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news.Shire Development and Shire Pharmaceutical Development, subsidiaries of Shire plc, have filed a lawsuit against Cadila Healthcare, doing business as Zydus Cadila and Zydus Pharmaceuticals (USA), in the US District Court for the District of Delaware, for the infringement of US Patent No. 6,773,720 (the ’720 patent).
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The lawsuit was filed as a result of an abbreviated new drug application (ANDA) filed by Zydus seeking FDA approval to market and sell generic versions of Lialda (mesalamine) prior to the expiration of the ‘720 patent.
Lialda is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Lialda is also used to prevent the symptoms of ulcerative colitis from recurring.
Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving the Paragraph IV notification letter from Zydus, the FDA must refrain from approving Zydus’ ANDA for 30 months, or until a district court decision finding that the patent is invalid or not infringed, whichever occurs earlier.
The stay on generic approval will expire in November 2012, unless terminated earlier.