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news.Sun Pharmaceutical Industries and its affiliates have accomplished a settlement agreement with Orion demanding a dismissal of the lawsuits filed in the US against Sun Pharma’s submission of abbreviated new drug applications (ANDAs) for generic versions of Stalevo and Comtan tablets.
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Sun Pharma said that, as per the terms of the settlement agreement, it is expected to be able to launch generic versions of 25mg/100mg/200mg and 37.5mg/150mg/200mg strengths of Stalevo tablets in the US on April 1, 2012.
Additional to these strengths, Sun Pharma is also expected to be able to launch generic versions of other strengths of Stalevo product and Comtan product on October 2, 2012 and April 1, 2013, respectively, unless certain conditions relating to launch are fulfilled even earlier. The parties have agreed that Orion will supply these generic product versions to Sun Pharma.
Sun Pharma and Orion stated that these agreements will be subject to review by the US Federal Trade Commission and the US Department of Justice.