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news.PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, has announced that the US Federal Circuit Court of Appeals has affirmed the judgments of the US District Court of New York that the patent for Aciphex is valid and enforceable.
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The decision ensures that the patent for Aciphex (rabeprazole sodium 20mg tablets) remains in force and also directs the FDA to change the effective date of Teva Pharmaceutical’s approval to market its generic version of rabeprazole sodium to no earlier than May 2013, the date of the Aciphex patent expiration.
The court’s decision also affects Dr Reddy’s Pharmaceutical Company’s application for approval for its generic version of the drug, which now will not receive final approval before May 2013.
Aciphex is used for the treatment of persistent heartburn and other symptoms associated with acid reflux disease. It is also used for the short-term treatment in the healing and symptom relief of erosive acid reflux disease – a gastroesophageal reflux disease – and to maintain healing of erosion and relief of heartburn symptoms that happen with acid reflux disease.
Eisai Co of Tokyo, Japan, holds the patent for Aciphex. PriCara and Eisai co-promote Aciphex in the US.