Sandoz launches authorized fluvastatin generic in US

Generics/News | Posted 06/11/2015 post-comment0 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.

statin drug V15e08

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].

Related article
Pay-for-delay on the increase in the US

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.

Source: Sandoz, US FDA

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010