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news.Seeking approval to market trospium chloride 60mg capsules prior to the expiration of the patent
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Watson Laboratories (Watson), a subsidiary of Watson, has filed an Abbreviated New Drug Application (ANDA) with the FDA. The company is seeking approval to market its trospium chloride extended-release 60mg capsules, prior to the expiration of a patent owned by Supernus Pharmaceuticals.
Trospium chloride extended-release capsules are the generic version of Allergan’s Sanctura XR product. It is used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
Earlier, Allergan filed suit against Watson on July 13, 2009 in the US District Court for the District of Delaware, seeking to prevent Watson from commercializing its products prior to expiration of US patent number 7410978. Allergan’s suit resulted in a stay of final FDA approval of Watson’s ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner.
Watson believes it may be the first to file an ANDA for generic trospium extended-release capsules.