Generic player Watson Pharma confirmed (in a press release Here) that company has filed an Abbreviated New Drug Application (ANDA) with Paragraph IV certification against innovator Supernus Pharma and Allergen’s Orange Book listed patents on Trospium chloride Extended Release 60 mg Capsules (Sanctura XR). Watson has challenged following Orange Book listed patent:
US7410978 (Assignee: Supernus; Date of grant: August 12, 2008; Expiry: Feb 1, 2025): The patent covers a pharmaceutical composition suitable for a once-a-day administration of trospium chloride comprising controlled release solid, trospium chloride-bearing particulates, at least a portion of which releases trospium chloride in the lower gastrointestinal (GI) tract, such that once-a-day administration of said pharmaceutical composition provides steady state blood levels of trospium that are comparable to steady state blood levels of trospium achieved with twice daily administration of 20 mg immediate release trospium chloride tablets, said particulates comprising at least one polymer selected from enteric polymers, release controlling polymers, or combinations thereof.
Trospium chloride Extended Release 60 mg Capsules (Sanctura XR) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
Further, innovator Allergan filed patent infringement suit against Watson on July 13, 2009 in the U.S. District Court for the District of Delaware.
Earlier, innovator Allergan got approval to market this product on Aug 3, 2007.
As per press release, Watson believes it may be first to file an ANDA for generic trospium extended-release capsules.
For the twelve-months ended March 31, 2009, Trospium chloride Extended Release 60 mg Capsules (Sanctura XR) had total U.S. sales of approximately $42 million, as per IMS Health data.
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