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Last Updated: July 26, 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 patent protection?

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, 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. 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
University of NebraskaPhase 4
PfizerN/A
PfizerPhase 3

See all quinapril hydrochloride clinical trials

Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever TrialEQ 40MG BASETABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever TrialEQ 20MG BASETABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever 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
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
Sun Pharm Inds Ltd QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 090800-003 Jun 18, 2009 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Invagen Pharms QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 078457-002 Aug 24, 2007 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Yaopharma Co Ltd QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076803-004 Mar 2, 2005 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lupin QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 077690-002 Jun 20, 2006 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 019885-002 Nov 19, 1991 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-003 Nov 19, 1991 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-001 Nov 19, 1991 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Baxter
Dow
Colorcon
Johnson and Johnson

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