Last Updated: November 8, 2026

HYDRALAZINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for hydralazine hydrochloride and what is the scope of freedom to operate?

Hydralazine hydrochloride is the generic ingredient in twenty-eight branded drugs marketed by Novartis, Abraxis Pharm, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Kindos, Navinta Llc, Pharmobedient, Rising, Smith And Nephew, Solopak, Teva Parenteral, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms, Strides Pharma, Strides Pharma Intl, Superpharm, Tp Anda Holdings, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, Mylan, Sandoz, Sun Pharm Industries, Lederle, Azurity, Ingenus Pharms Llc, and Pharmazone, and is included in one hundred and twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

Forty-two suppliers are listed for this compound.

Summary for HYDRALAZINE HYDROCHLORIDE
Drug Prices for HYDRALAZINE HYDROCHLORIDE

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Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE

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SponsorPhase
Tanta UniversityPHASE1
University of AbujaPHASE4
University of CambridgePHASE4

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Pharmacology for HYDRALAZINE HYDROCHLORIDE
Drug ClassArteriolar Vasodilator
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for HYDRALAZINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for HYDRALAZINE HYDROCHLORIDE

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heritage Pharms Inc HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 040858-003 Feb 26, 2010 AA RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 209251-004 Jul 9, 2018 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alkem Labs Ltd HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 200737-001 Dec 7, 2012 AA RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva DRALZINE hydralazine hydrochloride TABLET;ORAL 084301-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quantum Pharmics HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088686-001 May 1, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Halsey HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 089178-001 Jan 15, 1986 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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