Sun Pharma, Orion settle litigation over generic Stalevo and Comtan

22 Jun 2010

1

Sun Pharmaceutical Industries Ltd and its affiliates have settled a lawsuit filed by Orion in the United States against Sun Pharma over its abbreviated new drug applications (ANDAs) for generic versions of Orion's Stalevo and Comtan tablets.

Under the terms of the settlement, Sun Pharma will be able to launch generic versions of 25/100/200 mg and 37.5/150/200 mg strengths of Stalevo tablets in the US on 1 April 2012.

In addition to these, Sun Pharma will be able to launch generic versions of other dosages of Stalevo on 2 October 2012 and generic versions of Comtan on 1 April 2013, unless certain conditions relating to launch are fulfilled even earlier, Sun Pharma said in a release.

Under the agreement, Orion will supply these generic product versions to Sun Pharma. Sun did not reveal other terms of the settlement, but said the agreements will be subject to review by the US Federal Trade Commission and the US Department of Justice.

Stalevo and Comtan are registered trademarks of Orion Corporation.

India-based Sun Pharmaceutical Industries is an international, integrated, speciality pharmaceutical company, manufacturing and marketing various pharmaceutical formulations as branded generics as well as generics in India, the US and several other markets across the world.

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