Sandoz launches authorized fluvastatin generic in US

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Sandoz launches authorized fluvastatin generic in US

Generics/News | Posted 06/11/2015 0 Post your comment

Sandoz, the generics division of Novartis, announced on 16 October 2015 the launch of an authorized generic version of Lescol (fluvastatin) tablets.

The originator product, Lescol, is made by Novartis. It belongs to a group of drugs called 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase inhibitors or statins. Lescol reduces levels of ‘bad’ cholesterol [low-density lipoprotein (LDL)] and triglycerides in the blood, while increasing levels of ‘good’ cholesterol [high-density lipoprotein (HDL)]. Approximately 71 million American adults (33.5%) have high LDL, or ‘bad’ cholesterol.

Lescol was approved in the US in 1993 and US Patent Number 6,242,003, which covers oral dosage and release methods for the fluvastatin-based drug, is only set to expire in October 2020.

Some have criticized authorized generics saying that they harm competition by drawing revenues away from generics firms during the 180-day exclusivity period provided for the first-to-file. However, others believe that they are pro-competitive – offering drugs to consumers at lower prices than the brand-name product. In 2013, the US Federal Trade Commission released a report, which suggests that authorized generics can reduce both retail and wholesale drug prices [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Authorized generics reduce drug prices [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Reports/Authorized-generics-reduce-drug-prices

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Source: Sandoz, US FDA