Par launches generic version of Provigil

Branded version has annual sales of $1.1 billion

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

The launch occurred under an agreement between the Federal Trade Commission and Teva Pharmaceutical Industries, which acquired Cephalon, the maker of Provigil, in October 2011. On Thursday, Teva — which launched an authorized generic version of Provigil on March 29 — said the Food and Drug Administration has found it was the sole first filer of a regulatory approval application for generic Provigil.

Mylan sued the FDA in a federal court in response to the decision, saying that Teva had forfeited its right to submit an approval application for generic Provigil that challenged what was now its own patent, and that Mylan should be recognized as the first-to-file company instead.

Provigil has annual sales of about $1.1 billion, according to IMS Health.


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