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Quinapril hydrochloride - Generic Drug Details
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.
Summary for quinapril hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 14 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 26 |
| Patent Applications: | 2,468 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for quinapril hydrochloride |
| DailyMed Link: | quinapril hydrochloride at DailyMed |
Recent Clinical Trials for quinapril hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Nebraska | Phase 4 |
| Pfizer | N/A |
| British Heart Foundation | Phase 3 |
Recent Litigation for quinapril hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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 |
Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 20MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 10MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 5MG BASE | TABLET;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
| Drug Class | Angiotensin Converting Enzyme Inhibitor |
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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