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Impax Laboratories Confirms Patent Challenge Relating To ORACEA(R) Delayed-Release Capsules, 40mg

September 22, 2009

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by the agency of Galderma Laboratories, L.P. in relation through its ORACEA® (doxycycline) delayed-release capsules, 40 mg.

Impax filed its Abbreviated New Drug Application (”ANDA”) containing a paragraph IV certification for a generic version of ORACEA® with the U.S. Food & Drug Administration (”FDA”). Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application possessor and patent owners of its paragraph IV certification.

On September 18, 2009, The Research Foundation of State University of New York; New York University; Galderma Laboratories Inc.; and Galderma Laboratories, L.P. filed suit for clear 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.

Once the ANDA is approved by dint of. FDA, Global Pharmaceuticals, Impax’session generic division, will commercialize the crops.

ORACEA® is indicated for the treatment of sole inflammatory lesions (papules and pustules) of rosacea in of age patients. According to Wolters Kluwer Health, U.S. sales of ORACEA® were approximately $104 million for the twelve-month period ending July 2009.

Source
Impax Laboratories, Inc.

Written by Samanta · Filed Under Pharmacy Industry News