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Published on 27 April 2012

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Orion files patent infringement over Stalevo

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Orion Corporation has filed a patent infringement lawsuit in the United States to enforce Orion’s U.S. patents No. 5,446,194, No. 6,500,867 and No. 6,797,732 covering Orion’s product Stalevo® against Mylan Pharmaceuticals Inc. (Mylan).

Mylan seeks authorisation to produce and market generic tablets (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) in the United States, with carbidopa, levodopa and entacapone as active ingredients in the same proportion as in Orion’s Stalevo®.

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

At this point, the Abbreviated New Drug Application (ANDA) review process is just beginning in the United States and generic competition is not imminent based on this application.

As reported on 26 March 2012, Orion Corporation was notified that Mylan submitted an ANDA with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge to the above mentioned patents.

By suing to enforce its patent within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation is entitled to an automatic stay prohibiting the FDA from approving the applicant’s ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation’s above mentioned patents in the infringement lawsuit.

As such, the realisation of generic competition is not imminent based on this application.

Orion Corporation will defend the intellectual property rights covering Stalevo.

Orion Corporation



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