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Bupivacaine - Generic Drug Details

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

Bupivacaine is the generic ingredient in twelve branded drugs marketed by Pacira Pharms Inc, Aurobindo Pharma Ltd, Hospira, Mylan Asi, Novocol Healthcare, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-one NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has nineteen patent family members in nine countries.

There are twelve drug master file entries for bupivacaine. One supplier is listed for this compound.

Summary for bupivacaine

International Patents:	19
US Patents:	1
Tradenames:	12
Applicants:	12
NDAs:	41
Drug Master File Entries:	12
Suppliers / Packagers:	1
Bulk Api Vendors:	86
Clinical Trials:	1,155
Patent Applications:	6,434
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for bupivacaine
DailyMed Link:	bupivacaine at DailyMed

See drug prices for bupivacaine

Recent Clinical Trials for bupivacaine

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
National Cancer Institute (NCI)	Phase 2
National Cancer Institute (NCI)	Phase 4

See all bupivacaine clinical trials

Pharmacology for bupivacaine

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for bupivacaine

Anesthetics, Local

Synonyms for bupivacaine

( inverted exclamation markA)-bupivacaine

(.+/-.)-1-Butyl-2',6'-pipecoloxylidide

(.+/-.)-Bupivacaine

(+-)-Bupivacaine

(+/-)-1-butyl-n-(2,6-dimethylphenyl)piperidine-2-carboxamide

(+/-)-Bupivacaine

(1)-1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide

(RS)-bupivacaine

1-butyl-2 inverted exclamation mark ,6 inverted exclamation mark -pipecoloxylidide

1-butyl-2-(2,6-xylycarbamoyl)piperidine

1-Butyl-2',6'-pipecoloxylidide

1-butyl-n-(2,6-dimethylphenyl)-2-piperidinecarboxamid

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

1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboximidic acid

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

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

14252-80-3 (HCl)

18010-40-7 (HCl)

180B929

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

2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, (.+/-.)-

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

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

2180-92-9

38396-39-3

4CH-013994

73360-54-0 (HCl.H2O)

AB00053674

AB00053674_10

AB00053674_11

AB00053674-08

AB00053674-09

AC-2096

AC1L1DRE

AC1Q5LX4

AH 250

AK-90074

AKOS001637202

AKOS016842516

AN-14284

Anekain

ANW-45984

API0007792

AX8041457

BCP12242

BCP21825

BDBM50350790

Bloqueina

BPBio1_000298

BRD-A01636364-003-05-2

BRD-A01636364-003-08-6

BS-5224

BSPBio_000270

BSPBio_002607

Bucaine (TN)

Bupivacaina

Bupivacaina [INN-Spanish]

Bupivacaine (USAN/INN)

Bupivacaine [INN:BAN]

Bupivacaine [USAN:INN:BAN]

bupivacaine base

Bupivacaine Carbonate

Bupivacaine HCL KIT

Bupivacaine liposome injectable suspension

Bupivacaine Monohydrochloride, Monohydrate

Bupivacaine,hydrochloride

Bupivacainum

Bupivacainum [INN-Latin]

Bupivan

C07529

C18H28N2O

Carbostesin

cBupivacaine

CHEBI:3215

CHEBI:77431

CHEMBL1098

CS-W023182

CTK8B4736

D07552

DB00297

DepoBupivacaine

DivK1c_000758

dl-1-Butyl-2,6-pipecoloxylidide

dl-1-Butyl-2',6'-pipecoloxylidide

DL-Bupivacaine

DTXSID2022703

DUR-843

EINECS 218-553-3

EINECS 253-911-2

Epitope ID:122662

Exparel

Exparel (TN)

FT-0623286

FT-0699781

GTPL2397

HMS2090F12

HMS3428P06

HSDB 7790

IDI1_000758

J10217

KB-218680

KBio1_000758

KBio2_002004

KBio2_004572

KBio2_007140

KBio3_001827

KBioGR_001516

KBioSS_002004

KS-00000ZRC

L000695

LAC-43

LAC-43 (Salt/Mix)

LEBVLXFERQHONN-UHFFFAOYSA-N

Levobupivacaine free base

LS-109841

LS-2222

M-9606

Marcaina

Marcaine

Marcaine HCL

Marcaine hydrochloride (Salt/Mix)

Marcaine Spinal

Marcaine spinal (Salt/Mix)

MCULE-2286784276

MFCD00941462

MolPort-004-955-820

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

NCGC00178579-01

NCGC00178579-02

NINDS_000758

Prestwick0_000305

Prestwick1_000305

Prestwick2_000305

Prestwick3_000305

Q-100271

R962

racemic bupivacaine

SBI-0051846.P002

SC-26838

SCHEMBL25438

Sensorcaine

Sensorcaine-MPF

Sensorcaine-MPF Spinal

SKY 0402

SKY-0402

SKY0402

SPBio_001558

SPBio_002489

Spectrum_001524

Spectrum2_001589

Spectrum3_000974

Spectrum4_001098

Spectrum5_001483

ST065773

ST2415271

STL484283

TC-134729

Transdur-Bupivacaine

Win 11318

US Patents and Regulatory Information for bupivacaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Asi	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-003	Oct 18, 2011		DISCN	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070554-001	May 21, 1986	AP	RX	No	No
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071171-001	Jun 16, 1988		DISCN	No	No
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-013	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	018304-004	Sep 2, 1983	AP	RX	No	No

Expired US Patents for bupivacaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011

International Patents for bupivacaine

Country	Patent Number	Estimated Expiration
Australia	2006200044
New Zealand	504188
Austria	554748
Canada	2309548
Israel	193778
European Patent Office	1030652