Jul 21 2008
PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today that the U.S. Federal Circuit Court of Appeals affirmed the judgments of the United States District Court for the Southern District of New York that the patent for Aciphex (rabeprazole sodium 20 mg tablets) is valid and enforceable.
Today's decision ensures that the patent for Aciphex remains in force and also directs the U.S. Food and Drug Administration 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.
Eisai Co., Ltd. of Tokyo, Japan, holds the patent for Aciphex. PriCara and Eisai Inc. co-promote Aciphex in the United States.
"We are pleased by the court's decision, which reflects our belief that the patent for Aciphex is both valid and enforceable," said Jim Mitchell, General Manager, PriCara.
Aciphex is used for the treatment of persistent heartburn and other symptoms associated with acid reflux disease. It also is used for the short- term treatment in the healing and symptom relief of erosive acid reflux disease -- gastroesophageal reflux disease -- and to maintain healing of erosion and relief of heartburn symptoms that happen with acid reflux disease.
Aciphex has a well-established safety profile. The most common side effect possibly related to Aciphex is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin) may need to be monitored closely by their doctor.