Mylan launches generic sleep disorder, bipolar disorder drugs

PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.



The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and used to treat narcolepsy, obstructive sleep apnea and shift work disorder.



There has been some contention surrounding the drug since the Food and Drug Administration determined in April that Teva was the first company to file for regulatory approval of the generic, thus entitling it to 180 days in which to compete with the branded version, as provided for under the Hatch-Waxman Act of 1984. But under an agreement with the Federal Trade Commission related to Teva's acquisition of Cephalon, in October 2011, Par Pharmaceutical Cos. launched the generic version on April 6, while Teva launched an authorized generic, a term used to refer to the branded drug marketed under its generic name at a reduced price. Mylan responded by suing the FDA, asserting that Teva was disqualified from submitting a regulatory filing challenging Provigil's patent protection because a company could not infringe its own patent, and that Mylan should be considered the first-to-file company.



Mylan CEO Heather Bresch said she was "pleased" that Mylan would be launching the drug prior to the expiration of the 180-day exclusivity period. Branded and generic versions of the drug had sales of about $1.3 billion during the 12-month period ended in June, according to IMS Health.



Mylan also announced the launch of lithium carbonate extended-release tablets, a drug used to treat manic episodes of bipolar disorder. Various versions of the drug had sales of about $15.2 million during the 12-month period ended in June, according to IMS.

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