Incyte Corporation and Incyte Holdings Corporation filed Incyte Corp. v. Granules India Ltd., No. 2:26-cv-00999 (E.D. Tex., Marshall Division), on November 4, 2026. The complaint says Granules submitted ANDA No. 221826 to the FDA seeking approval of generic versions of Jakafi XR (ruxolitinib extended-release) tablets in 11 mg, 22 mg, 33 mg, 44 mg, and 55 mg strengths before the asserted patents expire. Incyte Corporation holds NDA No. 217180 for Jakafi XR. The FDA Orange Book lists NDA 217180 for Jakafi XR with an approval date of May 1, 2026. The complaint describes Granules, on information and belief, as an Indian company based in Hyderabad. The case is assigned to District Judge Rodney Gilstrap and referred to Magistrate Judge Roy S. Payne.
The patents
The complaint asserts five patents, each titled "Sustained-Release Dosage Forms of Ruxolitinib" and each listed in the Orange Book for Jakafi XR: U.S. Patents 10,874,616 (issued December 29, 2020); 11,337,927 (issued May 24, 2022); 11,576,864 (issued February 14, 2023); 11,576,865 (issued February 14, 2023); 11,896,717 (issued February 13, 2024).
What the complaint alleges
The complaint says Granules's ANDA includes Paragraph IV certifications that the patents are invalid or will not be infringed, and that Granules sent Incyte a notice letter. It quotes an October 7, 2026 Granules press release announcing the Paragraph IV filing 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. Venue is pleaded on the ground that Granules is a foreign company, with personal jurisdiction based in part on sales in Texas through U.S. subsidiaries, alleged on information and belief.
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.
Relief requested
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, a permanent injunction under § 271(e)(4)(B), damages for any acts outside § 271(e)(1) or any launch before expiration, a declaration that the patents remain valid and enforceable, an exceptional case finding with attorneys' fees, costs, and other relief.
Where the case stands
The docket shows the complaint, a disclosure statement, the AO 120 patent form, a request for issuance of summons, a summons issued, and a November 4, 2026 case assignment entry. Watch for service on Granules and its answer or a motion.