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www.fdanews.com/articles/88738-shire-sues-over-generic-adderall-xr

SHIRE SUES OVER GENERIC ADDERALL XR

November 14, 2006

UK drugmaker Shire has filed a patent infringement lawsuit against Andrx Pharmaceuticals and Watson Pharmaceuticals to stop the companies' from marketing a generic form of Shire's ADHD treatment drug, Adderall XR.

Shire filed the suits in the U.S. District Court for the District of New Jersey and the Southern District of Florida Nov. 10, claiming all the strengths Andrx seeks to produce violate its patents.

Andrx last month filed an abbreviated new drug application to produce generic versions of 5-, 10-, 15-, 20-, 25- and 30-mg Adderall XR and notified Shire of its plan to market generic versions prior to the patents' expiration dates in 2018.

Shire dropped a similar lawsuit against Barr Laboratories after entering into a settlement agreement in which Barr would purchase the rights to Shire's immediate-release Adderall tablets for $63 million and be allowed to launch generic Adderall XR in April 2009.