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Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. (“Zydus”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of Shire’ s 1.2g mesalamine delayed release tablets, LIALDA.
LIALDA is protected by the following FDA Orange Book listed patent: U.S. Patent No. 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the “720 patent”). The patent expires in 2020.
Shire is currently reviewing the details of Zydus’ Paragraph IV Notice Letter. 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 Zydus’ ANDA.
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