Shire sues Teva for patent infringement after Teva files for approval of generic Adderall

By E. Janene Geiss

Philadelphia, March 3 - Shire plc said Friday that its subsidiary, Shire Laboratories Inc., has filed a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania against Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. for infringement of Shire's U.S. Patent Nos. 6,322,819 and 6,605,300.

The lawsuit results from an abbreviated New Drug Application filed by Teva for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg Adderall XR, pursuant to which Teva provided notice that it would seek to market its generic products before the expiration of the '819 and '300 patents in 2018, according to a company news release.

The lawsuit alleges that all of Teva's generic strengths infringe the patents in suit. Pursuant to Hatch-Waxman legislation, there will be a 30-month stay with respect to Teva's proposed 25 mg dosage product, officials said.

Adderall XR is Shire's attention deficit hyperactivity disorder medicine.

Shire is a Basingstoke, England, specialty pharmaceutical company that focuses on developing therapies for the central nervous system, gastrointestinal, human genetic therapies and general products.

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