AbbVie Inc. and Allergan Pharmaceuticals International Limited v. Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc., No. 3:26-cv-14354 (D.N.J.), is a Hatch-Waxman patent complaint filed November 4, 2026. The complaint says AbbVie Inc., a Delaware corporation based in North Chicago, Illinois, holds NDA No. 215206 for QULIPTA (atogepant) tablets in 10 mg, 30 mg, and 60 mg strengths, which FDA approved on September 28, 2021, and that QULIPTA is approved for the preventive treatment of migraine in adults. It says Allergan Pharmaceuticals International Limited, an Irish company based in Dublin and an indirectly wholly owned subsidiary of AbbVie, is the assignee of the three patents. The complaint alleges, on information and belief formed after a reasonable inquiry, that Dr. Reddy's Laboratories, Ltd. is an Indian corporation based in Hyderabad, and that Dr. Reddy's Laboratories, Inc. is a New Jersey corporation based in Princeton, New Jersey, and a wholly owned subsidiary of the Indian company. Venue is pleaded under 28 U.S.C. §§ 1391 and 1400(b).
The patents and ANDA
The complaint asserts three patents, each titled Methods of Treating Migraine: U.S. Patent 12,622,897, issued May 12, 2026; U.S. Patent 12,661,341, issued June 23, 2026; and U.S. Patent 12,758,535, issued October 13, 2026. It says each currently expires on September 27, 2042. It says the '897 patent is listed in the Orange Book for the 10 mg and 30 mg tablets, that the '341 patent covers the 10 mg, 30 mg, and 60 mg tablets in the Orange Book, and that the '535 patent covers the 30 mg and 60 mg tablets in the Orange Book. Claim 1 of the '897 patent, whose wording a certificate of correction signed October 20, 2026 left unchanged when it renumbered the claims, covers a method for the preventive treatment of migraine in a patient undergoing concurrent treatment with an OATP inhibitor by orally administering a therapeutically effective dose of 10 mg atogepant once daily, wherein the patient's migraines are safely and effectively treated. Claim 1 of the '341 patent covers a method for the preventive treatment of migraine in a patient having mild or moderate hepatic impairment by orally administering 10 mg, 30 mg, or 60 mg atogepant once daily. Claim 1 of the '535 patent covers a method for the preventive treatment of episodic migraine in a patient undergoing concurrent treatment with a weak CYP3A4 inducer by orally administering a therapeutically effective dose of 30 mg atogepant once daily, wherein the patient's migraines are safely and effectively treated.
The complaint says Dr. Reddy's filed ANDA No. 221029 for atogepant oral tablets, 10 mg, 30 mg, and 60 mg, as generic versions of QULIPTA. It says a third notice letter from Dr. Reddy's, dated September 28, 2026, represents that the ANDA contains a Paragraph IV certification as to the '897 patent. It says plaintiffs have not yet received a Paragraph IV notice for the '341 or '535 patents, and alleges that the three notice letters, coupled with regulatory requirements, demonstrate infringement of those patents. It also says that because the notice letters do not indicate Paragraph IV certifications for four other Orange Book patents, U.S. Patents 8,754,096, 9,499,545, 9,850,246, and 10,117,836, Dr. Reddy's submitted Paragraph III certifications for them and will not launch a generic product under the ANDA at least before September 28, 2035. The complaint says plaintiffs filed this action within 45 days of receiving the third notice letter.
The counts
Count I alleges that the ANDA submission infringes the '897 patent under 35 U.S.C. § 271(e)(2)(A) and that, after FDA approval, Dr. Reddy's will infringe under § 271(a), (b), and/or (c). Count II seeks a declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that commercial manufacture, use, sale, offer for sale, or importation of the ANDA products before the '897 patent expires will infringe under § 271(a), (b), and/or (c). Counts III and IV plead the same theories for the '341 patent, and Counts V and VI for the '535 patent; for those two patents, the complaint says it provides notice to the extent Dr. Reddy's did not already have notice.
The prayer asks for judgments of infringement under § 271(e)(2)(A) and under § 271(a), (b), and/or (c); a declaration under 28 U.S.C. § 2201; an order under § 271(e)(4)(A) that any FDA approval of the ANDA be effective no earlier than patent expiration and exclusivity; permanent injunctions under §§ 271(e)(4)(B) and 283 against commercial activity and against seeking or maintaining ANDA approval before expiration; exceptional-case fees under §§ 285 and 271(e)(4); and further relief.
Related proceedings
The complaint says AbbVie and Allergan previously sued Dr. Reddy's in No. 3:25-cv-19039 (D.N.J.), filed December 29, 2025 in response to a notice letter dated November 17, 2025, and that case includes counts on U.S. Patents 12,090,148, 12,350,259, 12,383,545, and 12,465,598; a second notice letter dated April 6, 2026 concerned the '598 patent. It alleges, on information and belief, that Dr. Reddy's is maintaining its certifications as to those four patents, and says plaintiffs will continue to prosecute that case. The Local Rule 11.2 certification says those four patents are also the subject of Nos. 25-18972, 25-19038, 26-114, 26-115 (terminated), and 26-518 (D.N.J.); that the '897 and '341 patents are the subject of Nos. 26-10378, 26-10379, 26-11154, and 26-11156 (D.N.J.); and that the '535 patent is the subject of Nos. 26-10378, 26-10379, and 26-11156 (D.N.J.).
Docket
Through November 5, 2026, the docket shows the complaint, two corporate disclosure statements, and a notice of appearance on November 4, and the patent and trademark form (AO 120) and summons issued on November 5. Watch for service on the Dr. Reddy's companies, their answer, counterclaims, or a Rule 12 motion, and any motion to consolidate or coordinate this case with No. 3:25-cv-19039 or the other QULIPTA cases. The case can end at any time, including by settlement or voluntary dismissal.