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 against US5338874 {(Expiry: 10-7-2013) which covers Optically pure cis-oxalato (trans- 1-1,2-cyclohexanediamine) Pt(II) as product} for a generic Eloxatin product with the USFDA, and following FDA notification of the application's acceptance for filing, the Company notified the New Drug Application (NDA) and patent owner. There are 6 orange book listed patent and innovator sued Barr over US5338874.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 on 4th january 2008 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.
Thursday, 10 January 2008
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