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

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	26
Patent Applications:	5,970
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in quinapril hydrochloride?	quinapril hydrochloride excipients list
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
The Hospital for Sick Children	Phase 3

See all quinapril hydrochloride clinical trials

Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	EQ 40MG BASE	TABLET;ORAL
See Plans and Pricing	See Plans and Pricing	EQ 20MG BASE	TABLET;ORAL
See Plans and Pricing	See Plans and Pricing	EQ 10MG 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

US Patents and Regulatory Information for quinapril hydrochloride

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Glossary

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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

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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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