Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity

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Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity

Generics/News | Posted 26/10/2012 0 Post your comment

US-based Mylan has sued FDA for refusing to grant approval to sell a generic version of Novartis’s heart treatment, Diovan HCT (valsartan/hydrochlorothiazide), ‘after a competitor failed to get the drug on the market in time’.

Ranbaxy Laboratories (Ranbaxy) was the first company to file an abbreviated new drug application (ANDA) for its generic version of Novartis’ Diovan HCT (valsartan/hydrochlorothiazide) gaining the Indian generics giant 180-days of exclusive marketing rights for its generic drug.

Ranbaxy was scheduled to launch its generic drug on 21 September 2012, the day Diovan’s patent expired, however, as yet Ranbaxy has failed to launch, due to lack of approval of its ANDA by FDA. Mylan, on the other hand, announced on 21 September 2012, FDA’s approval for its generic version of Diovan [1].

In a lawsuit filed on 2 October 2012 in a federal court in Washington DC, USA, Mylan said that Ranbaxy had ‘forfeited its right to six-months exclusivity to sell the generic drug by not winning FDA approval’. Mylan argues that ‘FDA’s refusal to approve its sale of the drug is arbitrary and capricious and an abuse of discretion’. FDA spokesperson Mrs Sandy Walsh refused to comment on the matter, telling Bloomberg that ‘the agency doesn’t comment on pending litigation’.

If Mylan wins the case, FDA may have to open doors for other generics drugmakers seeking approval for their generic versions of Diovan HCT. However, similar litigation by Mylan concerning Ranbaxy’s 180-day exclusivity for a generic version of Pfizer’s cholesterol-lowering treatment Lipitor (atorvastatin) was rejected by a federal court in Washington DC, USA, in May 2011 [2].

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References

1. GaBI Online - Generics and Biosimilars Initiative. Mylan debuts first generic Diovan HCT and Antivert in USA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 26]. Available from: http://www.gabionline.net/Generics/News/Mylan-debuts-first-generic-Diovan-HCT-and-Antivert-in-USA

2. GaBI Online - Generics and Biosimilars Initiative. Mylan’s attempt to stop Ranbaxy’s Lipitor exclusivity fails [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 26]. Available from: www.gabionline.net/Generics/News/Mylan-s-attempt-to-stop-Ranbaxy-s-Lipitor-exclusivity-fails

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Source: Bloomberg