Dublin-based Endo Ventures Limited has filed a civil lawsuit against Lincolnshire, Illinois-based Nexus Pharmaceuticals, Inc. following allegations that Nexus has infringed on a patent previously obtained by Endo. Nexus has a 100,000-square-foot manufacturing facility in Pleasant Prairie.
The federal lawsuit, filed this week in U.S. District Court for the Eastern District of Wisconsin, states Endo obtained a patent in December of 2020 for “Ephedrine Compositions and Methods.” Endo also has a new drug application for 5 mg/ML ephedrine sulfate injections in glass vials, according to the complaint. These injections were approved by the FDA in October of 2020 and an affiliate of Endo, Par Sterile, began making them last March.
The complaint further states that Nexus also holds a new drug application for 5 mg/ML ephedrine sulfate injections in glass vials, which gained FDA approval on Aug. 2021. After gaining approval for the product, Nexus filed a complaint in New Jersey in 2020 seeking a declaratory judgment that the company’s Emerphed Ready-To-Use (RTU) Vials do not infringe on Endo Ventures’ patent.
Court records show the lawsuit filed in New Jersey was settled between both companies and dismissed.
Nexus’ Emerphed RTU Syringes gained FDA approval this March. A patent covering certain applications of Emerphed RTU Syringes was issued by the United States Patent and Trademark Office in August 2021. Nexus has since earned several additional patents on its Emerphed line of vials and syringes and continues to pursue further patent protection related to Emerphed.
“On October 17, 2022, counsel for Endo and Par Sterile contacted counsel for Nexus and requested confidential access to regulatory filings related to Nexus’s Emerphed RTU Syringes,” reads the complaint. “On October 26, 2022, counsel for Nexus declined that request and asserted that Nexus has no obligation to disclose to Endo any information regarding any of its products or potential products.”
Endo is seeking a judgement declaring Nexus has infringed directly on its patent and an order stopping the company from continuing to sell its Emerphed RTU Syringes. Endo is also seeking compensatory damages and the reimbursement of court costs.
Nexus Pharmaceuticals declined to comment on the pending litigation.