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Home Industry News Orion faces patent challenge over Stalevo

Orion faces patent challenge over Stalevo

2nd January 2008

Orion Corporation has confirmed that it faces a new challenge by Indian generics firm Sun Pharmaceutical Industries over its proprietary drug Stalevo in the US.

Sun has amended its Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) with the view to gain authorisation to market and produce generic versions of Stalevo tablets in America.

In particular, Sun’s ANDA amendment contains a paragraph IV challenge to Orion’s patent number 5,446,194.

Orion has stated that the ANDA review process is in its early stages and the possibility of generic competition is not a certainty.

In November 2007, Orion sued Sun for patent infringement after the Indian pharmaceutical firm filed a paragraph IV against Orion’s patents 6,500,867 and 6,797,732 for Stalevo.

Overall, Orion has six patents listed in the FDA’s Orange Book with three not receiving paragraph IV certifications from Sun.

Stalevo is an enhanced levodopa treatment originated by Orion and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson’s disease.

This month sees Timo Lappalainen succeed Jukka Viinanen as president, chief executive officer and chairman of the executive management board of Orion.

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