Natco Pharma Limited 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.
Fingolimod is an immunomodulating drug and Cabazitaxel is a microtubule inhibitor, and the fourth taxane to be approved as a cancer therapy.
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 US$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 US$116.8 Million for twelve months ending September 2014,according to IMS Health.
