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Published on 26 July 2013

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Orion and Mylan settle patent dispute over Stalevo®

Orion Corporation (“Orion”) and Mylan Pharmaceuticals Inc. (“Mylan”) have executed a settlement and license agreement to settle the lawsuit filed by Orion in the United States against Mylan regarding Mylan’s submission of an abbreviated new drug application (“ANDA”) for generic versions of Orion’s Stalevo® (carbidopa/levodopa/entacapone) product.
The lawsuit was filed by Orion in the U.S. in April 2012.

Orion Corporation (“Orion”) and Mylan Pharmaceuticals Inc. (“Mylan”) have executed a settlement and license agreement to settle the lawsuit filed by Orion in the United States against Mylan regarding Mylan’s submission of an abbreviated new drug application (“ANDA”) for generic versions of Orion’s Stalevo® (carbidopa/levodopa/entacapone) product.
The lawsuit was filed by Orion in the U.S. in April 2012. Under the terms of the settlement and license agreement, Mylan shall be authorised to launch generic versions of the Stalevo product (strengths 12.5/50/200 mg; 18.75/75/200 mg; 25/100/200 mg; 31.25/125/200 mg; 37.5/150/200 mg and 50/200/200 mg) immediately after entry of the agreement.
Subject to the Court’s approval, the lawsuit against Mylan will be dismissed and the US Patents Nos. 5,446,194, 6,500,867 and 6,797,732 shall remain in force.
In compliance with the applicable US laws, Orion will file the above agreement with the United States Federal Trade Commission and the United States Department of Justice.


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