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Last Updated: March 29, 2020

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Acebutolol hydrochloride - Generic Drug Details

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

Acebutolol hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharm, Ani Pharms Inc, Mylan, and Promius Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for acebutolol hydrochloride.

Summary for acebutolol hydrochloride
Recent Clinical Trials for acebutolol hydrochloride

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

SponsorPhase
University Hospital, MontpellierPhase 3
Oita UniversityPhase 4
Seoul National University HospitalPhase 4

See all acebutolol hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for acebutolol hydrochloride
Synonyms for acebutolol hydrochloride
(+-)-3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)butyranilide monohydrochloride
(1)-N-(3-Acetyl-4-(2-hydroxy-3-((isopropyl)amino)propoxy)phenyl)butyramide monohydrochloride
3'-Acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)butyranilide hydrochloride
34381-68-5
381A685
4CH-016371
A822205
AB03018
AC-002
Acebutolol (hydrochloride)
Acebutolol HCL
Acebutolol hydrochloride (JP17/USP)
Acebutolol hydrochloride [USP:JAN]
Acebutolol Hydrochloride 1.0 mg/ml in Methanol (as free base)
Acebutolol hydrochloride, analytical standard
Acebutolol hydrochloride, European Pharmacopoeia (EP) Reference Standard
Acebutolol hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Acebutolol hydrochloride, United States Pharmacopeia (USP) Reference Standard
acebutolol-hcl
AK116443
AKOS015895193
API0001353
AX8112021
BCP28416
BG0005
Butanamide, N-(3-acetyl-4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)phenyl)-, monohydrochloride, (+-)-
Butyranilide, 3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)-, monohydrochloride, (+-)-
C-21196
C07677
C18H29ClN2O4
CAS-34381-68-5
CC-23635
CCG-39278
CCRIS 1102
CHEBI:2380
CHEMBL1200813
CPD000058800
CS-2637
CTK8F7495
D00597
DB-048610
Diasectral
dl-1-(2-Acetyl-4-butyramidophenoxy)-2-hydroxy-3-isopropylaminopropane hydrochloride
DSSTox_CID_25461
DSSTox_GSID_45461
DSSTox_RID_80892
DTXSID5045461
EINECS 251-980-3
FT-0630582
HMS1568M19
HMS1921A06
HSDB 6524
HY-17497A
IL 17803A
IL-17803A
J-019577
J10323
KS-00000FKS
KS-5245
M&B 17,803A
M&B 17803A
M&B-17803A
MCULE-8284913115
MLS000069553
MLS001076107
MLS002222219
MLS002548874
N-(3-Acetyl-4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)butyramide hydrochloride
N-(3-acetyl-4-{2-hydroxy-3-[(methylethyl)amino]propoxy}phenyl)butanamide, chlo ride
N-[3-acetyl-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]butanamide hydrochloride
N-[3-acetyl-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]butanamide;hydrochloride
N-[3-ethanoyl-4-[2-oxidanyl-3-(propan-2-ylamino)propoxy]phenyl]butanamide hydrochloride
N-{3-acetyl-4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl}butanamide hydrochloride
NC00669
NCGC00016827-01
NCGC00018215-06
NCGC00094830-01
NCGC00094830-02
NCGC00094830-03
NCGC00094830-04
NSC-757412
NSC757412
Opera_ID_1259
Pharmakon1600-01500665
Prent
Prestwick_512
Q27105651
R896
s4010
SAM002264591
SCHEMBL41004
Sectral
Sectral (TN)
SMR000058800
SPECTRUM1500665
SR-01000000133
SR-01000000133-3
ST51014891
SW196705-3
Tox21_110633
Tox21_110633_1
Wesfalin

US Patents and Regulatory Information for acebutolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharm ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 075047-001 Dec 30, 1999 AB RX No Yes   Start Trial   Start Trial   Start Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-003 Dec 28, 1984 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 074288-002 Apr 24, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 074007-002 Oct 18, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharm ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 075047-002 Dec 30, 1999 AB RX No Yes   Start Trial   Start Trial   Start Trial
Mylan ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 074288-001 Apr 24, 1995 AB 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 acebutolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-001 Dec 28, 1984   Start Trial   Start Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-001 Dec 28, 1984   Start Trial   Start Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-003 Dec 28, 1984   Start Trial   Start Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-003 Dec 28, 1984   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
AstraZeneca
Mallinckrodt
Moodys
McKinsey

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