Ortho-McNeil to appeal patent ruling on Razadyne

Aug 28 2008

Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced that it will appeal yesterday's decision by the U.S. District Court of Delaware, which ruled the patent for Razadyne (galantamine hydrobromide) is invalid.

The decision allows FDA-approved generic versions of immediate-release galantamine hydrobromide to enter the U.S. 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.

"We are disappointed by the court's decision and will appeal this ruling," said Janet Vergis, President of Janssen and Ortho-McNeil Neurologics. "We believe the patent protecting Razadyne is valid and would be infringed by the introduction of a generic galantamine hydrobromide product."

Barr Laboratories and AlphaPharm Pty Ltd. filed Abbreviated New Drug Applications ("ANDAs") to market galantamine hydrobromide before the expiration of the patent, claiming the patent was invalid. Janssen, Janssen Pharmaceutica N.V., and patent owner Synaptech Inc. filed a patent infringement complaint against Barr and AlphaPharm in June 2005. Other lawsuits against generic companies seeking to market galantamine hydrobromide before the expiration of the patent are bound by the outcome of this case.

Razadyne and Razadyne ER are marketed by Ortho-McNeil Neurologics in the United States, and are indicated in the treatment of mild to moderate dementia of the Alzheimer's type.

In clinical trials, the most common side effects are nausea, vomiting, diarrhea, loss of appetite and weight loss. Typically, these side effects are mild and temporary. Razadyne and Razadyne ER may not be for everyone. Some people experience a slowed heart rate, which may lead to fainting. Serious stomach problems can occur in people taking medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) or those at risk for stomach ulcers.

http://www.razadyneer.com/ and http://www.jnj.com/