Teva entitled to exclusivity on Provigil, FDA decides

JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

Teva said the FDA granted it 180 days of market exclusivity for a generic version of Cephalon's Provigil (modafinil) after determining that it was the sole first-to-file company; under FDA regulations, the first company to successfully file for approval of a generic version of a drug with a Paragraph IV certification — a legal assertion that the drug's patents are invalid, enforceable or are not infringed — gets 180 days of exclusivity in which to compete directly against the branded version.

Teva launched an authorized generic version of Provigil at the end of March and said it also expects Par Pharmaceutical to launch a generic version of Provigil on Friday under an agreement with the Federal Trade Commission related to Teva's October 2011 acquisition of Cephalon. An authorized generic is the branded version of the drug marketed under its generic name at a reduced price.

In response to the FDA's decision, Mylan filed suit against the agency on Thursday in the U.S. District Court for the District of Columbia seeking to overturn it. Mylan said that Teva could no longer submit an approval application with a Paragraph IV certification due to its acquisition of Cephalon because it could not infringe its own patents. Mylan said that it should be considered the first-to-file company and that Cephalon had previously agreed to its launch of a generic version of Provigil no later than this Friday.

Provigil, which is used to treat conditions like shift work sleep disorder and narcolepsy, had annual sales of about $1.1 billion, according to IMS Health.

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