Launch, however, subject to approval of US Food and Drug Administration
New Delhi: Hyderabad-based drug maker Natco Pharma said a US court of appeals for the federal circuit ruling had paved the way for it to launch the generic Copaxone through its marketing partner Mylan during May 2014.
The launch is, however, subject to the approval of the US Food and Drug Administration. Natco said in Hyderabad on Saturday the US court had reversed a district court’s finding related to Teva’s US patent for Copaxone.
This means it may launch generic version of the drug. Copaxone (glatiramer acetate) is used in the treatment of relapsing-remitting multiple sclerosis. The product is estimated to have had sales in the US of $3.45 billion during 2012.
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