Watson confirms generic Atelvia patent challenge

PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to market a generic version of a postmenopausal osteoporosis treatment.

The generic drug maker said its subsidiary, Watson Lavs, has filed an abbreviated new drug application with the Food and Drug Administration for risedronate sodium delayed-release tablets in the 35-mg. strength. The drug is a generic version of Atelvia, which is manufactured and distributed by Warner Chilcott.

In response to the ANDA filing, Warner Chilcott filed suit against Watson last week in the U.S. District Court for the District of New Jersey to block Watson from commercializing generic Atelvia prior to the expiration of patent Nos. 7,645,459 and 7,645,460. The suit was filed under the Hatch-Waxman Act, Under the Hatch-Waxman Act, which puts a stay of FDA approval on Watson's drug for 30 months, or until the companies settle the matter.

Watson, however, said it believes it may be a "first applicant" to file an ANDA for the generic version of Atelvia and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

Atelvia had total U.S. sales of about $17 million for the 12 months ended in August, according to IMS Health data.


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