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Last Updated: October 26, 2021

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Hydralazine hydrochloride - Generic Drug Details

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

Hydralazine hydrochloride is the generic ingredient in twenty-seven branded drugs marketed by Novartis, Abraxis Pharm, Akorn, Am Regent, Fresenius Kabi Usa, Hikma, I3 Pharms, Mylan Institutional, Navinta Llc, Smith And Nephew, Solopak, Teva Parenteral, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, Sandoz, Sun Pharm Industries, Lederle, and Arbor Pharms Llc, and is included in one hundred and twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for hydralazine hydrochloride. Thirty-five suppliers are listed for this compound.

Drug Prices for hydralazine hydrochloride

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Recent Clinical Trials for hydralazine hydrochloride

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

SponsorPhase
Shahid Sadoughi University of Medical Sciences and Health ServicesPhase 3
McMaster UniversityPhase 3
National Institute for Medical Research Development (NIMAD), IranPhase 3

See all hydralazine hydrochloride clinical trials

Pharmacology for hydralazine hydrochloride
Medical Subject Heading (MeSH) Categories 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
Anda Repository HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088729-001 Apr 11, 1985 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pliva HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088467-001 May 1, 1984 AA RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
West Ward HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088240-001 May 27, 1983 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Quantum Pharmics HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088657-001 Jun 15, 1984 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Actavis Grp Ptc HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 091679-001 Mar 4, 2013 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 090413-001 Dec 8, 2010 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

Express Scripts
Johnson and Johnson
Boehringer Ingelheim
Dow
Moodys
McKinsey

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