Barr Pharmaceuticals confirms Eloxatin injectable patent challenge

Jan 10 2008

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, has initiated a challenge of the patents listed by Sanofi-Aventis U.S. LLC in connection with its Eloxatin(R) (Oxaliplatin Aqueous Solution), 5mg/mL Injectable.

Barr filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Eloxatin product with the U.S. Food & Drug Administration (FDA), and following FDA notification of the application's acceptance for filing, the Company notified the New Drug Application (NDA) and patent owner.

On January 4, 2008, Sanofi-Aventis U.S. LLC, Sanofi-Aventis and Debiopharm S.A. filed suit in the U.S. District Court of New Jersey to prevent the Company from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Eloxatin (Oxaliplatin Aqueous Solution), 5mg/mL Injectable, used in combination with infusional 5-FU/LV, is indicated for adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor, and is indicated for the treatment of advanced carcinoma of the colon or rectum. The product had sales of approximately $1.1 billion in the U.S., based on IMS sales data for the 12-months ended October 2007.