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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 bupivacaine hydrochloride freedom to operate?
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. Eleven 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:	11
Bulk Api Vendors:	72
Clinical Trials:	826
Patent Applications:	796
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

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Glossary

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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	018053-002	Approved Prior to Jan 1, 1982	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	071810-001	Dec 11, 1987	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-004	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070584-001	Feb 17, 1986	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration