nexium
Courtesy of AstraZeneca
4 August 2014Americas

AstraZeneca sues Zydus to protect Nexium

Anglo-Swedish pharmaceutical company AstraZeneca has sued India-based Zydus for infringing three patents related to its heartburn drug Nexium (esomeprazole magnesium).

AstraZeneca filed the case last Thursday, July 31, at the US District Court for the District of New Jersey, after Zydus submitted an Abbreviated New Drug Application (ANDA) seeking permission from the US Food and Drug Administration to market a esomeprazole magnesium delayed-release tablets.

In its ANDA Notice Letter to AstraZeneca, Zydus argued that the patents are invalid and unenforceable.

AstraZeneca holds the New Drug Application for Nexium in 20 mg and 40 mg doses. In the case, it asserts three patents, 6,369,085, 7,411,070 and 8,466,175, that cover the drug’s active ingredient, processes for preparing the drug’s active ingredient, and methods of treating Helicobacter infections.

Helicobacter pylori is a bacteria linked to the development of gastritis and dyspepsia.

All three of the asserted patents are due to expire in 2018.

AstraZeneca has asked for a judgment that the patents are valid and enforceable, that Zydus’ ANDA infringes claims in each of the patents, and for a permanent injunction stopping Zydus from making or selling generic esomeprazole magnesium products before expiration of the patents.

Nexium, which is available over the counter in the US, made US sales of $455 million in the second quarter of 2014.

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