Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed for Schering Corporation's TEMODAR (Temozolomide) 5mg, 20mg, 100mg & 250mg capsules.
The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for TEMODAR.
Barr filed its ANDA containing a paragraph IV certification for a generic TEMODAR product with the U.S. Food & Drug Administration (FDA) in March 2007, and received notification of the application's acceptance for filing in June 2007. Following receipt of the notice from the FDA, Barr notified Schering, the New Drug Application (NDA) holder, and Cancer Research Technology (CRT), the patent owner.
On July 20, 2007, Schering and CRT filed suit in the U.S. District Court of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
TEMODAR(R) (temozolomide) Capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment, and for the treatment of adult patients with refractory anaplastic astrocytoma, ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. The product had sales of approximately $320 million in the U.S., based on IMS sales data for the twelve months ended May 2007.