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Dr Reddy’s faces temporary sales ban on generic esomeprazole Posted 27/11/2015

A US court has temporarily banned Dr Reddy’s Laboratories from selling its generic version of AstraZeneca’s heartburn drug Nexium (esomeprazole) in the US over allegations of trademark infringement.

UK-based pharma giant AstraZeneca complained about the use of the colour purple for Dr Reddy’s generic pills, saying it encroached on its trademarks.

On 10 November 2015, the US District Court for Delaware imposed a temporary restraining order on Dr Reddy’s ‘sales, delivery, transfer, or other disposition of its generic esomeprazole product in the US market with immediate effect’.

The court pointed out that AstraZeneca has used the colour purple for its gastrointestinal products [Nexium and Prilosec (omeprazole)] since 1989. In addition, AstraZeneca has three federal trademark registrations covering the colour purple, which also cover the name ‘The Purple Pill’.

The court also said that if Dr Reddy’s arguments were carried to the logical end, the loss of a brand-name company’s patent monopoly would inevitably result in a loss of its trademark rights, ‘a result not consistent with the law or the market place’.

This could cause a problem for the US Food and Drug Administration (FDA), which issued guidance in June 2015 recommending that the physical properties, including the size, shape and colour, of generics should be similar to those of their reference drugs [1].

The US court order is pending a further hearing or trial, and the court has asked both companies to suggest the next course of action.

Dr Reddy’s said that it is complying with the order and evaluating all possible options to resolve the matter at the earliest possibility.

FDA approved the first generic version of Nexium (esomeprazole) delayed-release capsules in January 2015 [2]. Despite competition from generics Nexium still made about US$1.93 billion in sales for AstraZeneca in the nine months to September 2015.

Related article
FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs

References
1.    GaBI Online - Generics and Biosimilars Initiative. FDA wants generics to be physically same as originators [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 27]. Available from: www.gabionline.net/Guidelines/FDA-wants-generics-to-be-physically-same-as-originators
2.    GaBI Online - Generics and Biosimilars Initiative. FDA approves first generic esomeprazole [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 27]. Available from: www.gabionline.net/Generics/News/FDA-approves-first-generic-esomeprazole

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Source: Dr Reddy’s,Economic Times India, Reuters

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