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news.Barr Laboratories, a subsidiary of Barr Pharmaceuticals, has initiated a challenge of the patents listed by Sanofi-Aventis US in connection with its Eloxatin 5mg/mL injectable indicated for the treatment of advanced carcinoma of the colon or rectum.
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Barr filed an abbreviated new drug application containing a paragraph IV certification for a generic Eloxatin product with the FDA, and following FDA notification of the application’s acceptance for filing, the company notified the new drug application and patent owner.
On January 4, 2008, Sanofi-Aventis US, Sanofi-Aventis and Debiopharm filed suit in the US 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.