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Last Updated: March 29, 2024

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, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Lupin, Mylan, Prinston Inc, and Sun Pharm Inds Ltd, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for quinapril hydrochloride
Recent Clinical Trials for quinapril hydrochloride

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

SponsorPhase
AHEPA University HospitalPhase 4
University of NebraskaPhase 4
Pfizer

See all quinapril hydrochloride clinical trials

Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 40MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 20MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 10MG 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

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
Ani Pharms QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 075504-002 Aug 24, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 077690-001 Jun 20, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076240-003 Jan 26, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076803-003 Mar 2, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl Inc QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076049-003 Jan 14, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-003 Nov 19, 1991 ⤷  Try a Trial ⤷  Try a Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-001 Nov 19, 1991 ⤷  Try a Trial ⤷  Try a Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-003 Nov 19, 1991 ⤷  Try a Trial ⤷  Try a Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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