Natco’s US marketing partner files ANDA for ‘Copaxone’

01 Sep 2014 Evaluate

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.

Natco Pharma Share Price

895.90 -12.20 (-1.34%)
29-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1717.50
Dr. Reddys Lab 1268.60
Cipla 1494.40
Zydus Lifesciences 904.00
Lupin 2079.50
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×