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Ranbaxy’s manufacturing woes benefit big pharma

Generics/General | Posted 22/08/2014 0 Post your comment

Import bans by the US Food and Drug Administration (FDA) on generics from four of Ranbaxy Laboratories’ (Ranbaxy) manufacturing sites have prevented the company from launching new generics, allowing brand-name manufacturers to benefit from their extended monopolies.

Ranbaxy received import bans at its Dewas, Mohali, Paonta Sahib and Toansa sites for good manufacturing procedure (GMP) violations [1]. This has prevented the company from launching at least three generics in the US on time, which would have come with 180 days of exclusivity. Hence, brand-name drug companies were allowed to sell expensive products despite the expiry of patent protection on their products.

The drugs that have benefitted from Ranbaxy’s manufacturing woes include AstraZeneca’s acid reflux drug, Nexium (esomeprazole), high blood pressure treatment Diovan (valsartan) from Novartis and Roche’s cytomegalovirus treatment Valcyte (valganciclovir).

It has been estimated that – in the absence of generics competition – Nexium, Diovan, and Valcyte had combined sales in the US of around US$8 billion in 2013. This is good news for the brand-name manufacturers but not such good news for US patients who had to pay more for their drugs when there should have been a generic drug alternative available.

Ranbaxy only managed to launch its generic version of Diovan in July 2014, despite the fact that the patent on Diovan expired in September 2012. Ranbaxy is yet to launch its generic version of Valcyte, though it was expected in March 2013 under a settlement agreement with Roche. Ranbaxy is also yet to launch its generic version of Nexium after making an agreement with AstraZeneca to launch on 27 May 2014, after the expiry of the 5,877,192 and 6,875,872 patents on Nexium.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues Ranbaxy with Form 483 for violations at Toansa plant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 22]. Available from: www.gabionline.net/Generics/News/FDA-issues-Ranbaxy-with-Form-483-for-violations-at-Toansa-plant

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