On Thursday in the District of New Jersey, Azurity Pharmaceuticals Inc. filed a complaint against Amneal Pharmaceuticals LLC alleging that a product the defendant intends to manufacture and sell infringes on the plaintiff’s patents covering the drug Katerzia.
The plaintiff is the assignee of United States Patent Nos. 10,695,329; 10,799,453; 10,894,039; and 10,952,998, all listed in the Food and Drug Administration (FDA)’s patent database, Orange Book, as covering Katerzia. Katerzia is meant for treating hypertension in adults and children ages 6 and older as well as for coronary artery diseases, such as chronic stable angina, vasospastic angina, and angiographically documented coronary artery disease for patients not experiencing heart failure, the complaint detailed.
According to the complaint, generic drug company Amneal submitted Abbreviated New Drug Application (ANDA) No. 215035 to the FDA to gain approval for the generic version of Katerzia, amlodipine, and alerted Azurity that it had done so via a letter dated Feb. 23.
“By filing ANDA No. 215035, Amneal has necessarily represented to FDA that the Amneal ANDA Product has the same active ingredient as Azurity’s Katerzia® product, as well as the same dosage form, route of administration, use, and strength as Azurity’s Katerzia® product, and that it is bioequivalent to Azurity’s Katerzia® product,” the complaint said.
Azurity claimed that Amneal “had actual and constructive knowledge” of the patents-in-suit and “specific intent to infringe” the patents upon submitting its ANDA.
According to the plaintiff, if Amneal is not enjoined from continuing its allegedly infringing conduct, Azurity will suffer “irreparable harm.” Azurity is requesting a declaration that its patents are valid and enforceable; a judgment that Amneal’s behavior indeed constitutes infringement; a finding that this case is “exceptional,” thus warranting attorney’s fees and costs; and any other reasonable relief.
Saiber LLC is representing Azurity.
