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Companies settle pending litigation on generic mixed amphetamine salts compound for ADHD

Published in Medical Letter on the CDC and FDA, February 12th, 2006

Shire plc (SHQ) announces that it has settled all pending litigation with Impax Laboratories, Inc. in connection with Impax's abbreviated new drug application and its attempt to market generic versions of Shire's Adderall XR (mixed amphetamine salts) for the treatment of attention deficit hyperactivity disorder (ADHD).

The litigation involves patent infringement lawsuits covering Shire's U.S. patents Nos. 6,322,819, 6,605,300 and 6,913,768. As part of the settlement, Impax has confirmed that its proposed generic products infringe Shire's 6,322,819, 6,605,300 and 6,913,768 patents and that the three patents are valid and enforceable.

Impax will be...

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