HYDRALAZINE HYDROCHLORIDE - Generic Drug Details

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 Ltd, 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, I3 Pharms, and Ingenus Pharms Llc, and is included in one hundred and twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for HYDRALAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	28
Applicants:	54
NDAs:	127
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	68
Patent Applications:	3,646
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
Tanta University	PHASE1
University of Abuja	PHASE4
University of Cambridge	PHASE4

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
Hetero Labs Ltd Iii	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	040901-001	Sep 12, 2008	AA	RX	No	No
Chartwell Rx	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	088848-001	Feb 26, 1985		DISCN	No	No
Novartis	APRESOLINE	hydralazine hydrochloride	TABLET;ORAL	008303-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmobedient	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	090413-003	Dec 8, 2010		DISCN	No	No
Cadila Pharms Ltd	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	203845-001	Sep 18, 2014	AA	RX	No	No
Mutual Pharm	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	084107-002	Approved Prior to Jan 1, 1982		DISCN	No	No