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Bupivacaine hydrochloride - Generic Drug Details

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What are the generic drug sources for bupivacaine hydrochloride and what is the scope of freedom to operate?

Bupivacaine hydrochloride is the generic ingredient in eleven branded drugs marketed by Aurobindo Pharma Ltd, Hospira, Mylan Asi, Novocol Healthcare, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Septodont, and Amphastar Pharms Inc, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for bupivacaine hydrochloride. Fifteen suppliers are listed for this compound.

Summary for bupivacaine hydrochloride

US Patents:	0
Tradenames:	11
Applicants:	10
NDAs:	39
Drug Master File Entries:	12
Suppliers / Packagers:	15
Bulk Api Vendors:	86
Clinical Trials:	1,120
Patent Applications:	891
Formulation / Manufacturing:	see details
DailyMed Link:	bupivacaine hydrochloride at DailyMed

Recent Clinical Trials for bupivacaine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	Early Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 3
Saddam Al Demour	N/A

See all bupivacaine hydrochloride clinical trials

Pharmacology for bupivacaine hydrochloride

Drug Class	Amide Local Anesthetic alpha-Adrenergic Agonist beta-Adrenergic Agonist Catecholamine
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Synonyms for bupivacaine hydrochloride

(+-)-1-Butyl-2',6'-pipecoloxylidide monohydrochloride, monohydrate

(+-)-Bupivacaine hydrochloride

1-butyl-2-[(2,6-dimethylphenyl)carbamoyl]piperidinium chloride

1-butyl-2-piperidylformo-2',6'-xylidide hydrochloride

1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide

1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide hydrochloride dl-1-n-Butylpiperidine-2-carboxylic acid 2,6-dimethylanilide hydrochloride

1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide monohydrochloride

1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide hydrochloride

1-Butyl-N-[2,6-dimethylphenyl]-2-piperidinecarboxamide

14252-80-3

14252-80-3 (HCl)

15233-43-9

18010-40-7

2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochlorde, monohydrate

2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride

2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate

2-Piperidinecarboxamide,6-dimethylphenyl)-, hydrochloride

2',6'-Pipecoloxylidide, 1-butyl-, hydrochloride

2',6'-Pipecoloxylidide, 1-butyl-, monohydrochloride

52B803

73360-54-0 (HCl.H2O)

AB2000569

AC1L21TT

ACT04725

AH 2250

AH-2250

AK481431

AKOS015889322

AN-14283

AN-18756

AOB6341

API0001784

AX8018312

B3925

BCP22697

BCP22708

BCP9000461

Bicain

Bupicacain hydrochlorid-1-wasser

bupivacain hydrochloride

Bupivacaine (hydrochloride)

Bupivacaine HCL

bupivacaine hydrochloride (anhydrous)

Bupivacaine hydrochloride (Marcain)

Bupivacaine hydrochloride [JAN]

Bupivacaine hydrochloride [USAN]

Bupivacaine hydrochloride anhydrous

Bupivacaine hydrochloride kit

Bupivacaine hydrochloride preservation free

bupivacaine monohydrochloride

CCG-39367

CHEBI:31322

CHEBI:77441

CHEMBL1200396

CS-2505

CTK8F8361

DTXSID0030877

EINECS 241-917-8

FD-0235

FT-0082605

FT-0607564

FT-0623287

H875

HMS1568N12

HMS1922I12

HY-B0405A

I01-1868

J-011502

K-4565

KB-48484

KS-00000M4Q

KS-00000XIC

LAC 43

LAC-43

levobupivacaine hydrochloride (anhydrous)

LS-185059

LS-2113

Marcain

Marcain;Marcaine;Sensorcaine;Vivacaine

Marcaine hydrochloride preservation free

Marcaine Spinal

MCULE-5414144502

MLS001361336

MLS002154259

MNarcaine hydrochloride

MolPort-003-666-503

N-(2,6-dimethylphenyl)(1-butyl(2-piperidyl))carboxamide, chloride

NCGC00095072-01

NCGC00095072-02

NSC-119660

NSC-758631

NSC119660

NSC758631

Pharmakon1600-01503818

Prestwick_894

Q-100158

rac-1-butyl-2-[(2,6-dimethylphenyl)carbamoyl]piperidinium chloride

rac-1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide hydrochloride

s2454

SC-24334

SC-94629

SCHEMBL34374

Sensorcaine

SIEYLFHKZGLBNX-UHFFFAOYSA-N

SKY 0302

SMR000058218

SPECTRUM1503818

SR-05000001874

SR-05000001874-3

ST013772

SW197015-3

Vivacaine

Win 11,318

Win 11318 HCl

WIN-11318

US Patents and Regulatory Information for bupivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070587-001	Mar 3, 1987		DISCN	No	No
Hospira	BUPIVACAINE HYDROCHLORIDE KIT	bupivacaine hydrochloride	INJECTABLE;INJECTION	019978-001	Sep 3, 1992		DISCN	No	No
Hospira	BUPIVACAINE HYDROCHLORIDE KIT	bupivacaine hydrochloride	INJECTABLE;INJECTION	019978-002	Sep 3, 1992		DISCN	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	018304-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	022046-001	Jul 13, 1983		DISCN	Yes	No
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	018053-003	Approved Prior to Jan 1, 1982	AP	RX	No	No