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Shire Gets New Challenge on ADHD Drug Adderall XR

From Associated Press (February 24, 2011)

NEW YORK -- Irish drug maker Shire PLC said Thursday that Watson Pharmaceuticals Inc. is seeking marketing approval for a new generic version of Shire's attention deficit hyperactivity disorder treatment Adderall XR.

Shire said Adderall XR has patent protection in the U.S. until April 2019. The company has 45 days to decide if it will file a patent infringement lawsuit against Watson. If Shire does file a lawsuit, regulators will not approve Watson's generic for up to 30 months, or until a court makes a ruling on the patents and the lawsuit.

The companies settled a previous patent dispute involving Adderall XR in November 2007. Shire said the details of that settlement are confidential, and Watson's new filing relates to a product that is not covered under the 2007 settlement.

Several drug makers will be able to sell generic versions of Adderall XR before its patents expire, but Watson is not one of them. Shire settled disputes with Impax Laboratories Inc., Teva Pharmaceutical Industries Ltd., and Novartis AG's Sandoz unit by agreeing to let those companies sell their generics before the patents supporting Adderall XR expire. In return, Shire will get royalties on sales of the generics. The companies agreed to drop challenges to the patents supporting the drug.

Watson also acknowledged that the patents supporting Adderall XR are valid, Shire said.

Shire shares rose 47 cents to close at $81.45. Watson shares gained 19 cents to close at $55.13.

Posted: February 2011