Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms
that it has initiated a challenge of the patent listed by Abbott
Laboratories and Fournier Laboratories Ireland Ltd. in connection with
its TRILIPIX® (choline fenofibrate) delayed-release capsules,
135 mg and 45 mg.
Impax filed its Abbreviated New Drug Application (“ANDA”) containing a
paragraph IV certification for a generic version of TRILIPIX®
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 owner of its
paragraph IV certification.
On March 12, 2010, Abbott Laboratories and Fournier Laboratories Ireland
Ltd. filed suit for patent infringement against Impax in the United
States District Court for the District of New Jersey. This action
formally initiates the patent challenge process under the Hatch-Waxman
Act. Based on the filing date of the ANDA, the Company believes that it
is the first to file an ANDA with a paragraph IV certification and
expects to be entitled to 180 days of market exclusivity.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s
generic division, will commercialize the products.
TRILIPIX® helps reduce cholesterol and triglycerides (fatty
acids) in the blood. According to Wolters Kluwer Health, U.S. sales of
TRILIPIX® were approximately $276 million across both
strengths for the twelve month period ending January 2010.