Thursday, March 22, 2007

Para IV Move: EFFEXOR XR™ (Wyeth/Lupin)

Wyeth has filed a patent infringement complaint against Lupin Pharmaceuticals in the US District Court for the District of Maryland after receiving a letter dated January 26, 2007 from Lupin that it had filed an abbreviated new drug application (ANDA) No. 78-543 to obtain US FDA approval for the commercial manufacture, use, and sale of Venlafaxine hydrochloride extended-release capsules in 37.5mg, 75mg, and 150mg dosage strengths, generic versions of Wyeth’s Effexor XR capsules before expiry of the US Patent Nos. 6,274,171 (the ‘171 patent), 6,403,120 (the ‘120 patent) and 6,419,958 (the ‘958 patent). Lupin has made Para IV certification with respect to ‘171 and ‘120 patents alleging that the claims of ‘171, ‘120 and ‘958 patents are not infringed and/or invalid. In its complaint, Wyeth has moved action for intentionally and willfully infringement.

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