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Wockhardt will launch a generic version of Comtan tablets, used in treating Parkinson’s disease, in the US with 180 days of marketing exclusivity.
Wockhardt has received the US Food and Drug Administration (USFDA) approval for marketing a generic version of 200mg tablets containing Entacapone, which is used in the treatment of Parkinson’s disease, the Mumbai-based firm said in a statement today.
“Pursuant to a settlement of the litigation between Wockhardt and Orion Corporation, Finland, the holder of the NDA, Wockhardt will launch an authorised generic version from September 30, 2012, with 180 days of exclusivity,” Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.
Wockhardt was the first-to-file with paragraph-IV certification on this product, he added.
Entacapone tablet is the generic name for the brand Comtan, owned by Orion Corporation and marketed in the US by Novartis.
Wockhardt will launch the product in the US market on September 30, 2012, the company said. According to IMS Health data, the total market for Entacapone tablets in the US is about $98 million.
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