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Bupivacaine hydrochloride - Generic Drug Details

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What are the generic sources for bupivacaine hydrochloride and what is the scope of bupivacaine hydrochloride patent protection?

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

There are eleven drug master file entries for bupivacaine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for bupivacaine hydrochloride

US Patents:	0
Tradenames:	12
Applicants:	8
NDAs:	37
Drug Master File Entries:	11
Suppliers / Packagers:	14
Bulk Api Vendors:	74
Clinical Trials:	826
Patent Applications:	802
Formulation / Manufacturing:	see details
DailyMed Link:	bupivacaine hydrochloride at DailyMed

Pharmacology for bupivacaine hydrochloride

Ingredient-type	Amides Catecholamines
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 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

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

AK161936

AK481431

AKOS015889322

AN-14283

AN-18756

AOB6341

API0001784

AX8018312

B3925

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

HE305322

HMS1568N12

HMS1922I12

HY-B0405A

I01-1868

J-011502

K-4565

KB-48484

KS-00000M4Q

KS-00000XIC

LAC 43

LAC-43

LS-185059

LS-2113

Marcain

Marcain;Marcaine;Sensorcaine;Vivacaine

Marcaine hydrochloride preservation free

MCULE-5414144502

MFCD00078956

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

SIEYLFHKZGLBNX-UHFFFAOYSA-N

SKY 0302

SMR000058218

SPECTRUM1503818

SR-05000001874

SR-05000001874-3

ST013772

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
Amphastar Pharms Inc	DUOCAINE	bupivacaine hydrochloride; lidocaine hydrochloride	INJECTABLE;INJECTION	021496-001	May 23, 2003		DISCN	No	No
Intl Medicated	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	076012-003	Jan 9, 2002		DISCN	No	No
Mylan Asi	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-002	Oct 18, 2011	AP	RX	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070966-001	Oct 13, 1987	AP	RX	No	No
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-007	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes