Barr’s application to market an abbreviated form of the drug has already been accepted for filling by the FDA, triggering the response by J&J.
The suit has been filed in the District Court of Delaware by Janssen Pharmaceutica Products and Synaptech, subsidiary companies of J&J. The case relates to the patents protecting Razadyne (galantamine hydrobromide), 4mg, 8mg and 12mg tablets.
Barr applied to the FDA to market a generic version of Razadyne in February 2005, acceptance of the filing was issued in April 2005. Following receipt of this notice, Barr informed Janssen and Synaptech of the company’s intention to challenge the patent.
Janssen holds the new drug application for the product and Synaptech owns the patent which expired in February 2005.
A further six other pharmaceutical companies have sought applications to market generic versions of Razadyne. Janssen has indicated they are in the process of evaluating these challenges to the patent.
Razadyne, formerly Reminyl, is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Annual sales of the drug are worth approximately $247 million a year according to Barr.