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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