Teva loses fight against generic glatiramer acetate

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Teva loses fight against generic glatiramer acetate

Genéricos/Novedades | Posted 02/08/2013 0 Post your comment

On 26 July 2013 the US Federal Circuit Court of Appeals invalidated several of Teva’s patents on Copaxone (glatiramer acetate), including one that protected the drug until September 2015.

The court specifically ruled that the asserted claims of four patents expiring in May 2014 and one patent expiring in September 2015 were invalid for being indefinite. The decision means that Teva’s blockbuster multiple sclerosis drug could be open to generics competition from 25 May 2014.

The ruling by the Court of Appeals reverses a previous district court’s finding, which found Teva’s patents for Copaxone, which cover chemical composition, methods of using the product and processes for manufacturing the product, to be valid.

Teva sued Sandoz in 2008 and Mylan in 2009 after they submitted abbreviated new drug applications to FDA for approval of generic versions of the glatiramer acetate drug and Teva’s Citizen’s Petitions to block approval of the generics were refused by FDA [1].

Teva unsurprisingly stated that it was disappointed with the decision. The company has not given up yet though, it is trying to make FDA approval as difficult as possible for any generics makers, by arguing that given the complexity of Copaxone the only way ‘to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS [relapsing-remitting multiple sclerosis] patients’. They add that ‘differences between a proposed generic product and Copaxone could lead to immunogenic effects in patients’.

The drug is a major earner for the Israeli-based firm, generating about 20% of Teva’s annual revenue of about US$20 billion. Worldwide sales of Copaxone in 2013 were US$4 billion.

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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 2013 Aug 2]. 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 2013 Aug 2]. Available from: www.gabionline.net/Generics/News/Teva-again-files-citizen-petition-against-generic-Copaxone

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Source: Mylan, Sandoz, Teva, US Federal Court of Appeals