Hydralazine hydrochloride - Generic Drug Details

What are the generic drug 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, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, Rising, 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, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mutual 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, Mylan, Sandoz, Sun Pharm Industries, Lederle, Azurity, I3 Pharms, and Riconpharma Llc, and is included in one hundred and twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for hydralazine hydrochloride. Forty-three suppliers are listed for this compound.

Summary for hydralazine hydrochloride

US Patents:	0
Tradenames:	28
Applicants:	52
NDAs:	125
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	65
Patent Applications:	1,703
Drug Prices:	Drug price trends for hydralazine hydrochloride
What excipients (inactive ingredients) are in hydralazine hydrochloride?	hydralazine hydrochloride excipients list
DailyMed Link:	hydralazine hydrochloride at DailyMed

See drug prices for hydralazine hydrochloride

Recent Clinical Trials for hydralazine hydrochloride

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

Sponsor	Phase
National Institute for Medical Research Development (NIMAD), Iran	Phase 3
McMaster University	Phase 3
Shahid Sadoughi University of Medical Sciences and Health Services	Phase 3

See all hydralazine hydrochloride clinical trials

Pharmacology for hydralazine hydrochloride

Drug Class	Arteriolar Vasodilator
Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for hydralazine hydrochloride

Antihypertensive Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for hydralazine hydrochloride

C02DB	Hydrazinophthalazine derivatives
C02D	ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

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
Novartis	APRESAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	084810-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Solvay	RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	088376-001	Oct 28, 1983		DISCN	No	No
Rising	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	040730-001	Apr 21, 2009	AP	RX	No	No
Mutual Pharm	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	088728-001	Apr 11, 1985		DISCN	No	No
Watson Labs	HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE	hydralazine hydrochloride; hydrochlorothiazide; reserpine	TABLET;ORAL	083770-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Strides Pharma	HYDRA-ZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	088961-001	Oct 21, 1985		DISCN	No	No