Published on September 21, 2009 at 7:49 AM
Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Galderma Laboratories, L.P. in connection with 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 holder 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 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.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the product.
ORACEA® is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. According to Wolters Kluwer Health, U.S. sales of ORACEA® were approximately $104 million for the twelve-month period ending July 2009.
http://www.impaxlabs.com/