The complaint

The case is Supernus Pharmaceuticals, Inc. v. Ascent Pharmaceuticals Inc., Camber Pharmaceuticals, Inc., and Hetero Labs Limited, No. 2:26-cv-05942 (E.D.N.Y., Central Islip), filed and dated September 24, 2026, ECF No. 1. The docket shows the case assigned to Judge Gary R. Brown and Magistrate Judge Steven I. Locke. Supernus pleads six counts of patent infringement under 35 U.S.C. 271 arising from ANDA No. 221638, which, according to the complaint, seeks approval of viloxazine extended-release capsules in 100 mg, 150 mg, and 200 mg strengths. Supernus sells Qelbree, which the complaint describes as a selective norepinephrine reuptake inhibitor.

The patents

Three patents are titled Formulations of Viloxazine: U.S. Patents 9,358,204 (issued June 7, 2016), 9,603,853 (March 28, 2017), and 9,662,338 (May 30, 2017). Three are titled Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD): U.S. Patents 11,324,753 (May 10, 2022), 11,458,143 (October 4, 2022), and 12,121,523 (October 22, 2024). The complaint alleges Supernus owns all six, attaches them as Exhibits A to F, and says the FDA's Orange Book lists them for Qelbree. It pleads one count for each patent. (Compl. paras. 1, 57 to 63; U.S. Patents 9,358,204, 9,603,853, 9,662,338, 11,324,753, 11,458,143, and 12,121,523, first pages.)

What the lawsuit alleges

Supernus alleges, on information and belief, that Ascent is the named ANDA applicant, that Hetero is the parent of Ascent and Camber, and that the three companies work together to develop, manufacture, and sell the ANDA products. It alleges, on information and belief, that the defendants sent a Paragraph IV notice letter on or about August 13, 2026, and it alleges that the parties did not agree on terms for confidential access to the ANDA. It asks for judgments of infringement, an order that the effective date of any approval be no earlier than the patents' expiration, injunctive relief, and damages if commercial sales occur. (Compl. paras. 3 to 53; Counts One to Six; prayer.)

What to watch next

The latest docket entries, from September 25 and 28, 2026, are the issued summonses and Supernus's disclosure statement. Watch for the defendants' answers or motions and the Hatch-Waxman schedule.