Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

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.

Recent Clinical Trials for bupivacaine hydrochloride

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

SponsorPhase
Johns Hopkins UniversityEarly Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 3
Saddam Al DemourN/A

See all bupivacaine hydrochloride clinical trials

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   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE KIT bupivacaine hydrochloride INJECTABLE;INJECTION 019978-001 Sep 3, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE KIT bupivacaine hydrochloride INJECTABLE;INJECTION 019978-002 Sep 3, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 018304-001 Approved Prior to Jan 1, 1982 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022046-001 Jul 13, 1983 DISCN Yes No   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 018053-003 Approved Prior to Jan 1, 1982 AP RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Medtronic
Mallinckrodt
Express Scripts
Baxter

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