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28 October 2021AmericasMuireann Bolger

Azurity hits manufacturer with suit over hypertension drug patents

Azurity Pharmaceuticals has sued Florida-based generic manufacturer  CoreRx for infringing a pair of patents covering a hypertension drug for children.

The company filed the  complaint on Wednesday, October 27, at the  US District Court for the District of Delaware.

The dispute concerns US patent numbers 11,040,023  and 11,141,405, which cover  Epaned (enalapril maleate), a ready-to-use oral solution hypertension drug for children under the age of six.

Epaned is also indicated to treat hypertension in adults, heart failure, and asymptomatic left ventricular dysfunction. Both patents were issued this year, and are not due to expire until March 2036.

Azurity held that CoreRx infringed with the production and manufacture of its CoreRx Formulation, which is also the alleged infringing product at issue in two other pending litigations in the federal court of Delaware against Bionpharma.

The pharmaceutical company alleged that the formulation formed the basis of Bionpharma’s Abbreviated New Drug Application to produce a generic of Epaned that was later approved by the  US Food and Drug Administration in August.

In 2018, Bionpharma entered a contractual  agreement with CoreRx to develop, manufacture and supply generic drugs to be owned and sold by Bionpharma under its label.

Azurity brought an action against Bionpharma for infringement of the 023 patent in August, followed by another  infringement suit over the’405 patent in October.

Azuirity has requested a jury trial against CoreRx, and a judgment that the manufacturer has induced infringement of the patents-in-suit by encouraging others, including Bionpharma, to use, sell, offer for sale, and/or import the CoreRx Formulation in the US before the expiration of the patents.

In April, Azurity's subsidiary Silvergate Pharmaceuticals failed to convince the federal court in Delaware that Bionpharma’s generic would infringe other patents covering Epaned.

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