Aurobindo gets USFDA final nod for generic Nexium

The approved drug has an estimated market size of $4.2 billion for twelve months ending February, 2016

Aurobindo Pharma Limited announced today the company has received final approval from the US Food and Drug Administration(US FDA) to manufacture and market Esomeprazole Megnesium Delayed-release capsules of 20 mg and 40 mg. The drug is the generic equivalent of Nexium owned by AstraZeneca Pharmaceuticals LLP.

The launch of this product is based on the settlement terms/litigation outcome with AstraZeneca, the company said.

In December last year Dr Reddy's Laboratories Limited had relaunched the Esomeprazole Megnesium product in the US market after withdrawing the drug from market due to a brief legal dispute with AstraZeneca over the usage of colour purple.

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The product is used in the treatment of Gastroesophageal reflux disease (GERD). The approved drug has an estimated market size of $4.2 billion for the twelve months ending February, 2016 according to IMS Health data.

This is the 70th ANDA (abbreviated new drug application) to be approved out of Aurobindo's Unit-7 formulation facility, located in Hyderabad.

Global generic companies such as Teva, Mylan, Chamber Pharmaceuticals have already launched their generic versions of Nexium in the US market last year.

Following the patent expiry, Ranbaxy Laboratories was first granted the 180-day marketing exclusivity for the Nexium generic drug but the same was forfeited by US FDA in January, 2015 citing the pending compliance issues involving a couple of manufacturing facilities of the drug major. Ranbaxy Laboratories later merged with Sun Pharma.