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Sanofi launches authorized leflunomide generic in US Posted 16/10/2015

Sanofi US announced on 1 October 2015 that the company’s US generics division, Winthrop, had launched an authorized generic version of Arava (leflunomide) tablets.

Arava is an immunosuppressive disease-modifying anti-rheumatic drug (DMARD), used in active moderate-to-severe rheumatoid arthritis and psoriatic arthritis.

More than 1.5 million Americans live with rheumatoid arthritis, which can cause irreversible joint damage. DMARDs, such as Arava, help to reduce signs and symptoms, inhibit structural damage as evidenced by X-ray erosions and joint space narrowing and improve physical function.

Arava (leflunomide) was approved in the US in 1998, in the EU in 1999 and in Japan in 2003. Arava’s patents and exclusivity expired in the EU in 2009 and in the US in 2007.

The authorized generic version of Arava has the identical chemical makeup as the original Arava first approved by the US Food and Drug Administration in 1998.

Opinion on authorized generics is split, with some believing that they are pro-competitive – offering drugs to consumers at lower prices than the brand-name product. Others, however, believe that authorized generics harm competition by drawing revenues away from generics firms during the 180-day exclusivity period provided for the first-to-file. In 2013, the US Federal Trade Commission (FTC) released a report which suggests that authorized generics can reduce both retail and wholesale drug prices [1].

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1.   GaBI Online - Generics and Biosimilars Initiative. Authorized generics reduce drug prices [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16]. Available from: www.gabionline.net/Reports/Authorized-generics-reduce-drug-prices

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Source: Sanofi

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