Natco Pharma, one of the few Indian companies to venture into new drug discovery research, announced that its marketing partner in the USA, Mylan 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 U.S. Food and Drug Administration (US FDA). 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 U.S. upon final FDA approval. 

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

Shares of the company gained Rs 57.55, or 4.79%, to trade at Rs 1,260. The total volume of shares traded was 1,903 at the BSE (9.34 a.m., Monday).