Shire PLC (SHP.LN) said Tuesday it has received a Paragraph IV Notice Letter from Teva Pharmaceuticals U.S.A, Inc. advising of the filing of an Abbreviated New Drug Application, or ANDA, for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV.
MAIN FACTS:
-INTUNIV is protected by three FDA Orange Book listed patents: U.S. Patent No. 5,854,290, Use of Guanfacine in the Treatment of Behavioral Disorders; U.S. Patent No. 6,287,599 and U.S. Patent No. 6,811,794 both titled Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles.
-The three patents expire in 2015, 2020 and 2022, respectfully.
-Shire is currently reviewing the details of Teva's Paragraph IV Notice Letter which was only directed to the `599 and `794 patents.
-Hatch-Waxman exclusivity period for INTUNIV runs until September 2, 2012 therefore, ANDAs for generic versions of INTUNIV cannot be approved prior to the end of that exclusivity period.
-Under the Hatch-Waxman Act, Shire has 45 days from the receipt of the Notice Letter to determine if it will file a patent infringement suit.
-If Shire brings suit pursuant to the Hatch Waxman regulations, a stay of approval of up to 30-months will be imposed by the FDA on Teva's ANDA.
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