FDA ordered to let Watson sell generic Actos

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FDA ordered to let Watson sell generic Actos

Generics/News | Posted 09/11/2012 0 Post your comment

Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered FDA to approve Watson’s generic pioglitazone against the agency’s decision to bar Watson during the first six months of generics availability.

In December 2010, after a long legal battle, Watson, along with generics rivals Mylan and Ranbaxy Laboratories (Ranbaxy), had managed to gain licence agreements with Takeda Pharmaceuticals for the marketing of pioglitazone in the US assuming market entry on 17 August 2012 [1]. However, despite Mylan and Ranbaxy’s abbreviated new drug applications being approved by FDA on 17 August 2012, thus granting them 180-days exclusivity, the agency refused to do the same for Watson.

FDA’s decision prompted the generics maker to sue the agency in August 2012 claiming that FDA’s decision to bar it from participating in the exclusivity period was ‘arbitrary, capricious and contrary to law’. US District Judge Amy Berman Jackson agreed and ordered FDA to immediately allow Watson to participate in what remains of the 180-day exclusivity period previously awarded to competitors Mylan and Ranbaxy.

Watson announced on 26 October 2012 that it had finally received approval from FDA for its generic pioglitazone tablets in 15 mg, 30 mg and 45 mg dosages. Watson also announced on 31 October 2012 that it would adopt a new global name – Actavis – effective in 2013.

Despite the reversal of the FDA decision, Watson is still the loser here. The company has missed out on two and a half months of joint exclusivity, which may have cost the company millions of dollars. According to IMS Health data, for the 12 months ended 31 August 2012, Actos and its generics equivalents had total US sales of approximately US$2.7 billion.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. FDA approval for generic diabetes drug Actos [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 9]. Available from: www.gabionline.net/Generics/News/FDA-approval-for-generic-diabetes-drug-Actos

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Source: Actavis, Bloomberg, Watson