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Last Updated: February 21, 2020

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CAPTOPRIL; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Captopril; hydrochlorothiazide is the generic ingredient in five branded drugs marketed by Apothecon, Acp Nimble, Ivax Sub Teva Pharms, Mylan, Vintage Pharms Llc, and Watson Labs, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for captopril; hydrochlorothiazide. One supplier is listed for this compound.

Recent Clinical Trials for CAPTOPRIL; HYDROCHLOROTHIAZIDE

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

SponsorPhase
West China HospitalPhase 4
Vanderbilt University Medical CenterPhase 1/Phase 2
VA Office of Research and DevelopmentN/A

See all CAPTOPRIL; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for CAPTOPRIL; HYDROCHLOROTHIAZIDE

US Patents and Regulatory Information for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vintage Pharms Llc CAPTOPRIL AND HYDROCHLOROTHIAZIDE captopril; hydrochlorothiazide TABLET;ORAL 074788-002 Dec 29, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Apothecon CAPOZIDE 50/25 captopril; hydrochlorothiazide TABLET;ORAL 018709-003 Oct 12, 1984 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan CAPTOPRIL AND HYDROCHLOROTHIAZIDE captopril; hydrochlorothiazide TABLET;ORAL 074896-003 Dec 29, 1997 RX No No   Start Trial   Start Trial   Start Trial
Apothecon CAPOZIDE 50/15 captopril; hydrochlorothiazide TABLET;ORAL 018709-004 Oct 12, 1984 DISCN Yes No   Start Trial   Start Trial   Start Trial
Acp Nimble CAPTOPRIL AND HYDROCHLOROTHIAZIDE captopril; hydrochlorothiazide TABLET;ORAL 074827-002 Dec 29, 1997 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 CAPTOPRIL; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apothecon CAPOZIDE 25/15 captopril; hydrochlorothiazide TABLET;ORAL 018709-001 Oct 12, 1984   Start Trial   Start Trial
Apothecon CAPOZIDE 25/25 captopril; hydrochlorothiazide TABLET;ORAL 018709-002 Oct 12, 1984   Start Trial   Start Trial
Apothecon CAPOZIDE 50/15 captopril; hydrochlorothiazide TABLET;ORAL 018709-004 Oct 12, 1984   Start Trial   Start Trial
Apothecon CAPOZIDE 50/25 captopril; hydrochlorothiazide TABLET;ORAL 018709-003 Oct 12, 1984   Start Trial   Start Trial
Apothecon CAPOZIDE 50/25 captopril; hydrochlorothiazide TABLET;ORAL 018709-003 Oct 12, 1984   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Colorcon
Merck
Harvard Business School
Moodys

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