Impax says Shire affiliate files complaint for third Adderall XR patent

By E. Janene Geiss

Philadelphia, Oct. 24 - Impax Laboratories, Inc. announced Monday that an affiliate of Britain's Shire Pharmaceuticals Group plc has filed a complaint against the company alleging patent infringement on a third patent of Adderall XR.

Impax officials said it has not yet received the complaint, filed in the U.S. District Court for the Southern District of New York, according to a company news release.

Impax has submitted its ANDA filing with the U.S. Food and Drug Administration, stating it believes the generic versions of Adderall XR tablets do not infringe on the two patents listed in the FDA's Orange Book or that those two listed patents are invalid or unenforceable.

The company is currently in litigation with Shire in the U.S. District Court for the District of Delaware regarding Shire's claim that the company's ANDA infringes the two Orange Book listed patents. A trial is scheduled for February 2006, officials said.

The latest patent at issue was not listed in the FDA Orange Book and therefore not included in the company's previous certification. The company said it believes that its generic versions of Adderall XR tablets do not infringe this third patent or that this patent also is invalid or unenforceable.

Adderall XR is marketed by Shire for attention deficit/hyperactivity disorder. U.S. sales of Adderall XR tablets were about $770 million for the company's 2005 fiscal year.

Impax is a Hayward, Calif.-based pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.