Teva continues its fight to prevent generic glatiramer acetate

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Teva continues its fight to prevent generic glatiramer acetate

Generics/News | Posted 02/09/2011 0 Post your comment

Teva Pharmaceutical Industries (Teva) has not given up the fight to keep generics competition away from its blockbuster drug, Copaxone (glatiramer acetate). The company announced on 29 August 2011 that a US federal court had rejected interpretation claims from its challengers in patent infringement lawsuits over its proprietary multiple sclerosis treatment, setting a trial date of 7 September 2011.

The US District Court for the Southern District of New York ruled in favour of Teva regarding interpretation of the patent claims involved in two patent infringement lawsuits against Sandoz and Momenta Pharmaceuticals, and Mylan and Natco with respect to Teva’s Copaxone.

Sandoz and Momenta have formed a partnership on a generic version, and Mylan has a deal with Natco for global marketing of their generic version.

Teva sued Sandoz in 2008 and Mylan in 2009 after they submitted abbreviated new drug applications to FDA for approval of generic version of the glatiramer acetate drug. Citizen’s Petitions submitted by Teva requesting FDA to block the approval of generic version of its glatiramer acetate drug, however, were refused by FDA in November 2009 and in May 2010 [1].

The US patents on Copaxone are valid until 2014 and the drug is a major earner for the Israel-based firm. Third-quarter sales in 2010 were US$808 million, up 4% on the same period in 2009 [2].

Teva, which built its successful generics business based on challenging patents for proprietary drugs, now finds itself on the other side of the fence having to defend its own proprietary product.

Teva announced that it was ‘pleased with the court’s decision and awaits the start of a trial on 7 September 2011’.

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References

1. GaBI Online - Generics and Biosimilars Initiative. FDA rejects second citizen petition for Teva’s glatiramer acetate drug [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 02]. Available from: www.gabionline.net/Pharma-News/FDA-rejects-second-citizen-petition-for-Teva-s-glatiramer-acetate-drug

2. GaBI Online - Generics and Biosimilars Initiative. Teva again files citizen petition against generic Copaxone [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 02]. Available from: www.gabionline.net/Generics/News/Teva-again-files-citizen-petition-against-generic-Copaxone

Source: Teva