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Watson subsidiary files application for overactive bladder generic version of Sanctura XR


MORRISTOWN, N.J. A subsidiary of Watson Pharmaceuticals has filed an approval application for a generic version of a drug used to treat overactive bladder.

Watson Labs -Florida announced Wednesday that it had filed an application with the Food and Drug Administration for trospium chloride extended-release capsules in the 60 mg strength. The capsules are a generic version of Allergan’s Sanctura XR.

Because Watson filed its application before the Feb. 1, 2025 expiration of Allergan’s patent, Allergan filed suit against Watson Monday in the U.S. District Court for the District of Delaware, seeking to prevent Watson from marketing the drug. Allergan filed its suit under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s generic Sanctura XR for up to two and a half years or until the two companies resolve the matter before the court.

Sanctura XR had sales of about $42 million for the 12 months ending March 31, according to IMS Health data.

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