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Last Updated: December 5, 2019

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Labetalol hydrochloride - Generic Drug Details

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What are the generic sources for labetalol hydrochloride and what is the scope of patent protection?

Labetalol hydrochloride is the generic ingredient in three branded drugs marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Mylan Asi, West-ward Pharms Int, Schering, Sebela Ireland Ltd, Athem, Cadila Pharms Ltd, Heritage Pharma, Innogenix, Par Form, Sandoz, Teva, Twi Pharms, Watson Labs, Zydus Pharms, and Cnty Line Pharms, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for labetalol hydrochloride. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for labetalol hydrochloride

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SponsorPhase
Vanderbilt University Medical CenterPhase 2
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2
Albany Medical CollegePhase 4

See all labetalol hydrochloride clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MG/MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for labetalol hydrochloride
Medical Subject Heading (MeSH) Categories for labetalol hydrochloride
Synonyms for labetalol hydrochloride
(R*,R*)-(1)-5-(1-Hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)salicylamide monohydrochloride
1GEV3BAW9J
2-Hydroxy-5-(1-hydroxy-2-((4-phenylbutan-2-yl)amino)ethyl)benzamide HCl
2-Hydroxy-5-(1-hydroxy-2-((4-phenylbutan-2-yl)amino)ethyl)benzamide hydrochloride
2-Hydroxy-5-(1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl)benzamide HCl
2-hydroxy-5-(1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl)benzamide hydrochloride
2-Hydroxy-5-(1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl)benzamide hydrochloride
2-hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide hydrochloride
2-hydroxy-5-[1-hydroxy-2-(4-phenylbutan-2-ylamino)ethyl]benzamide;hydrochloride
2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenyl-propyl)amino]ethyl]benzamide hydrochloride
2-Hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide hydrochloride
32780-64-6
4CH-016313
5-(1-Hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)salicylamide hydrochloride
5-(1-Hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)salicylamide monohydrochloride
5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide hydrochloride
5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide monohydrochloride
72487-34-4
780L646
AC-1389
AC1L2G48
AC1Q5DEI
AH 5158A
AH-5158
AH-5158A
AK144692
AKOS015895575
Amipress
AN-14950
AOB5072
API0003104
AX8135749
BC678573
BCP13886
Benzamide, 2-hydroxy-5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)-, monohydrochloride
Benzamide, 2-hydroxy-5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)-,monohydrochloride
Benzamide, 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-, hydrochloride (1:1)
Benzamide,2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-, hydrochloride(1:1)
Benzamide,monohydrochloride
C-20992
C19H24N2O3.HCl
C19H25ClN2O3
CAS-32780-64-6
CCG-40314
CCRIS 1086
CHEBI:6344
CHEMBL1200323
CPD000058463
CS-4706
CTK4G9285
D00600
DSSTox_CID_24654
DSSTox_GSID_44654
DSSTox_RID_80378
DTXSID0044654
EINECS 251-211-1
EINECS 276-694-6
EU-0100687
FT-0630564
HMS1568H16
HMS1922M13
HY-B1108
I06-0868
Ipolab
J10319
KS-00000GGU
La.beta.lol hydrochloride
Labetalol hydrochloride
Labetalol (hydrochloride)
Labetalol HCL
Labetalol HCl (Mixture of Diastereomers)
Labetalol hydrochloride (JP17/USP)
Labetalol hydrochloride [USAN:JAN]
Labetalol hydrochloride [USAN:USP:JAN]
Labetalol hydrochloride, >98% (TLC), powder
Labetalol hydrochloride, European Pharmacopoeia (EP) Reference Standard
Labetalol Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Labetalol hydrochloride, United States Pharmacopeia (USP) Reference Standard
Labrocol
LP00687
LS-26937
MFCD00057663
MLS000069666
MLS001148626
MLS002222197
MolPort-003-666-813
NC00571
NCGC00016810-01
NCGC00094044-01
NCGC00094044-02
NCGC00094044-03
NCGC00094044-04
NCGC00094044-05
NCGC00256847-01
NCGC00261372-01
Normodyne (TN)
NSC 290312
NSC-290312
NSC-758438
NSC290312
NSC758438
Opera_ID_1625
Pharmakon1600-01503243
Presdate
Pressalolo
Prestwick_290
s4291
Salicylamide, 5-(1-hydroxy-2-((1-methyl-3-phenylpropyl)amino)ethyl)-, hydrochloride
Salicylamide, hydrochloride
SAM002564217
SC-58270
ScH 15719W
Sch-15719W
SCHEMBL41230
SMR000058463
SPECTRUM1503243
SR-01000000209
SR-01000000209-2
SR-01000000209-7
SS-4219
ST2410032
SW196595-3
Tox21_110623
Tox21_302725
Tox21_500687
Trandate (TN)
UNII-1GEV3BAW9J
VA11135
WQVZLXWQESQGIF-UHFFFAOYSA-N

US Patents and Regulatory Information for labetalol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074989-002 Sep 30, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075133-003 Aug 3, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-002 Aug 1, 1984 DISCN Yes No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075303-001 May 28, 1999 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

Expired US Patents for labetalol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-003 Aug 1, 1984   Start Trial   Start Trial
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-001 May 24, 1985   Start Trial   Start Trial
Schering NORMODYNE labetalol hydrochloride INJECTABLE;INJECTION 018686-001 Aug 1, 1984   Start Trial   Start Trial
Sebela Ireland Ltd TRANDATE labetalol hydrochloride INJECTABLE;INJECTION 019425-001 Dec 31, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.