Natco Pharma loses US case on generic Copaxone

25 Jun 2012 Evaluate

The US District Court for the Southern District of New York has upheld the contention of Teva Pharmaceuticals that NATCO Pharma’s abbreviated new drug application (ANDA) for the generic version of Copaxone infringes all the asserted claims of Teva Pharmaceuticals.

Earlier in June 2008, Natco has filed, with its partner Mylan Inc. an ANDA seeking approval for marketing of the generic version of the relapsing, remitting multiple sclerosis drug Copaxone and obtained a Para IV certification which essentially challenges the existing patents held by Teva Pharmaceuticals.

Natco is disappointed with the Court’s decision. While the company has not yet had the opportunity to review the Court’s opinion, it will fully investigate all available options for appeal once the Court's full opinion becomes available.

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. The company began its operations in 1984 in Andhra Pradesh.

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