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Last Updated: September 26, 2022

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. Eleven 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
Pfizer
The Hospital for Sick ChildrenPhase 3

See all quinapril hydrochloride clinical trials

Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 40MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 20MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 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
Actavis Elizabeth QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076459-002 Dec 22, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 076036-003 Jan 28, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Prinston Inc QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 205823-001 Sep 15, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Ltd QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 090800-002 Jun 18, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-001 Nov 19, 1991 See Plans and Pricing See Plans and Pricing
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-002 Nov 19, 1991 See Plans and Pricing See Plans and Pricing
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-003 Nov 19, 1991 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.