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Last Updated: January 16, 2021

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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. 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
University of NebraskaPhase 4
PfizerN/A
The University of Western AustraliaPhase 3

See all quinapril hydrochloride clinical trials

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

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
Actavis Elizabeth QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076459-003 Dec 22, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 075504-004 Aug 24, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 090800-004 Jun 18, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076049-001 Jan 14, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 090800-003 Jun 18, 2009 DISCN 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 019885-004 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-003 Nov 19, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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