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news.Ortho-McNeil Neurologics, division of Ortho-McNeil-Janssen Pharmaceuticals, has announced that it will appeal decision by the US District Court of Delaware, which ruled the patent for Razadyne is invalid.
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The decision allows FDA-approved generic versions of immediate-release galantamine hydrobromide to enter the US marketplace ‘at risk’ pending an appeal. A favorable ruling would have provided patent protection for Razadyne IR until the patent expires on December 14, 2008.
Razadyne and Razadyne ER are marketed by Ortho-McNeil Neurologics in the US, and are indicated in the treatment of mild to moderate dementia of the Alzheimer’s type.
Janet Vergis, president of Janssen and Ortho-McNeil Neurologics, said: “We are disappointed by the court’s decision and will appeal this ruling. We believe the patent protecting Razadyne is valid and would be infringed by the introduction of a generic galantamine hydrobromide product.”