Teva Pharmaceuticals USA has filed an Abbreviated New Drug Application (ANDA) for a generic version of Shire's attention deficit hyperactivity disorder (ADHD) drug Intuniv.
Shire received a Paragraph IV Notice Letter from Teva and now has 45 days to decide if it will file a patent infringement suit.
The exclusivity period for Intuniv runs until September 2012, so applications for generic versions cannot be approved until then.
If Shire brings a suit pursuant to the Hatch Waxman regulations, a stay of approval of up to 30 months will be imposed by the US Food & Drug Administration on Teva's ANDA.
Company news from ShareCast
Teva tells Shire of generic ADHD drug
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