Depomed Files Patent Infringement Lawsuit Against Gralise(R) ANDA Filers
05-Mar-2012
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MENLO PARK, Calif. - Depomed Inc. today announced in a press release that it has filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against three companies that have filed Abbreviated New Drug Applications with the FDA to market generic Gralise® (gabapentin), Depomed's once-daily gabapentin product for the management of postherpetic neuralgia.
The lawsuit claims infringement of Depomed's six US patents listed for Gralise in the FDA's Orange Book, the last of which expires in 2024, by each defendant's proposed generic product. Depomed has received a Paragraph IV certification notice from each defendant alleging that Depomed's patents will not be infringed by the proposed generic product, or the patents are invalid or unenforceable. The defendants in the lawsuit are: Actavis Elizabeth LLC and an affiliated company; Watson Laboratories Inc. – Florida and affiliated companies; and Incepta Pharmaceuticals Co. Ltd.
Depomed has commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving the Gralise ANDAs for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.
Depomed Inc. is a specialty pharmaceutical company with two approved and marketed products. GraliseTM (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN).