Takeda Sues Zydus Over Proposed Generic EOHILIA.

Takeda Pharmaceuticals U.S.A., Inc. and ViroPharma Biologics LLC sued Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Ltd. in the District of New Jersey on September 30, 2026, No. 3:26-cv-12849, after Zydus filed ANDA No. 221618 for a generic version of EOHILIA, budesonide oral suspension 2 mg/10 mL, with a Paragraph IV certification. The complaint asserts two Orange Book patents. These are allegations.

The complaint

According to the complaint, Takeda Pharmaceuticals U.S.A. holds NDA No. 213976 for EOHILIA, a corticosteroid indicated for 12 weeks of treatment of eosinophilic esophagitis in adult and pediatric patients 11 years of age and older. The complaint says Zydus sent a Paragraph IV notice letter dated August 18, 2026, and that the suit was filed within 45 days of that letter. It pleads infringement of both patents under 35 U.S.C. 271(e)(2)(A) based on the ANDA submission and, if Zydus markets its product after approval, direct, induced, and contributory infringement of the '064 patent and induced and contributory infringement of the '934 patent.

The patents

Both asserted patents are titled Stable Corticosteroid Compositions, name Ramalingeswar Kasina as inventor, and issued to ViroPharma as assignee: U.S. Patent 11,260,064, issued March 1, 2022, and U.S. Patent 11,564,934, issued January 31, 2023. The complaint quotes claim 1 of each. Claim 1 of the '064 patent recites a pharmaceutical composition for oral administration comprising budesonide; an antioxidant, from about 0.05% to about 0.5% w/w of the composition, that comprises a combination of ascorbic acid and a pharmaceutically acceptable salt of ascorbate; and a flavoring agent, a sweetener, or a combination of them, with less than 0.3% impurities formed by oxidative degradation. Claim 1 of the '934 patent recites a method of treating eosinophilic esophagitis, or alleviating its symptoms and inflammation, by administering a budesonide composition with the same antioxidant and impurity limitations.

The related Lupin case

The complaint's local-rule certification says the case is related to Takeda Pharmaceuticals U.S.A., Inc. v. Lupin, Ltd., No. 25-12574 (D.N.J.), because it involves the same plaintiffs, the same patents, and defendants seeking approval to market a generic version of the same drug product.

Relief requested

The prayer asks for an order that the effective date of any approval of ANDA No. 221618 be no earlier than the expiration of the patents or any later exclusivity, preliminary and permanent injunctions, damages for any commercial activity before the patents expire, a judgment that the patents remain valid, and attorneys' fees under 35 U.S.C. 285. These are requests. The court has not granted them.

What to watch next

Under 21 U.S.C. 355(j)(5)(B)(iii), a suit brought within 45 days after the patent owner receives a Paragraph IV notice generally delays the effective date of FDA approval for 30 months from receipt of the notice, subject to exceptions, including an earlier court decision that the patent is invalid or not infringed. Watch for Zydus's answer and any counterclaims, and for coordination with the Lupin case. The case can end at any time by settlement or dismissal.