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Last Updated: December 1, 2020

DrugPatentWatch Database Preview

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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What are the generic drug sources for hydralazine hydrochloride; hydrochlorothiazide and what is the scope of patent protection?

Hydralazine hydrochloride; hydrochlorothiazide is the generic ingredient in twenty-one branded drugs marketed by Novartis, Par Pharm, Solvay, Superpharm, Watson Labs, Ivax Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Sandoz, Sun Pharm Industries, and Lederle, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for hydralazine hydrochloride; hydrochlorothiazide.

Summary for HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

SponsorPhase
Vanderbilt University Medical CenterPhase 4
National Center for Research Resources (NCRR)Phase 4
Vanderbilt University Medical CenterPhase 1/Phase 2

See all HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE clinical trials

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 085457-001 Mar 4, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Pharms HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088358-001 Apr 10, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 085440-001 Mar 4, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm HYDRA-ZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088957-001 Oct 21, 1985 RX No No   Start Trial   Start Trial   Start Trial
Mylan HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 087085-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 087609-001 Feb 8, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms HYDROSERPINE PLUS (R-H-H) hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 083877-001 Approved Prior to Jan 1, 1982 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

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Baxter
Boehringer Ingelheim
Mallinckrodt
McKesson

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