Pharmacosmos Sues Dr. Reddy's on a New Trilaciclib Crystal Form Patent Over a Generic Cosela ANDA.

The case

Pharmacosmos A/S, Pharmacosmos Holding A/S, and Pharmacosmos Therapeutics Inc. v. Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd., No. 2:26-cv-14266 (D.N.J.), is a 19-page complaint filed November 2, 2026, Document 1. Pharmacosmos A/S and Pharmacosmos Holding A/S are Danish companies based in Holbaek, Denmark, and Pharmacosmos Therapeutics Inc. is a Delaware corporation based in Morristown, New Jersey. The complaint alleges, on information and belief, that Dr. Reddy's Laboratories, Ltd. is organized under the laws of India and 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(c)(3) as to the Indian company and 28 U.S.C. § 1400(b) as to the New Jersey company.

The drug, the ANDA, and the earlier case

The complaint says Pharmacosmos A/S holds NDA No. 214200 for Cosela (trilaciclib) for injection, approved February 12, 2021, and that its new chemical entity exclusivity expired February 12, 2026. It says a letter dated March 24, 2025 gave notice that ANDA No. 220230, for a 300 mg base per vial generic trilaciclib product, contains a Paragraph IV certification as to Orange Book patents for Cosela, including U.S. Patent 12,168,666. Pharmacosmos then sued Dr. Reddy's in No. 2:25-cv-03967 (D.N.J.), which the complaint says is consolidated with No. 2:25-cv-03218 (D.N.J.) and asserts the '666 patent.

The complaint says the '404 patent is a continuation of the application that issued as the '666 patent, shares its expiration date, and issued after the earlier case was filed. It says Pharmacosmos asked on October 9, 2026 for consent to amend its complaint in the earlier case to add the '404 patent, and that Dr. Reddy's responded on October 30, 2026 that it would consent only on conditions that included dismissing claims on other patents asserted there, which Pharmacosmos found unacceptable. It also says Pharmacosmos asked on October 14, 2026 for access to ANDA product samples and data from the earlier case.

The patent

U.S. Patent 12,497,404, titled Morphic forms of trilaciclib and methods of manufacture thereof, issued December 16, 2025. The complaint says Pharmacosmos Holding A/S is the assignee, Pharmacosmos Therapeutics Inc. holds an exclusive license to commercialize Cosela in the United States, and the patent expires November 13, 2040. Claim 1 covers a crystalline compound, defined by a drawn chemical structure, that is a dihydrochloride characterized by an X-ray powder diffraction pattern with at least three 2theta values selected from 8.1, 14.8, 16.5, 18.1, 19.7, 24.8, and 27.7 degrees, each plus or minus 0.2. The complaint alleges, on information and belief, that the ANDA product contains crystalline trilaciclib dihydrochloride meeting every limitation of at least claim 1.

Counts and relief

Count I alleges infringement of the '404 patent under 35 U.S.C. § 271(e)(2)(A) by submitting the ANDA, with both Dr. Reddy's companies alleged to be jointly and severally liable. Count II seeks a declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that making, using, selling, offering to sell, or importing the ANDA product before the patent expires will infringe under 35 U.S.C. § 271(a), (b), and/or (c).

The prayer asks for a judgment of infringement under § 271(e)(2)(A); the declaratory judgment; a permanent injunction under 35 U.S.C. § 271(e)(4)(B) or § 283; an order under § 271(e)(4)(A) that the effective date of any approval of ANDA No. 220230 be no earlier than the expiration of the '404 patent, including any extension or exclusivity; damages or other relief under § 271(e)(4)(C) for any commercial activity before expiration, with prejudgment interest; a finding that the case is exceptional with attorneys' fees under §§ 271(e)(4) and 285; costs and expenses; and other relief.

Docket activity

Through November 4, 2026, the docket shows the complaint, three corporate disclosure statements, a case assignment entry on November 2, and on November 3 the patent and trademark form (AO 120), summons issued, and a notice of judicial preferences.

What to watch next

Watch for service on the Dr. Reddy's companies, their answer, counterclaims, or a Rule 12 motion, and any motion to consolidate this case with No. 2:25-cv-03967.