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BREVIBLOC Drug Profile

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When do Brevibloc patents expire, and what generic alternatives are available?

Brevibloc is a drug marketed by Baxter Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in BREVIBLOC is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for BREVIBLOC

US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	5
Bulk Api Vendors:	60
Clinical Trials:	12
Patent Applications:	560
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BREVIBLOC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREVIBLOC
DailyMed Link:	BREVIBLOC at DailyMed

Pharmacology for BREVIBLOC

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Synonyms for BREVIBLOC

(+-)-Methyl p-(2-hydroxy-3-(isopropylamino)propoxy)hydrocinnamate hydrochloride

(+/-)-methyl p-[2-hydroxy-3-(isopropylamino) propoxy]hydrocinnamate hydrochloride

4-(2-Hydroxy-3-((1-methylethyl)amino)propoxy)benzenepropanoic acid methyl ester HCl

4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benxzenepropanoic Acid Methyl Ester Hydrochloride

4-[2-HYDROXY-3-[(1-METHYLETHYL)AMINO]PROPOXY]BENZENEPROPANOIC ACID METHYL ESTER HYDROCHLORIDE

4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benzenepropanoic acid methyl ester hydrochloride hydrochloride

598E034

81147-92-4 (Parent)

81161-17-3

81161-17-3, 81147-92-4(free base)

AB0013228

AB07716

AC-6972

AC1L2XGQ

AC1Q3EA6

AKOS015895316

AN-9460

API0001758

Asl 8052

ASL-8052

Benzenepropanoic acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, methyl ester, hydrochloride

Benzenepropanoic acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, methyl ester, hydrochloride, (+-)-

Benzenepropanoic acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, methyl ester,hydrochloride

BG0502

Brevibloc (TN)

Brevibloc Double Strength in plastic container

Brevibloc in plastic container

C16H25NO4.HCl

CAS-81161-17-3

CCG-100972

CCG-220890

CHEBI:4857

CHEMBL1201115

CPD000469141

CS-4908

CTK8F9497

D00644

DSSTox_CID_28929

DSSTox_GSID_49003

DSSTox_RID_83195

DTXSID7049003

EBD13377

Esmolol (hydrochloride)

Esmolol HCL

Esmolol hydrochloride

Esmolol hydrochloride (JAN/USAN)

Esmolol hydrochloride [USAN]

Esmolol hydrochloride, >=98% (HPLC), solid

Esmolol hydrochloride, United States Pharmacopeia (USP) Reference Standard

Esmolol(hydrochloride)

Esmololhydrochloride

FT-0082446

FT-0601541

H746

HSDB 6530

HY-B1392

I06-0682

J-003862

KS-00001FBX

KS-1353

LS-31122

methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)propanoate hydrochloride

METHYL 3-(4-[2-HYDROXY-3-(ISOPROPYLAMINO)PROPOXY]PHENYL)PROPANOATE HYDROCHLORIDE

methyl 3-(4-{2-hydroxy-3-[(methylethyl)amino]propoxy}phenyl)propanoate, chlori de

METHYL 3-[4-(2-HYDROXY-3-PROPAN-2-YLAMINO-PROPOXY)PHENYL]PROPANOATE HYDROCHLORIDE

Methyl 3-[4-(2-hydroxy-3-propan-2-ylamino-propoxy)phenyl]propanoate hydrochloride; Brevibloc

methyl 3-[4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl]propanoate hydrochloride

methyl 3-[4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]propanoate hydrochloride

Methyl 3-{4-[2-Hydroxy-3-(isopropylamino)propoxy]phenyl}propanoate hydrochloride (Esmolol HCl)

MLS001401393

MolPort-003-847-093

NC00222

NCGC00185766-01

NCGC00185766-04

OR161498

Q-201070

s4100

SAM001246533

SBB055181

SCHEMBL41086

SMR000469141

TL8005428

Tox21_113496

Tox21_113496_1

W-1240

US Patents and Regulatory Information for BREVIBLOC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988		DISCN	No	No
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003		RX	Yes	Yes					Y
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003		DISCN	No	No					Y
Baxter Hlthcare	BREVIBLOC IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-004	Feb 16, 2001		RX	Yes	Yes					Y
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-006	Feb 25, 2003	AP	RX	Yes	Yes					Y
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-006	Feb 25, 2003	AP	RX	Yes	Yes					Y
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003		RX	Yes	Yes					Y

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Expired US Patents for BREVIBLOC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-006	Feb 25, 2003
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-007	May 28, 2003

Paragraph IV (Patent) Challenges for BREVIBLOC

Drugname	Dosage	Strength	RLD	Date
	Injection	10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags

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International Patents for BREVIBLOC

Country	Document Number	Estimated Expiration
Poland	216192
China	1981739
Portugal	1368019
Denmark	1368019
Argentina	098013
Israel	151359
Czech Republic	304290