Teva launches generic acamprosate in US

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Teva launches generic acamprosate in US

Generics/News | Posted 08/04/2016 0 Post your comment

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 22 March 2016 that it had launched a generic version of alcohol dependence treatment Campral (acamprosate).

Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Acamprosate is thought to stabilize the chemical balance in the brain that would otherwise be disrupted by alcohol withdrawal.

The originator product Campral is manufactured in the US by Forest Laboratories, while Merck KGaA markets it outside the US. Campral was only approved by the US Food and Drug Administration (FDA) on 29 July 2004, however, it has been legal in Europe since 1989.

Teva has launched its generic as 333 mg acamprosate calcium delayed-release tablets, which is the equivalent of 300 mg of acamprosate. The company points out that treatment with acamprosate calcium delayed-release tablets helps maintain abstinence from alcohol only when used as part of a treatment programme that includes counselling and support.

Acamprosate calcium delayed-release tablets had annual sales of approximately US$14 million in the US, according to IMS data as of December 2015.

Generics makers Barr Laboratories, Glenmark Generics and Mylan also have acamprosate generics approved in the US.

Teva claims to have the largest portfolio of FDA approved generics on the market and states that it has over 375 generics available in the US.

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Source: US FDA, Teva