Azurity sues Bionpharma over newly issued patent

Azurity Pharmaceuticals has sued Massachusetts drug company Bionpharma, claiming that its generic of Azurity’s Epaned product infringes on a brand new patent.

Epaned (enalapril maleate) is a ready-to-use oral solution hypertension drug for children under the age of six.

The drug, which has been available by prescription in the US since November 2013, is the only Food and Drug Administration (FDA) approved and labeled ace inhibitor treatment of its kind, according to Azurity.

Only three days after securing a patent protecting the formulation of Epaned on 12 October, Azurity filed a complaint against Biopharma with the US District Court for the District Of Delaware on Friday 15 October.

The complaint says that Bionpharma’s generic, which received FDA approval earlier this year, infringes on the newly minted patent.

The complaint requests that the court rescind the final FDA approval of Bionpharma’s Abbreviated New Drug Application and to block the sale of the drug in the US until the patent expires.

Bionpharma received final approval of its ANDA from the FDA on August 10, 2021, and has been manufacturing and selling the generic since according to the complaint.

Azurity’s patent—US patent 11,141,405—is titled “Enalapril formulations” and was filed on 15 January 2021 and is set to expire on 25 March, 2036.

Azurity also filed a complaint in the same Delaware court in June, claiming that Bionpharma’s ANDA infringes a separate Epaned formulations patent, US patent 11,040,023.

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