Impax Laboratories Confirms Patent Challenge Relating To ORACEA

Impax Laboratories has initiated a challenge of the patents listed by Galderma Laboratories, in connection with its ORACEA (doxycycline) delayed-release capsules, 40mg.

Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of ORACEA with the 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, and Galderma Laboratories, filed suit for patent infringement against Impax in the US District Court for the District of Delaware.

Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialise the product. ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.