The complaint

Baxter Healthcare Corp., Baxter International Inc. and Baxter Healthcare SA v. InfoRLife SA, No. 2:26-cv-11835 (D.N.J.), is a sixteen-page patent complaint filed September 11, 2026, ECF No. 1. Baxter alleges that InfoRLife submitted supplemental NDA No. 215700 under Section 505(b)(2), relying on investigations in Baxter's NDA No. 214313, seeking approval to sell Norepinephrine Bitartrate in 5% Dextrose Injection at 16, 32, 64, and 128 mcg/mL before the patents expire, with paragraph IV certifications to both patents. Baxter alleges that InfoRLife's notice letter is dated July 30, 2026, that Baxter sought confidential access to the application without a substantive response, and that it filed within 45 days of receiving the letter.

What the patents cover

U.S. Patent 12,097,170, titled Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation, issued September 24, 2024. Claim 1 covers a packaged, sealed container system holding a ready-to-use norepinephrine formulation of 0.015 mg/ml to about 0.035 mg/ml norepinephrine, as norepinephrine bitartrate monohydrate, with dextrose and a pH between 3.4 and 4.0, free of an antioxidant and without sodium chloride. The primary container is a multi-layer bag with low-density polyethylene, polypropylene, and middle polyamide layers; it sits inside a secondary container of two sealed flexible sheets, one a coextruded film including a metal foil and the other colored to protect the formulation from light, together with an oxygen scavenger. The claim also requires a dissolved oxygen level below 0.5 ppm after at least 150 days at 25° C. and retention of at least about 90% of initial activity after at least 120 days at 25° C.

U.S. Patent 12,290,494 has the same title and issued May 6, 2025. Its claim 1 covers a similar system with about 0.015 mg/ml to about 0.035 mg/ml norepinephrine, in which the primary container is an intravenous (IV) bag and the secondary container is two sealed flexible sheets enclosing the bag and an oxygen scavenger, with the same formulation, dissolved oxygen, and stability limits.

What the lawsuit is about

Baxter alleges that it launched its product in September 2021 as the first and only ready-to-use premixed norepinephrine in dextrose product in the United States, that both patents are listed in the Orange Book for that product, and that Baxter International Inc. and Baxter Healthcare SA are the assignees. Each of the two counts alleges infringement under 35 U.S.C. 271(e)(2)(A) and future infringement under 35 U.S.C. 271(a), (b), and (c). The prayer asks for judgments that the patents are valid and infringed, an order under 35 U.S.C. 271(e)(4)(A) delaying the effective date of any approval until the patents expire, injunctions, damages for any commercial sales, and attorneys' fees.

What to watch next

InfoRLife answered the complaint and filed counterclaims on October 27, 2026 (ECF No. 10), and on October 29, 2026 the court entered an order setting a hearing (ECF No. 14). Watch for the scheduling conference and the case schedule, and for FDA action on the supplemental NDA.