Zydus tells Shire it has filed US ANDA for ulcerative colitis drug Lialda

Ireland-headquartered Shire says that it has received a Paragraph IV Notice Letter from Zydus Pharmaceuticals USA, part of India's Zydus Cadila, advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1.2g mesalamine delayed release tablets, Lialda, which is approved for the induction of remission in patients with active, mild to moderate ulcerative colitis.

LiaIda, also marketed as Mezavant, generated first-quarter 2010 sales of $63.6 million, up 29% on the like, year-earlier period. It is protected by the FDA Orange Book-listed patent US Patent No 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the "'720 patent"). Shire states that the patent expires in 2020.

The drugmaker is currently reviewing the details of Zydus' 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 US Food and Drug Administration on Zydus' ANDA.