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Mylan can launch authorized generic Parkinson's drug under settlement

Mylan, Orion settle Stalevo lawsuit

PITTSBURGH — Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease, Mylan said Thursday.

The generic drug maker had filed with the Food and Drug Administration for a generic version of Orion's Stalevo (carpidopa; levodopa; entacapone) tablets, used to treat idiopathic Parkinson's to substitute for immediate-release carbidopa/levodopa and entacapone administered separately.

Under the agreement, Mylan can immediately launch an authorized generic version of Stalevo and then launch its own generic after the FDA approves it. An authorized generic is the original branded drug marketed under its generic name at a discount, usually through a third-party company. Mylan is seeking approval for the drug in the 12.5-mg/50-mg/200-mg, 18.75-mg/75-mg/200-mg, 25-mg/100-mg/200-mg, 31.25-mg/125-mg/200-mg, 37.5-mg/150-mg/200-mg and 50-mg/200-mg/200-mg strengths.

Stalevo had sales of about $138.6 million during the 12-month period that ended in March, according to IMS Health.


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