BARR CHALLENGES J&J'S PATENT FOR RAZADYNE ER

Barr Laboratories has filed an application with the FDA to market a generic version of Johnson & Johnson's (J&J) Alzheimer's drug Razadyne ER.

Barr said it believes it is the first to file an abbreviated new drug application with the FDA for Razadyne (galantamine hydrobromide) extended-release capsules in 8-, 16- and 24-mg doses. The drug treats mild-to-moderate dementia associated with Alzheimer's disease.

In response, J&J subsidiary Janssen Pharmaceutica, Ortho-McNeil Neurologics and Synaptech have filed a patent infringement lawsuit against Barr in the U.S. District Court of New Jersey, Barr said. Janssen is the new drug application holder, Synaptech is the patent owner and Ortho-McNeil markets the drug.

J&J spokeswoman Ambre Morley said the drugmaker believes the Razadyne ER patent is valid and the company intends to "vigorously" defend it.

Razadyne ER had annual sales of approximately $54 million for the 12-month period ending May 2006, according to IMS sales data.

Last year, Janssen and Synaptech filed a lawsuit against Barr in the U.S. District Court of Delaware after Barr applied to market Razadyne tablets in 4-, 8- and 12-mg dosage strengths. That case is scheduled to go to trial in October 2007, according to court documents.