Teva gets OK for first US generic of AZ’s Nexium

AstraZeneca will finally face generic competition for Nexium now Teva Pharmaceutical Industries has received the green light in the USA for its version of the blockbuster antiulcerant.

The Israeli drugmaker noted that the Food and Drug Administration has granted it approval for the first generic equivalent to Nexium (esomeprazole) across the pond. The therapy, which lost patent protection in the USA last May, had annual sales of around $6 billion in the country, according to IMS data.

Teva says it is “preparing to launch the product in the near future”, which is a further blow to Ranbaxy Laboratories which was the first-to-file an abbreviated New Drug Application for generic Nexium which would have entitled the company to 180 days of generic market exclusivity.

However, ongoing disputes with the FDA over manufacturing issues at its Indian facilities mean that Ranbaxy imports from certain sites have been banned and the branded product remained the only one on the US market. Last month, a US court backed AstraZeneca concerning a pay-for-delay agreement with Ranbaxy to delay the launch of generic Nexium, saying the reportedly $1 billion pact did not break competition laws.

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