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BREVIBLOC

NDA

ESMOLOL HYDROCHLORIDE | N019386 | BAXTER HEALTHCARE CORP

5 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Processed EEG Monitoring During Controlled Hypotension in Patients Undergoing Rhinoplasty NCT07671781	—	Completed	Gazi University	64	2025-11-01 → 2026-02-25

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

Medicare Part B Spending

CMS physician-administered drug spending for Brevibloc (2023)

Total Spending

$37.37

Total Claims

Beneficiaries

ASP Price

—

HCPCS: J1805 — Injection, esmolol hydrochloride, 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain5 active DMFs1 inactive

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

DELMAR CHEMICALS INCESMOLOL HYDROCHLORIDE

DMF 44751982

FINORGA SASESMOLOL HYDROCHLORIDE

DMF 68681987

TARO PHARMACEUTICAL INDUSTRIES LTDESMOLOL HYDROCHLORIDE

DMF 168632003

MSN LABORATORIES PRIVATE LTDESMOLOL HYDROCHLORIDE USP [ROUTE CODE-"EH"]

DMF 260242012

GLOBAL CALCIUM PRIVATE LTDESMOLOL HYDROCHLORIDE USP

DMF 368772023

GANES CHEMICALS INC PENNSVILLE DIVInactiveESMOLOL HYDROCHLORIDE

DMF 51261983

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2025	SUPPL -55	View Letter (PDF)
Jun 16, 2023	SUPPL -53	View Letter (PDF)
Dec 13, 2012	SUPPL -43	View Letter (PDF)
Nov 8, 2007	SUPPL -39	View Letter (PDF)
Aug 26, 2003	SUPPL -24	View Letter (PDF)
May 30, 2003	SUPPL -22	View Letter (PDF)
Mar 10, 2003	SUPPL -21	View Letter (PDF)
Jan 27, 2003	SUPPL -20	View Letter (PDF)
Jan 27, 2003	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#003 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 15, 1988

No patent or exclusivity listings for this strength.

#006 — 10MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 25, 2003

#007 — 20MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 28, 2003

#005 — 2GM/100ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 27, 2003

#004 — 1GM/100ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 16, 2001