Abbott Labs files suit against Impax over Simcor patent challenge; Ranbaxy debuts generic Aricept in USA
US generic drugmaker Impax Laboratories (Nasdaq: IPXL) confirmed that it has initiated a challenge of patents listed in connection with the cholesterol lowerer Simcor (niacin/simvastatin) extended-release tablets, 1000/20mg.
Impax filed its Abbreviated New Drug Application containing a paragraph IV certification for a generic version of Simcor (niacin/simvastatin) with the US Food & Drug Administration. Following receipt of the notice from the FDA that the ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner - Abbott Laboratories (NYSE: ABT) - of its paragraph IV certification.
On November 24, Abbott and its subsidiary Abbott Respiratory filed suit for patent infringement against Impax in the United States District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
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