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Southern District Court of New York Rules Patent for ACIPHEX® Enforceable


Earlier Decision Confirmed Validity of Composition of Matter Patent

Raritan, N.J.- PriCara™, Unit of Ortho-McNeil, Inc., announced today that the Southern District Court of New York ruled that the patent for ACIPHEX® (rabeprazole sodium 20 mg tablets) is enforceable. PriCara and Eisai Inc. co-promote ACIPHEX® in the United States.

In an earlier ruling, the Court confirmed the validity of the ACIPHEX® composition of matter patent. Today’s decision and the earlier court ruling ensure that the patent is protected and that FDA approved generic versions of rabeprazole sodium will be available no earlier than the date of the patent expiration, May 2013, unless overturned on appeal.

“We are pleased by the Court’s decision, which reflects our belief that the patent for ACIPHEX®, previously found to be valid, is enforceable,” said Jeffrey N. Smith, president, Ortho-McNeil, Inc.

Eisai Co. Ltd. of Tokyo, Japan, holds the patent for ACIPHEX®, and Eisai Inc. of Woodcliff Lake, NJ, is the exclusive licensee.

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. For more information, visit


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