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Last Updated: October 20, 2019

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Benazepril hydrochloride - Generic Drug Details

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What are the generic drug sources for benazepril hydrochloride and what is the scope of freedom to operate?

Benazepril hydrochloride is the generic ingredient in four branded drugs marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma, Casi Pharms Inc, Genpharm, Heritage Pharma, Mylan, Prinston Inc, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Us Pharms Holdings I, Mylan Pharms Inc, and Sandoz, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for benazepril hydrochloride. Thirty-two suppliers are listed for this compound.

Recent Clinical Trials for benazepril hydrochloride

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

SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 4
Sun Yat-sen UniversityPhase 2/Phase 3
University of NebraskaPhase 4

See all benazepril hydrochloride clinical trials

Pharmacology for benazepril hydrochloride
Synonyms for benazepril hydrochloride
(3S)-3-(((1S)-1-Carboxy-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, 3-ethyl ester, monohydrochloride
(3S)-3-[(1S)-1-Ethoxycarbonyl-3-phenylpropyl]amino-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic Acid Hydrochloride
(3S)-3-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid hydrochloride
[(3S)-3-{[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-1-benzazepin-1-yl]acetic acid hydrochloride
1H-1-Benzazepine-1-acetic acid, 2,3,4,5-tetrahydro-3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2-oxo-, monohydrochloride, (S-(R*,R*))-
1H-1-Benzazepine-1-acetic acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, monohydrochloride, (S-(R*,R*))-
1H-1-benzazepine-1-acetic acid,3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-,monohydrochloride,(S-(R*,R*))-
1H-1-Benzazepine-1-acetic acid,3-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-,hydrochloride,(3S)
2-((S)-3-(((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)amino)-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetic acid hydrochloride
2-((S)-3-((S)-1-ethoxy-1-oxo-4-phenylbutan-2-ylamino)-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetic acid hydrochloride
2-[(3S)-3-[[(1S)-1-ethoxycarbonyl-3-phenyl-propyl]amino]-2-oxo-4,5-dihydro-3H-1-benzazepin-1-yl]acetic acid hydrochloride
2-[(3S)-3-[[(2S)-1-ethoxy-1-oxidanylidene-4-phenyl-butan-2-yl]amino]-2-oxidanylidene-4,5-dihydro-3H-1-benzazepin-1-yl]ethanoic acid hydrochloride
2-[(3S)-3-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]-2-oxo-4,5-dihydro-3H-1-benzazepin-1-yl]acetic acid hydrochloride
2-[(3S)-3-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]-2-oxo-4,5-dihydro-3H-1-benzazepin-1-yl]acetic acid;hydrochloride
86541-74-4
A841712
AC1NSFPI
AK163656
AKOS015888536
AN-14751
ANW-42214
AX8022900
B3611
BCP9000387
BCPP000350
benazcpril
Benazepril (hydrochloride)
Benazepril for system suitability, European Pharmacopoeia (EP) Reference Standard
Benazepril HCl
Benazepril hydrochloride (JAN/USAN)
Benazepril hydrochloride [USAN:JAN]
Benazepril hydrochloride [USAN:USP:JAN]
Benazepril hydrochloride, >=98% (HPLC), solid
Benazepril hydrochloride, European Pharmacopoeia (EP) Reference Standard
Benazepril hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Benazepril hydrochloride, United States Pharmacopeia (USP) Reference Standard
Benazepril hydrochloride, VETRANAL(TM), analytical standard
Benazepril Hydrochloride,(S)
benazepril monohydrochloride
Briem
C07701
C24H28N2O5.HCl
C24H29ClN2O5
CAS-86541-74-4
CCG-39520
CGS 14824A
CGS 14824A HCl
CGS-14824A
CGS-14824A HCL
CHEBI:3012
CHEMBL1694
Cibace
Cibacen
Cibacen CHF
Cibacene
CPD000469199
CS-1796
CTK8B3291
D00620
DSSTox_CID_25922
DSSTox_GSID_45922
DSSTox_RID_81225
DTXSID9045922
FT-0654634
HMS1922L07
HSDB 7081
HY-B0093A
KB-65121
KS-00000XHP
KS-1397
Labopol
Lotensin
Lotensin (TN)
LS-27972
MFCD00895734
MLS001076668
MLS001333171
MLS001333172
MLS001401429
MolPort-003-666-601
N1SN99T69T
NC00211
NCGC00095132-01
NCGC00165740-05
NSC-758920
NSC758920
Pharmakon1600-01505200
s1284
SAM001246712
SC-22757
SCHEMBL42194
SMR000469199
SPECTRUM1505200
SR-01000762893
SR-01000762893-3
SW197591-3
Tensanil
TL8005618
Tox21_111441
Tox21_111441_1
TR-026954
TWT-8154
UNII-N1SN99T69T
VPSRQEHTHIMDQM-FKLPMGAJSA-N
Zinadril

US Patents and Regulatory Information for benazepril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 078212-003 May 22, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-003 Jun 25, 1991 AB RX Yes No   Start Trial   Start Trial   Start Trial
Teva BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 076211-001 Feb 11, 2004 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 benazepril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-001 Jun 25, 1991   Start Trial   Start Trial
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-003 Jun 25, 1991   Start Trial   Start Trial
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-004 Jun 25, 1991   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:

McKesson
Harvard Business School
Mallinckrodt
Boehringer Ingelheim
Baxter
Express Scripts

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