Impax files complaint against Shire, saying Adderall XR patent invalid, not infringed

By E. Janene Geiss

Philadelphia, Nov. 11 - Shire Laboratories Inc. said Friday that Impax Laboratories, Inc. has filed a declaratory judgment complaint against Shire in the U.S. District Court in Delaware.

The complaint involves a dispute over generic versions of Shire's Adderall XR, which is used to treat attention deficit/hyperactivity disorder, Shire officials said in a company news release.

Shire, a subsidiary of Shire Pharmaceuticals Group plc, said the complaint is related to an Abbreviated New Drug Application filed by Impax seeking approval from the U.S. Food and Drug Administration to market and sell generic versions of Shire's 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg Adderall XR products.

On Oct. 20, Shire filed a lawsuit in U.S. District Court for the Southern District of New York against both Barr Laboratories, Inc. and Impax for infringement of the Adderall XR patent, known as '768 patent.

In the latest complaint filed by Impax, Impax alleges that Shire's patent is invalid and not infringed by Impax.

Shire said it received the Adderall XR patent July 5, 2005.

Shire said it also has pending patent litigation in New York and Delaware against Barr and Impax for two other patents.

Basingstoke, England-based Shire Pharmaceuticals Group is a specialty pharmaceutical company focused on product development for central nervous system, gastrointestinal, renal diseases and human genetic therapies.

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