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’.

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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

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