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Actavis seeks approval for Alzheimer's patch

Novartis sues generic drug maker

PARSIPPANY, N.J. — Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

The generic drug maker said it had filed with the Food and Drug Administration an amendment to its regulatory application for rivastigmine transdermal system to include the 13.3 mg-per-24-hours dosage strength, a generic version of Novartis' Exelon. Novartis filed suit against Actavis on Thursday in the U.S. District Court for the District of Delaware seeking to prevent commercialization of the generic version.

In November 2011, the company, then known as Watson Pharmaceuticals, filed an application with the FDA for a generic version of Exelon in the 4.6 mg-per-24-hours and 9.5 mg-per-24-hours strengths. Novartis sued to prevent commercialization of those strengths separately.

Actavis said it was likely the first company to file applications for generic versions of Exelon, which would entitle it to 180 days of market exclusivity in which to compete directly against the branded version. Exelon had sales of about $521 million during the 12-month period that ended in January, according to IMS Health.

 

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