Natco files ANDA applications for cancer and multiple sclerosis drugs in US

Natco Pharma Limited has filed Abbreviated New Drug Applications (ANDAs) for fingolimod 0.5mg capsules & cabazitaxel 60mg/1.5ml injection, with the US Federal Drug Administration (USFDA), through its respective marketing partners in the US. While fingolimod (a generic version of Novartis’ Gilenya) is used for the treatment of certain patients with multiple sclerosis, cabazitaxel (a copycat of Sanofi’s Jevtana) is recommended for treating certain patients with hormone-refractory prostate cancer.
 
“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 capsules & cabazitaxel injection, providing 180 days of marketing exclusivity upon its final USFDA approval,” said Natco in a BSE filing.
 
According to IMS Health, for twelve months ending September 2014, Gilenya and Jevtana had market size of $1.2 billion and $116.8 million, respectively, in the US.