Mylan's generic Entocort EC to enter market

PITTSBURGH — A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.

Mylan said the U.S. District Court for the District of Delaware ruled that Mylan’s regulatory approval application for budesonide capsules in the 3-mg strength does not violate the patent for the branded drug, AstraZeneca’s Entocort EC.

The Food and Drug Administration approved Mylan’s product last month, and the company said it plans to launch immediately. Budesonide capsules in the 3-mg strength had sales of about $350 million for the 12 months ended in March, according to IMS Health.

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