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Teva Gets FDA Approval for Generic ADHD Drug

From Associated Press (February 14, 2013)

NEW YORK -- Teva Pharmaceutical Industries Ltd. said Thursday that it received marketing approval for a generic version of Shire PLC’s Adderall XR, a treatment for attention deficit hyperactivity disorder.

The Food and Drug Administration approved Teva’s generic in six strengths from 5 milligrams to 30 milligrams. Teva sells an authorized version of the drug supplied by Shire and is not launching sales of its own generic right now. The product supply agreement between the companies ends April 1, 2014.

Teva said U.S. sales of the brand-name version and generic versions of Adderall XR totaled $2 billion in 2012.

Teva has been selling an authorized generic version of the drug since April 2009 as part of an agreement with Shire. The agreement resolved a patent infringement lawsuit between the companies. Impax Laboratories Inc. began selling an authorized generic version of the drug in October 2009. Actavis Inc. launched its own version in June, further cutting the price.

Shire, which reported its fourth-quarter results Thursday, said it gets "insignificant" income from its deal with Teva.

Adderall XR, an extended-release version of an older ADHD drug called Adderall, was once Shire’s biggest selling product, bringing the company $1.1 billion in revenue in 2008. Sales have fallen because of the introduction of the lower-priced generic versions. Shire’s current top product is Vyvanse, a newer ADHD drug that still has patent protection.

Shares of Teva rose 11 cents to $38.84 in midday trading while Shire’s U.S. shares dropped $6.43, or 6.4 percent, to $93.94. Shire said sales of Adderall fell 19 percent to $429 million in 2012, and Vyvanse sales rose 28 percent to $1.03 billion.

Impax shares fell 7 cents to $19.92 by midday.


Posted: February 2013