Shire files patent lawsuit after Teva requests FDA approval of generic Intuniv ADHD drug

Shire sues Teva over generic ADHD drug Intuniv

NEW YORK — Irish drugmaker Shire PLC said Friday it filed a patent infringement lawsuit against Teva Pharmaceutical Industries Ltd., which is looking to sell a generic version of Shire’s attention-deficit/hyperactivity drug Intuniv.

Teva said it has requested Food and Drug Administration marketing approval for generic versions of extended-release Intuniv in doses of 1 to 4 milligram. Shire’s lawsuit was filed in the U.S. District Court of the District of Delaware. The Food and Drug Administration will not approve Teva’s generic version for 30 months, or until the patent dispute is resolved, whichever comes first.

The FDA approved Intuniv in September for use by children and adolescents aged 6 to 17 years. Shire said it has marketing exclusivity on the drug until Sept. 2, 2012.

Teva, based in Israel, is the world’s largest generic drugmaker. The company said it does not comment on litigation.

In midday trading, Shire stock rose 87 cents to $66.16. Teva shares added 27 cents to $61.30.