Impax Laboratories Confirms Patent Challenge Relating To TRILIPIX(R) Delayed-Release Capsules, 135 Mg And 45 Mg

Main Category: Cholesterol
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Mar 2010 - 0:00 PDT

email to a friend   printer friendly   opinions  

Impax Laboratories, Inc. (NASDAQ: IPXL) 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.

Source
IMPAX Laboratories, Inc.

• Additional
• References
• Citations