Thursday 10 January, 2008

Barr to fight against Oxaliplatin product patent

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.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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