DUBLIN Teva is hoping to get a generic drug for treating attention deficit hyperactivity disorder into the market a little early.
British drug maker Shire announced Tuesday that it received notice of Teva’s filing of a regulatory approval application with the Food and Drug Administration for a generic version of Intuniv (guanfacine hydrochloride) extended-release tablets in the 1-mg, 2-mg, 3-mg and 4-mg strengths. Teva’s application contained a Paragraph IV certification, a legal assertion that Shire’s patents covering Intuniv are invalid, unenforceable or won’t be infringed by Teva’s version of the drug.
Currently, Intuniv is covered by three patents, which expire in 2015, 2020 and 2022. Teva’s Paragraph IV certification was directed at the last two, and Shire said it was reviewing the notice letter.
The market-exclusivity period for Intuniv lasts until September 2012, meaning that the FDA can’t approve Teva’s version until then. Under the Hatch-Waxman Act, Shire has a month and a half to decide whether to sue Teva for patent infringement. If it does that, the FDA will be prohibited from approving Teva’s drug for two and a half years, or until the two companies reach a settlement or one wins the case.