Barr confirmed that J&J unit Janssen Pharmaceutica NV, the holder of the Razadyne new drug application, and Synaptech, the holder of the patent, had filed the suit against it. The companies are joined as plaintiffs in the case by other J&J subsidiaries, Janssen LP and Ortho-McNeil Neurologics.
Barr filed an abbreviated new drug application with the FDA for Janssen’s Razadyne ER 8mg, 16mg and 24mg in March 2006. Barr received notification from the FDA of the application’s acceptance for filing in April 2006.
Razadyne ER is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. The drug had annual sales of approximately $54 million for the 12 months ending May 2006, according to data cited by the company.