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Bupivacaine - Generic Drug Details

What are the generic drug sources for bupivacaine and what is the scope of bupivacaine patent protection?
Bupivacaine is the generic ingredient in thirteen branded drugs marketed by Pacira Pharms Inc, Aurobindo Pharma Ltd, Hospira, Mylan Asi, Intl Medicated, Fresenius Kabi Usa, Baxter Hlthcare Corp, Septodont, and Amphastar Pharms Inc, and is included in thirty-eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has forty-one patent family members in fifteen countries.

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

Summary for bupivacaine

International Patents:	41
US Patents:	4
Tradenames:	13
Applicants:	9
NDAs:	38
Drug Master File Entries:	11
Suppliers / Packagers:	1
Bulk Api Vendors:	75
Clinical Trials:	826
Patent Applications:	6,326
Formulation / Manufacturing:	see details
DailyMed Link:	bupivacaine at DailyMed

Pharmacology for bupivacaine

Ingredient-type	Amides
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
(+/-)-Bupivacaine
(1)-1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide
(inverted exclamation markA)-bupivacaine
(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)-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
BDBM50350790
Bio-0886
Bloqueina
BPBio1_000298
BRD-A01636364-003-05-2
BRD-A01636364-003-08-6
BS-5224
BSPBio_000270
BSPBio_002607
bucain
Bucaine
Bucaine (TN)
Bupivacaina
Bupivacaina [INN-Spanish]
Bupivacaine (INN)
Bupivacaine (USAN/INN)
Bupivacaine [INN:BAN]
Bupivacaine [USAN:INN:BAN]
bupivacaine base
Bupivacaine Carbonate
Bupivacaine HCL KIT
Bupivacaine hydrochloride anhydrous
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
D0A0FL
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
HE058460
HE301859
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
LP075507
LS-109841
LS-2222
M-9606
Marcain (TN)
Marcaina
Marcaine
Marcaine (TN)
Marcaine HCL
Marcaine hydrochloride (Salt/Mix)
Marcaine Spinal
Marcaine spinal (Salt/Mix)
MCULE-2286784276
MFCD00243007
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 (TN)
Sensorcaine-MPF
Sensorcaine-MPF Spinal
Sensorcaine-MPFSpinal
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
Vivacaine (TN)
Win 11318
Win 11318 HCl

US Patents and Regulatory Information for bupivacaine

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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
Amphastar Pharms Inc	DUOCAINE	bupivacaine hydrochloride; lidocaine hydrochloride	INJECTABLE;INJECTION	021496-001	May 23, 2003		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Mylan Asi	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-003	Oct 18, 2011	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070552-001	May 21, 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

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Expired US Patents for bupivacaine

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

Non-Orange Book US Patents for bupivacaine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
6,045,824	Sustained-release liposomal anesthetic compositions	➤ Sign Up
9,192,575	Sustained-release liposomal anesthetic compositions	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration