Shire receives Paragraph IV Notice Letter over generic INTUNIV ANDAs from Teva Pharmaceuticals

Shire plc (LSE: SHP, NASDAQ; SHPGY), announces that it has received a Paragraph IV Notice Letter from Teva Pharmaceuticals USA, Inc. ("Teva") advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1 mg, 2mg, 3 mg, and 4mg guanfacine hydrochloride extended release tablets, INTUNIV(TM).

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 ("the '599 patent") and U.S. Patent No. 6,811,794 ("the '794 patent") 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.

The 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.

SOURCE Shire Pharmaceutical