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Last Updated: February 17, 2020

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Quinapril hydrochloride - Generic Drug Details

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

Quinapril hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer Pharms, Actavis Elizabeth, Actavis Labs Fl Inc, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan, Prinston Inc, Sun Pharm Inds Ltd, and Yaopharma Co Ltd, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for quinapril hydrochloride. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for quinapril hydrochloride

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

SponsorPhase
University of NebraskaPhase 4
PfizerN/A
British Heart FoundationPhase 3

See all quinapril hydrochloride clinical trials

Recent Litigation for quinapril hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Apotex, Inc. v. Teva Pharmaceutical Industries, Ltd.2013-03-14
Apotex, Inc. v. Mylan Pharmaceuticals, Inc.2012-04-20
Apotex, Inc. v. UCB, Inc.2012-04-20

See all quinapril hydrochloride litigation

Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 20MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 10MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 5MG BASETABLET;ORAL

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 quinapril hydrochloride
Synonyms for quinapril hydrochloride
(3S-(2(R*(R*)),3R*))-2-(2-((1-(ETHOXYCARBONYL)-3-PHENYLPROPYL)AMINO)-1-OXOPROPYL)-1,2,3,4-TETRAHYDRO-3-ISOQUINOLINECARBOXYLIC ACID MONOHYDROCHLORIDE
(3S)-2-(N-{(1S)-1-[(ethyloxy)carbonyl]-3-phenylpropyl}-L-alanyl)-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid hydrochloride
(3S)-2-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic Acid Hydrochloride
(3S)-2-[(2S)-2-[[(1S)-1-ethoxycarbonyl-3-phenyl-propyl]amino]propanoyl]-3,4-dihydro-1H-isoquinoline-3-carboxylic acid hydrochloride
(3S)-2-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]-3,4-dihydro-1H-isoquinoline-3-carboxylic acid hydrochloride
(3S)-2-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]-3,4-dihydro-1H-isoquinoline-3-carboxylic acid;hydrochloride
(3S)-2-[(2S)-2-{[(2S)-1-ETHOXY-1-OXO-4-PHENYLBUTAN-2-YL]AMINO}PROPANOYL]-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACID HYDROCHLORIDE
(3S)-2-{(2S)-2-[(1S)-1-ethoxycarbonyl-3-phenylpropylamino]propanoyl}-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid hydrochloride
(3S)-2-{N-[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]-L-alanyl}-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid hydrochloride
(S)-2-(((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-L-alanyl)-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid hydrochloride
(S)-2-((S)-2-((S)-1-ethoxy-1-oxo-4-phenylbutan-
(S)-2-((S)-2-((S)-1-ethoxy-1-oxo-4-phenylbutan-2-ylamino)propanoyl)-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid hydrochloride
(S)-2-((S)-N-((S)-1-Carboxy-3-phenylpropyl)alanyl)-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, 1-ethyl ester, monohydrochloride
(S)-2-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic Acid 1-Ethyl Ester Hydrochloride
[3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride
2-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid
2-ylamino)propanoyl)-1,2,3,4-
3-isoquinolineacrboxylic acid, 2-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)-1,2,3,4-tetrahydro-, (3S-(2(R*(R*)),3R*))-
3-Isoquinolinecarboxylic acid, 1,2,3,4-tetrahydro-2-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)-, monohydrochloride, (3S-(2(R*(R*)),3R*))-
3-Isoquinolinecarboxylic acid, 2-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)-1,2,3,4-tetrahydro-, monohydrochloride, (3S-(2(R*(R*)),3R*))
3-Isoquinolinecarboxylic acid, 2-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)-1,2,3,4-tetrahydro-, monohydrochloride, (3S-(2(R*(R*)),3R*))-
3-isoquinolinecarboxylicacid,1,2,3,4-tetrahydro-2-(2-((1-(ethoxycarbonyl)-3-p
33067B3N2M
586Q558
82586-55-8
AB07655
AB2000675
AC-1655
AC1L1HXI
Accupril
Accupril (TN)
Accuprin
Accupro
Accupron
Accuretic
Acequin
Acuitel
Acuprel
AKOS015888532
AN-14706
AS-14026
Asig
BC206223
C07340
C25H30N2O5.HCl
CAS-82586-55-8
CCG-39543
CHEBI:8714
CHEMBL1201011
CI 906
CI-906
CI-906 (CN-109452)
CI906
Conan
Continucor
CPD000499582
CS-2591
D00459
DSSTox_CID_1221
DSSTox_GSID_21221
DSSTox_RID_76019
DTXSID3021221
Ectren
Hemokvin
HMS1922C15
HSDB 7046
HY-B0477
IBBLRJGOOANPTQ-JKVLGAQCSA-N
Korec
Koretic
Lidaltrin
LS-85471
MCULE-2623123657
MFCD00889215
MLS001076683
MolPort-003-666-434
monohydrochloride,(3s-(2(r*(r*)),3r*))-henylpropyl)amino)-1-oxopropyl)
NC00722
NCGC00094997-01
NCGC00167962-06
NCGC00257944-01
NE45380
NSC-758222
NSC758222
PD 109452-2
PD-109,452-2
PD-109522
Pharmakon1600-01503076
Quinapril hydrochloride
Quinapril (hydrochloride)
Quinapril for peak identification, European Pharmacopoeia (EP) Reference Standard
Quinapril for system suitability, European Pharmacopoeia (EP) Reference Standard
QUINAPRIL HCL
Quinapril Hydrochloride ,(S)
Quinapril hydrochloride (Accupril)
Quinapril hydrochloride (JP17/USP)
Quinapril hydrochloride [USAN:USP]
Quinapril hydrochloride [USAN]
quinapril hydrochloride hydrochloride
Quinapril hydrochloride, >=98% (HPLC), solid
Quinapril hydrochloride, European Pharmacopoeia (EP) Reference Standard
Quinapril Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Quinapril hydrochloride, United States Pharmacopeia (USP) Reference Standard
Quinapril hydrochloride;
Quinapril N-Oxide
Quinapril.HCl
Quinazil
s2581
SAM002589972
SC-17215
SCHEMBL41404
SMR000499582
SPECTRUM1503076
SR-01000765404
SR-01000765404-2
SW199393-2
tetrahydroisoquinoline-3-carboxylic
Tox21_111381
Tox21_111381_1
Tox21_200390
UNII-33067B3N2M
Paragraph IV (Patent) Challenges for QUINAPRIL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ACCUPRIL TABLET;ORAL quinapril hydrochloride 019885

US Patents and Regulatory Information for quinapril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076694-001 Dec 23, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 077690-001 Jun 20, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Yaopharma Co Ltd QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076803-002 Mar 2, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076459-003 Dec 22, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Prinston Inc QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 205823-002 Sep 15, 2016 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 quinapril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-001 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-001 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-003 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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