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Published on 6 April 2010

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Shire receives second INTUNIV paragraph IV notice letter

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Shire plc announces that it has received a second Paragraph IV Notice Letter this time from Actavis Elizabeth LLC (Actavis) advising of the filing of an Abbreviated New Drug Application (ANDA)

The filing is for a generic version of Shire’s 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV.

Shire had previously reported in March 2010 of the receipt of a Paragraph IV Letter from Teva Pharmaceuticals USA, Inc. regarding Teva’s ANDA for a generic version of Shire’s 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets.

INTUNIV is protected by three FDA Orange Book listed patents: U.S. Patent No. 5,854,290 (“the ‘290 patent”) titled 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 Actavis Paragraph IV Notice Letter which was directed to the ‘290, ‘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 Actavis ANDA.



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