Barr Confirms Patent Challenge Of Razadyne(R) ER Capsules

http://www.medicalnewstoday.com/medicalnews.php?newsid=46695

08 Jul 2006   

Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that Janssen Pharmaceutica N.V., Janssen, L.P., Ortho-McNeil Neurologics, Inc. and Synaptech, Inc. ("Plaintiff") filed suit against it and its subsidiary, Barr Laboratories, Inc., relating to the patent protecting Razadyne(R) ER (Galantamine Hydrobromide Extended-Release Capsules), 8 mg, 16 mg and 24 mg. The Company indicated it believes it is the first to file an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for the product.

Barr filed an ANDA with the FDA for Janssen's Razadyne ER (Galantamine Hydrobromide Extended-Release Capsules), 8 mg, 16 mg and 24 mg in March 2006. Barr received notification from the FDA of the application's acceptance for filing in April 2006. Following receipt of notice from FDA, Barr notified Janssen Pharmaceutica, N.V., the New Drug Application holder, and Synaptech, the patent owner, of Barr's challenge to the patent protecting Razadyne(R) ER. Plaintiffs filed suit against Barr in the District Court of New Jersey. This suit officially initiates the patent challenge process under the Hatch-Waxman Act.

Razadyne ER is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

Razadyne ER had annual sales of approximately $54 million for the twelve months ending May 2006, according to IMS sales data. Razadyne ER was launched in May 2005.

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.