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NDA

REMIMAZOLAM BESYLATE | N212295 | ACACIA PHARMA LTD

1 strength11 unique patents0 unique exclusivities

Patent Timeline

11 unique patents by expiration date

Active (11)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Apr. 30, 2033

Nov. 7, 2031

Jul. 10, 2027

Jan. 13, 2034

Jul. 10, 2027

Nov. 7, 2031

Nov. 7, 2031

Nov. 7, 2031

Jul. 10, 2027

Nov. 7, 2031

Jul. 10, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Acacia Pharma Limited et al v. Galenicum Health S.L.U. 1:2025cv00010 2 patentsANDA 219794remimazolam	D. Del.	2025-01-03	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults NCT06333145	Phase 4	Completed	Tongji Hospital	165	2024-02-04 → 2026-06-20
RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery NCT05606315	Phase 4	Terminated	Nanfang Hospital, Southern Medical University	117	2022-03-16 → 2025-02-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

PAION UK LTDREMIMAZOLAM

DMF 327482019

MOEHS IBERICA SLREMIMAZOLAM BESYLATE

DMF 363322021

TEVA PHARMACEUTICAL INDUSTRIES LTDREMIMAZOLAM BESYLATE

DMF 398132024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 9, 2021	SUPPL -2	View Letter (PDF)
Dec 1, 2020	SUPPL -1	View Letter (PDF)
Jul 6, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE/VIAL

RLD

11 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Oct 6, 2020

Patents (11)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9561236	Apr 30, 2033	—	—	—		—
9737547	Nov 7, 2031	—	—	—		—
9777007	Jul 10, 2027	—	—	Yes	—	—
9827251	Jan 13, 2034	—	—	—		—
9914738	Jul 10, 2027	—	—	Yes	—	—
10052334	Nov 7, 2031	—	—	—		—
10195210	Nov 7, 2031	—	—	—		—
10342800	Nov 7, 2031	—	—	—		—
10472365	Jul 10, 2027	—	—	—		—
10722522	Nov 7, 2031	—	—	—		—
10961250	Jul 10, 2027	—	—	Yes		—