2014, according to IMS Health.

Sanofi sells Cabazitaxel 60mg/1.5ml Injection under Brand name Jevtana, in the USA market and used for the treatment of certain patients with hormone-refractory prostate cancer. The market size of Jevtana® in the USA is approximately USD 116.8 million for twelve months ending September 2014, according to IMS Health.

Shares of the company gained Rs 74.65, or 5.49%, to settle at Rs 1,434.15. The total volume of shares traded was 15,620 at the BSE (Tuesday).