Although market exclusivity has expired for the OTC version of Nexium it licensed to Pfizer, AstraZeneca filed litigation to block Perrigo from marketing a generic of the OTC before its patent for the PPI expires on May 25, 2018. The dispute was settled, though, in a settlement that was approved and ordered sealed in June.

AstraZenca alleged in the complaint it filed in February 2015 in US District Court for the New Jersey District that Perrigo’s ANDA to FDA for an esomeprazole 20 mg delayed-release capsule included a certification alleging the Nexium patent is invalid, unenforceable or will not be infringed by its manufacture and sale of its product.

However, Perrigo’s letter informing AstraZeneca of the filing “constitutes infringement of one or more claims of the [Nexium] patent, either literally or under the doctrine of equivalents,” according to the complaint filed by attorneys with McCarter & English LLP, of Newark, N.J., working with attorneys with Covington & Burling LLP, of Washington.

The patent described the composition of Nexium’s active ingredient, magnesium salts of esomeprazole trihydrate, methods of treatment using the ingredient and processes for preparing it.

In her order approving the settlement, Judge Mary Cooper said the firms crafted an agreement that enjoins Perrigo from infringing the patents. Cooper dismissed with prejudice AstraZeneca’s complaint and Perrigo’s counter-complaint filed as a defense “without costs, disbursements or attorneys’ fees to any party.”

Perrigo Draws On OTC Strength For Private Label Nexium 24HR Launch

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