Incyte Corp. and Incyte Holdings Corp. v. Granules India Ltd., No. 1:26-cv-14402 (D.N.J.), is a Hatch-Waxman patent complaint filed November 5, 2026. The complaint says Incyte Corporation and Incyte Holdings Corporation are Delaware corporations based in Wilmington, Delaware, that the patents are owned by Incyte Corporation and/or Incyte Holdings Corporation, and that Incyte Corporation holds NDA No. 217180 for Jakafi XR (ruxolitinib extended-release). The FDA Orange Book lists NDA 217180 for Jakafi XR with an approval date of May 1, 2026. It alleges, on information and belief, that Granules India Ltd. is an Indian corporation based in Hyderabad, India. Subject matter jurisdiction is pleaded under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202, and venue under 28 U.S.C. §§ 1391 and/or 1400(b), on the ground that Granules is organized under the laws of India and may be sued in any judicial district.

The ANDA and the patents

The complaint says Granules submitted ANDA No. 221826 seeking approval of generic versions of Jakafi XR tablets in 11 mg, 22 mg, 33 mg, 44 mg, and 55 mg strengths before the patents expire, with Paragraph IV certifications that the patents are invalid and/or will not be infringed, and that Granules sent Incyte written notice of those certifications. It says the patents are listed in the Orange Book with respect to Jakafi XR. Each patent is titled Sustained-Release Dosage Forms of Ruxolitinib: U.S. Patent 10,874,616, issued December 29, 2020; U.S. Patent 11,337,927, issued May 24, 2022; U.S. Patents 11,576,864 and 11,576,865, both issued February 14, 2023; and U.S. Patent 11,896,717, issued February 13, 2024.

What the complaint alleges

The complaint quotes an October 7, 2026 Granules press release announcing a Paragraph IV certification for its ruxolitinib extended-release tablets and stating that Granules believes it is eligible for first-to-file status. It says the notice letter's offer of confidential access would not allow a full investigation of the ANDA, that Incyte wrote to Granules on October 5, 2026, Granules responded on October 19, 2026, and Incyte responded on October 30, 2026, but that the parties were not able to reach an agreement on access before the time period set by 21 U.S.C. § 355(j)(5)(B)(iii) expired, and that Incyte therefore makes its allegations on information and belief. For personal jurisdiction it points to Granules's business in New Jersey through U.S. subsidiaries and to Granules's consent to jurisdiction in earlier cases, including No. 25-13227 (D.N.J.), which it describes as litigation between these parties over a generic version of Jakafi, and No. 25-14606 (D.N.J.).

The counts and relief

Counts I through V, one for each patent, allege infringement under 35 U.S.C. § 271(e)(2)(A) through the ANDA submission, and allege that upon FDA approval Granules will infringe under § 271(a), induce infringement under § 271(b), and contribute to infringement under § 271(c), with the inducement and contributory knowledge and intent allegations made on information and belief. Each count alleges an exceptional case under § 285. The prayer asks for judgments of infringement; an order under § 271(e)(4)(A) that FDA approval of ANDA No. 221826 be effective no earlier than the expiration of the patents or any later exclusivity; preliminary and permanent injunctions, including a permanent injunction under § 271(e)(4)(B); damages for any acts outside § 271(e)(1) or any commercial activity before expiration; a judgment that the patents remain valid and enforceable; an exceptional case finding with attorneys' fees; costs and expenses; and other relief.

Docket

The complaint's certification under Local Civil Rules 11.2 and 40.1 says the matter in controversy is the subject of an action pending in the Eastern District of Texas, No. 2:26-cv-00999, and is not the subject of any other pending action, arbitration, or administrative proceeding. The docket record lists the case as assigned to Judge Edward S. Kiel. The docket shows the complaint and a corporate disclosure statement on November 5, 2026, and on November 6, 2026 the AO 120 patent form, summons issued, an entry adding and terminating judges, and a notice of judicial preferences. Watch for service on Granules, its answer, counterclaims, or a Rule 12 motion, and any motion addressing the parallel No. 2:26-cv-00999 (E.D. Tex.). The case can end at any time, including by settlement or voluntary dismissal.