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Baxter Healthcare Corp., et al. v. PH Health Ltd., et al., No. 2:25-cv-15120 (D.N.J.)
Haug Partners LLP is pleased to announce a complete victory for its client Baxter Healthcare Corporation in Hatch-Waxman patent litigation concerning Baxter’s NEXTERONE® (amiodarone HCl) Premixed Injection. NEXTERONE® is the first and only ready-to-use, premixed intravenous formulation of amiodarone, an antiarrhythmic used to treat life-threatening ventricular arrhythmias—including recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
PH Health, the first ANDA filer, initially challenged a single patent—U.S. Patent No. 7,635,773 (the “’773 patent”)—directed to the high-purity sulfoalkyl ether cyclodextrin (Captisol®) technology that makes the NEXTERONE® formulation possible. This year, Baxter strengthened its position by listing additional CyDex patents in the FDA’s Orange Book for NEXTERONE®—U.S. Patent Nos. 8,410,077, 9,200,088, 9,493,582, 9,750,822, and 10,117,951.
Shortly after Baxter served its infringement contentions in the District of New Jersey, the Defendants converted their Paragraph IV certifications to Paragraph III certifications as to the ’773 patent and submitted PIII certifications for each of the newly listed patents. The result fully preserves Baxter’s exclusivity and vindicates the patent rights of Baxter and its co-plaintiff CyDex Pharmaceuticals, Inc.
The Haug Partners team representing Baxter included Edgar H. Haug, Kaitlin M. Farrell, Andrew S. Roper, and Andrew S. Wasson.
A copy of the stipulation and order of dismissal can be found here.