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news.Shire, a specialty biopharmaceutical company, has received a Paragraph IV notice letter from Zydus Pharmaceuticals USA 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.
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Lialda is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. It is also used to prevent the symptoms of ulcerative colitis from recurring.
Shire said that Lialda is protected by the FDA Orange Book listed US Patent no 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the ’720 patent). The patent is expected to expire 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 is expected to be imposed by the FDA on Zydus’ ANDA.