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Last Updated: November 21, 2019

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Hydrochlorothiazide; quinapril hydrochloride - Generic Drug Details

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What are the generic drug sources for hydrochlorothiazide; quinapril hydrochloride and what is the scope of freedom to operate?

Hydrochlorothiazide; quinapril hydrochloride is the generic ingredient in three branded drugs marketed by Pfizer Pharms, Apotex Corp, Aurobindo Pharma, Invagen Pharms, Mylan, Sun Pharm Inds Ltd, and Lupin, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide; quinapril hydrochloride. Seven suppliers are listed for this compound.

Recent Clinical Trials for hydrochlorothiazide; quinapril hydrochloride

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

SponsorPhase
LaborMed Pharma S.A.Phase 4
Vanderbilt University Medical CenterPhase 4
National Center for Research Resources (NCRR)Phase 4

See all hydrochlorothiazide; quinapril hydrochloride clinical trials

Recent Litigation for hydrochlorothiazide; quinapril hydrochloride

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District Court Litigation
Case NameDate
Apotex, Inc. v. UCB, Inc.2012-04-20
Apotex, Inc. v. Mylan Pharmaceuticals, Inc.2012-04-20
Fleetwood Enterprises, Inc.2009-03-10

See all hydrochlorothiazide; quinapril hydrochloride litigation

Pharmacology for hydrochlorothiazide; quinapril hydrochloride
Synonyms for hydrochlorothiazide; quinapril hydrochloride
C25H30N2O5.C7H8ClN3O4S2.Cl
LS-178473
SCHEMBL2526759
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ACCURETIC TABLET;ORAL hydrochlorothiazide; quinapril hydrochloride 020125

US Patents and Regulatory Information for hydrochlorothiazide; quinapril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin QUINARETIC hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 076374-002 Mar 31, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 078450-001 Aug 24, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Pfizer Pharms ACCURETIC hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 020125-001 Dec 28, 1999 AB RX Yes 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 hydrochlorothiazide; quinapril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms ACCURETIC hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 020125-001 Dec 28, 1999   Start Trial   Start Trial
Pfizer Pharms ACCURETIC hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 020125-002 Dec 28, 1999   Start Trial   Start Trial
Pfizer Pharms ACCURETIC hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 020125-003 Dec 28, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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