First generics of Cymbalta approved by FDA

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

First generics of Cymbalta approved by FDA

Generics/News | Posted 10/01/2014 0 Post your comment

The US Food and Drug Administration (FDA) announced on 11 December 2013 that it had approved the first generic versions of duloxetine delayed-release capsules, a prescription medicine used to treat depression and other conditions.

Aurobindo Pharma, Dr Reddy’s Laboratories, Lupin, Sun Pharma Global, Teva Pharmaceuticals USA and Torrent Pharmaceuticals have all received FDA approval to market duloxetine in various strengths.

The products are generic versions of Eli Lilly’s anxiety and depression drug Cymbalta, which had 2012 sales of US$4.9 billion. The US patent on Cymbalta expired on 11 December 2013 [1]. In Europe and Australia, the patent on Cymbalta already expired in December 2012. However, data exclusivity in Europe lasts until August 2014 and in Canada data and market exclusivity periods last until May 2016.

FDA press release highlights the fact that the drug has a boxed warning concerning an increased risk of suicidal thinking and behaviour during initial treatment in children, adolescents, and young adults ages 18 to 24. The agency does point out, however, that ‘depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary’.

Related articles

Generic olanzapine now approved in US

Sun Pharma continues to expand its generics portfolio

Reference

1. GaBI Online - Generics and Biosimilars Initiative. The biggest drug patent losses for 2013 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Generics/General/The-biggest-drug-patent-losses-for-2013

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.

Source: FDA