Novo Nordisk Inc. and Novo Nordisk A/S filed Novo Nordisk Inc. et al. v. Dr. Reddy's Laboratories, Ltd. et al., No. 1:26-cv-12228 (D.N.J.), on September 16, 2026. Defendants are Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (together, DRL). The case is assigned to Judge Renee Marie Bumb.

Patents and accused products

The complaint asserts three Orange Book patents listed for Wegovy HD: U.S. Patents 11,318,191 (at least claims 1 and 15); 12,214,017 (at least claims 1 and 8); and 12,551,536 (at least claim 1). DRL's ANDA No. 221759 seeks approval of a generic semaglutide injection, 7.2 mg/0.75 mL for subcutaneous use, as a generic version of Wegovy HD under NDA No. 215256. Novo Nordisk received a Paragraph IV notice letter and sued under 35 U.S.C. § 271(e)(2).

What the patents cover

U.S. Patent 11,318,191 covers liquid GLP-1 / semaglutide compositions with limited phenol and a specified sodium chloride range, and related treatment methods. Asserted claims: at least claims 1 and 15. Claim 1 covers a liquid composition with 0.5 to 10 mg/mL semaglutide, 0.0% to 0.1% (w/w) phenol, and 8.2 to 8.9 mg/mL sodium chloride. Claim 15 covers treating diabetes, obesity, Alzheimer's disease, NASH, and/or cardiovascular disease by administering a therapeutically effective amount of that composition.

U.S. Patent 12,214,017 covers phenol-free (or essentially phenol-free) parenteral semaglutide compositions and obesity treatment methods. Asserted claims: at least claims 1 and 8. Claim 1 covers a liquid composition comprising semaglutide that does not contain phenol, is administered parenterally, meets aqueous or excipient limitations, has semaglutide in the 0.01 to 10.0 mg/ml range, and has pH between 7.0 and 7.4. Claim 8 covers treating obesity by administering a therapeutically effective amount of that composition.

U.S. Patent 12,551,536 covers using semaglutide in medical therapy for weight management. Asserted claims: at least claim 1. Claim 1 covers reducing body weight by administering semaglutide subcutaneously at 2.0 to 10.0 mg weekly.

What the lawsuit is about

Novo Nordisk ties DRL's ANDA product to the Wegovy HD 7.2 mg/0.75 mL formulation and label. It alleges the ANDA filing is statutory infringement under § 271(e)(2) of the three patents and that commercial launch would infringe composition and method claims, including through label-driven use. Novo Nordisk asks to delay FDA approval until patent expiry and for injunctive relief against the ANDA product.

What it means

This is a New Jersey Hatch-Waxman case on high-dose Wegovy HD semaglutide, focused on formulation (phenol / salt) and weekly high-dose weight-management method claims. Expect validity fights on the composition patents and claim-scope disputes over whether DRL's ANDA formula and proposed label map onto claims 1, 8, and 15 as pleaded.

What to watch next

Watch for DRL's answer and any early invalidity or noninfringement contentions. Also watch the 30-month stay clock tied to the ANDA Paragraph IV notice and whether related Wegovy / semaglutide cases are coordinated.