Shares of the Irish drugmaker Shire (SHPGY) were down nearly 11% midday Monday after the FDA decided Saturday to approve a generic version of one of its major drugs, Adderall XR.
The FDA accepted the application of Actavis, a generic-drug maker in the process of a merger with Watson Pharmaceuticals (WPI). Shire’s patent on the popular ADHD drug expired in 2009, but Shire petitioned the FDA to tighten its standards for establishing “bioequivalence” between the generic drug and the original. At the same time that it approved Actavis’ submission, the FDA affirmed its usual testing standards.
Shire said in a press release that it “believes that it will remain competitive in the Adderall XR marketplace through the distribution of branded Adderall XR and through its two authorized generic partners, Teva (TEVA) and Impax (IPXL).”
Nonetheless, Impax’s stock was down 12% midday, though Teva was up 5.8% after it won an unrelated case. Watson shares were up 2.1% midday Monday.
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