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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 patent protection?
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.
Summary for BUPIVACAINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 11 |
Applicants: | 10 |
NDAs: | 39 |
Drug Master File Entries: | 12 |
Suppliers / Packagers: | 15 |
Bulk Api Vendors: | 83 |
Clinical Trials: | 1,120 |
Patent Applications: | 891 |
Formulation / Manufacturing: | see details |
DailyMed Link: | BUPIVACAINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for BUPIVACAINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Early Phase 1 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 3 |
Saddam Al Demour | N/A |
Pharmacology for BUPIVACAINE HYDROCHLORIDE
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Asi | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091487-002 | Oct 18, 2011 | 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 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 016964-010 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Hospira | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 018053-002 | Approved Prior to Jan 1, 1982 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Fresenius Kabi Usa | SENSORCAINE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070552-001 | May 21, 1986 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Fresenius Kabi Usa | SENSORCAINE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 070967-001 | Oct 13, 1987 | 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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