Wednesday 8 October, 2008

Canadesartan+Hydrochlorthiazide: Paragraph IV filed


A generic company has filed Paragraph IV against Atacand HCT® (Candesartan and Hydrochlorothiazide) Tablets 16 mg/12.5mg and 32mg/12.5mg on June 25, 2008. The said combination was approved by USFDA on Sep 5, 2000 . Also, innovator got approval on another combination 32mg ;25 mg on May 16, 2008.

Following Orange Book patents are listed for this product:

US5705517 (Expiry: Apr 18, 2011): Covers candesartan as product
US5196444 (Expiry: Jun 4, 2012): Which covers A stable crystal of 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)-biphenyl-4-yl]methyl]benzimidazole-7-ca rboxylate.
US5534534 (Expiry: Jul 9, 2013): A pharmaceutical composition of Candesartan
US5721263 (Expiry: Feb 24, 2015): Covers a pharmaceutical composition, which comprises (.+-.)-1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7 -carboxylate or a pharmaceutically acceptable salt thereof in combination with hydrochlorothiazide (or diuretic)
US5958961 (Expiry: Jun 6, 2014): Covers pharmaceutical combination
Earlier, the monotherapy of Atacand received a Para IV filing back in 2006 from generic player Sandoz. The generic player filed its Para IV against polymorph and formulation patents and Paragraph III against product patent. Importantly, innovator did not sued the generic player.

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