Barr Laboratories Ltd. 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 ANDA containing a paragraph IV certification for a generic Eloxatin product with the U.S. 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.
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