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Mylan granted license to market generic menopause drug

Generic estradiol patch set to launch in December 2013

PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.

The Pittsburgh-based generic drug maker was the first to file for regulatory approval of the drug with the Food and Drug Administration, and as such, will be entitled to 180 days of market exclusivity in which to compete directly with the branded version, after which other generic companies will be able to make their own versions.

Vivelle-Dot had sales of $240 million during the 12-month period ended in September, according to IMS Health. The patch is designed to be applied twice a week, and Mylan plans to sell it in the 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg and 0.1 mg strengths.

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