US FDA approves first generic of AstraZeneca's Nexium

27 January 2015

The US Food and Drug Administration yesterday approved a generic version of Nexium (esomeprazole), Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) drug to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.

Ivax Pharmaceuticals, a US subsidiary of Israel-headquartered Teva Pharmaceuticals Industries (NYSE: TEVA), has gained approval to market esomeprazole in 20mg and mg. The approval is the first generic version of Nexium in the USA.

Nexium Delayed-Release Capsules, marketed by AstraZeneca, had annual sales of around $6 billion in the USA, according to IMS data as of November 2014, quoted by Teva. However, Nexium generated about $2.8 billion in global sales in the first nine months of 2014, of which $1.4 billion were in the USA, according to AstraZeneca's financial results report.

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