Chiesi Sues Zydus Over Proposed Generic CLEVIPREX (Clevidipine).

Chiesi USA, Inc. and Chiesi Farmaceutici S.p.A. v. Zydus Lifesciences Global FZE and Zydus Pharmaceuticals (USA) Inc., No. 3:26-cv-14339 (D.N.J.), is a Hatch-Waxman patent complaint filed November 4, 2026. Chiesi USA, Inc. is a Delaware corporation with its principal place of business in Cary, North Carolina, is a wholly owned subsidiary of Chiesi Farmaceutici S.p.A., and holds NDA No. 022156 for CLEVIPREX (clevidipine) injectable emulsion, which the complaint says is approved in 25 mg/50 mL and 50 mg/100 mL presentations and is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Chiesi Farmaceutici S.p.A. is an Italian corporation based in Parma, Italy, and is the owner and assignee of the patents in suit.

The complaint alleges, on information and belief, that Zydus Lifesciences Global FZE is a United Arab Emirates company based in Dubai, that Zydus Pharmaceuticals (USA) Inc. is a New Jersey corporation based in Pennington, New Jersey, and that Zydus USA acts as Zydus FZE's U.S. agent for the ANDA and transmitted the notice letter. It pleads venue under 28 U.S.C. § 1400(b) as to Zydus USA and 28 U.S.C. § 1391(c)(3) as to Zydus FZE.

The patents and ANDA

The complaint asserts three Orange Book patents for CLEVIPREX, each titled Clevidipine Emulsion Formulations Containing Antimicrobial Agents: U.S. Patent 8,658,676, issued February 25, 2014; U.S. Patent 10,010,537, issued July 3, 2018; and U.S. Patent 11,103,490, issued August 31, 2021. The complaint says each is listed in the Orange Book for CLEVIPREX and that the Orange Book lists October 10, 2031, as the expiration date for each. Claim 1 of the '676 patent covers a pharmaceutical formulation of an effective amount of clevidipine, or a pharmaceutically acceptable salt or ester, with EDTA as an antimicrobial agent at about 0.001 to about 1.5% w/v, a lipid, an emulsifier, a tonicity modifier, and water, wherein the formulation is resistant to microbial growth. Claim 1 of the '537 patent covers a formulation of clevidipine butyrate at about 0.01 to about 1% w/v, EDTA at about 0.001 to about 0.1% w/v, soybean oil at about 4 to about 30% w/v, purified egg yolk phospholipids at about 0.2 to about 2% w/v, glycerin at about 2 to about 3% w/v, and water up to 100%. Claim 1 of the '490 patent covers a formulation of an effective amount of clevidipine, or a pharmaceutically acceptable salt or ester, at about 0.005 to about 1% w/v; EDTA or a salt thereof as a chelating antimicrobial agent at about 0.001 to about 1.5% w/v; a lipid at about 2 to about 30% w/v; an emulsifier at about 0.2 to about 2.0% w/v; a tonicity modifier at about 2 to about 3% w/v; oleic acid as a co-emulsifier at about 0.01 to about 2% w/v; water; and an antioxidant from a listed group, with a pH of about 6.0 to about 8.0 and a negative zeta potential.

The complaint alleges, on information and belief, that Zydus submitted ANDA No. 219831 seeking approval of clevidipine injectable emulsion, 25 mg/50 mL (0.5 mg/mL) and 50 mg/100 mL (0.5 mg/mL), and that the ANDA identifies CLEVIPREX as the reference listed drug. It says that by letter dated September 22, 2026, Zydus FZE, through Zydus USA, notified Chiesi that the ANDA contains Paragraph IV certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) as to all three patents, that Chiesi received the letter on or about September 22, 2026, and that the letter states FDA designated the application ANDA No. 219831 and that Zydus received FDA's Paragraph IV acknowledgment letter on September 18, 2026. The complaint says the suit was filed within 45 days of Chiesi's receipt of the letter.

The counts

Count I alleges that the ANDA submission infringes the '676 patent under 35 U.S.C. § 271(e)(2)(A), and alleges, on information and belief, that upon FDA approval Zydus will directly infringe under § 271(a), induce infringement under § 271(b), and contributorily infringe under § 271(c). Counts II and III plead the same theories for the '537 and '490 patents. The complaint also alleges, on information and belief, that Zydus's ANDA product meets each limitation of at least one claim of each patent, literally or under the doctrine of equivalents.

The prayer asks for judgments of infringement under § 271(e)(2)(A) and under § 271(a), (b), and/or (c); an order under § 271(e)(4)(A) that any FDA approval of ANDA No. 219831 be effective no earlier than the latest patent expiration including extensions and exclusivity; preliminary and permanent injunctions under §§ 271(e)(4)(B) and 283; damages if Zydus launches early, including enhanced damages for willful infringement; a judgment that the patents are valid and enforceable; exceptional-case fees under § 285; and costs.

Docket

Through November 5, 2026, the docket shows the complaint and a corporate disclosure statement on November 4, and the patent and trademark form (AO 120) and summons issued on November 5. The complaint's Local Rule 11.2 and 40.1 certification identifies a related action, No. 3:19-cv-18756 (D.N.J.), closed August 30, 2022, which involved the same reference listed drug and two of the same patents.

What to watch next

Watch for service on the Zydus companies, their answer, counterclaims, or a Rule 12 motion, and a scheduling order. The case can end at any time, including by settlement or voluntary dismissal.