Natco Pharma Ltd.

Natco Pharma’s marketing partner in the USA, Mylan Inc., has filed an Abbreviated New Drug Application (ANDA) for a three-times-a-week generic COPAXONE (glatiramer acetate injection, 40 mg/mL) and has been accepted by the US Food and Drug Administration (USFDA). COPAXONE is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Natco’s partner Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.

In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva. According to IMS Health, Copaxone 40 mg/mL had US sales of approximately $411.5 million for the 12 months ending June 30, 2014.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.