Mylan settles suit over asthma, allergy drug

Generic drug maker reaches settlement with Shionogi, Cima Labs

PITTSBURGH — Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said.

The generic drug maker said it resolved a patent litigation suit filed by Shionogi and Cima Labs over prednisolone sodium phosphate orally disintegrating tablets, a generic version of Orapred ODT. Mylan is hoping to market its generic version of the drug in the 10-mg, 15-mg and 30-mg strengths. The drug is used to treat asthma and certain allergic conditions.

Under the settlement, Mylan will be able to launch its product starting in April 2014. The company said it was likely the first company to file a regulatory approval application containing a Paragraph IV certification, a legal assertion that the patent covering the branded drug is invalid, unenforceable or not at risk of being infringed.

Orapred ODT had sales of $33.1 million during the 12-month period ended in June, according to IMS Health.


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