PITTSBURGH (AP) -- Mylan Inc. said Friday it will start selling a generic version of the sleep disorder drug Provigil under the terms of a new settlement with Teva Pharmaceutical Industries Ltd., the company that makes Provigil.
Mylan said it will start selling a lower-cost generic version of Provigil on August 10, before Teva's marketing exclusivity expires. It will sell two strengths of the drug, and the brand-name versions had U.S. sales of $1.2 billion in the year that ended March 31. The agreement between the companies is being reviewed by the Food and Drug Administration.
Provigil is approved to treat tiredness caused by narcolepsy, obstructive sleep apnea, and changes in work schedule. Provigil was originally sold by Cephalon Inc. Teva bought Cephalon in October, and as part of that deal, antitrust regulators required Teva sell the U.S. rights to generic Provigil to another company. Par Pharmaceutical Cos. bought those rights and began selling a generic version of the drug in April.
The Food and Drug Administration ruled that Teva was the first company to file an application on two of the patents protecting Provigil. Mylan sued to gain marketing approval and exclusivity.
Citi Investment Research analyst John Boris said Teva started selling its own generic March 30, and since generic competition has been limited so far, Teva's sales of Provigil might be stronger than expected.
Shares of Mylan rose 15 cents to $21.54 by midday, while Teva shares rose 22 cents to $39.24.
- Food and Drug Administration