The complaint

Takeda Pharmaceutical Company Limited v. Sun Pharmaceutical Industries Ltd., No. 2:26-cv-11870 (D.N.J.), is an eleven-page patent complaint filed September 11, 2026, ECF No. 1. Takeda alleges that Sun submitted ANDA No. 219690 seeking approval to market maribavir tablets, 200 mg, as a generic version of LIVTENCITY® before the '368 patent expires. It alleges, on information and belief, that Sun made a Paragraph IV certification in connection with that ANDA, and it alleges that Sun sent a notice letter dated July 29, 2026. The complaint alleges, on information and belief, that Sun is organized under the laws of India. The docket's assignment entry shows the case assigned to Judge Esther Salas and Magistrate Judge Alex D. Silagi.

Takeda's Local Civil Rule 11.2 and 40.1 certification identifies as related other District of New Jersey suits over generic LIVTENCITY, Nos. 26-9729, 26-1780, and 26-1633 (consolidated), and two earlier Takeda suits against Sun, Nos. 26-4939 and 26-2051.

What the patent covers

U.S. Patent 12,661,368 is titled Maribavir isomers, compositions, methods of making and methods of using, and issued June 23, 2026. Claim 1 covers a method of treating a cytomegalovirus (CMV) infection by orally administering 5,6-dichloro-2-(isopropylamino)-1-(β-L-ribofuranosyl)-1H-benzimidazole at 400 mg twice a day in a composition with a therapeutically acceptable adjuvant, excipient, or carrier medium, where the composition is an immediate release formulation that releases the compound by dissolution in less than 60 minutes.

What the lawsuit is about

Takeda alleges that LIVTENCITY® is a cytomegalovirus pUL97 kinase inhibitor, that the '368 patent is listed in the Orange Book for it, and that the product's labeling instructs administration according to the claimed methods. The single count alleges that Sun's ANDA submission infringes under 35 U.S.C. 271(e)(2)(A) and that marketing after approval would infringe and induce and contribute to infringement. The prayer asks for an order under 35 U.S.C. 271(e)(4)(A) that the effective date of any approval be no earlier than the patent's expiration, preliminary and permanent injunctions, a declaration that the patent remains valid, damages for any commercial acts, and attorneys' fees.

What to watch next

Sun answered the complaint and filed a counterclaim on October 15, 2026 (ECF No. 8). On October 19, 2026 the court entered an order (ECF No. 13) that the docket describes as creating a case association, and the docket marks this case terminated the same day. Watch the related maribavir dockets for where the claims proceed.