Complaint Alleges Bionpharma Is Infringing Azurity’s Epaned Patent

Azurity Pharmaceuticals, Inc. filed a lawsuit against Bionpharma, Inc with allegations that the company committed patent infringement when it filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA). 

The ANDA reportedly detailed Bionpharma’s plans to produce a generic version of Azurity’s successful oral solution product, Epaned. Azurity is seeking a judgement that the valid and enforceable patent was infringed, that the company will not gain approval or manufacture the drug before the expiration of the patent, and for additional relief as determined by the court.

Epaned, the drug produced by Azurity, is a “ready-to-use oral solution of enalapril maleate.” It is the only drug approved by the FDA that is an ace inhibitor treatment used as an oral solution for hypertension in children. The drug can also be used to treat hypertension in adults. The plaintiff claimed they received two separate letters from Bionpharma notifying Azurity of their intentions and the ANDA they had submitted to the FDA. The letters explained that the ANDA was filed in an effort to gain approval to “engage in the commercial manufacture, use, and sale of a generic version of Azurity’s Epaned product,” prior to the expiration of the patents involved.

Azurity claimed that Bionpharma has every intention to begin the manufacture and marketing of the drug as soon as approval is granted from the FDA, regardless of the patent. The patents surrounding Epaned, however, do not expire until 2036. Azurity maintains that the commercial manufacture of the product will “constitute an act of direct or indirect infringement on one or more claims of the ‘023 patent.” They also explained that it will cause “substantial and irreparable harm to Azurity for which damages are inadequate.” 

The complaint from Azurity also stated that the ANDA filed by Bionpharma has received tentative approval from the FDA. Bionpharma has countered the litigation from Azurity, stating that, “any further delay in the launch of Bionpharma’s ANDA is simply prejudicial to Bionpharma.”

Azurity closed their complaint by stating that, “upon FDA approval of Bionpharma’s ANDA product, Bionpharma will intentionally encourage acts of direct infringement with knowledge of the ‘023 patent and knowledge that its acts are encouraging infringement unless enjoined by the Court.” They are seeking favorable judgement that the patent was infringed upon, as well as an order enjoining Bionpharma from manufacturing the generic Epaned while the patent is still in place.

The plaintiff is represented by Saiber LLC.