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HYDROCHLOROTHIAZIDE; SPIRONOLACTONE - Generic Drug Details

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

Hydrochlorothiazide; spironolactone is the generic ingredient in three branded drugs marketed by Pfizer, Ascot, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Watson Labs, Yaopharma Co Ltd, Ivax Pharms, Lederle, Parke Davis, Upsher Smith, Usl Pharma, and Vangard, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide; spironolactone. Six suppliers are listed for this compound.

Sponsor	Phase
Chiang Mai University	Phase 3
Medical University of Bialystok	N/A
Shanghai Jiao Tong University School of Medicine	Phase 4

Sponsor

Phase

Chiang Mai University

Phase 3

Medical University of Bialystok

N/A

Shanghai Jiao Tong University School of Medicine

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ALDACTAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	012616-005	Dec 30, 1982		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Upsher Smith	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087553-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Parke Davis	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087948-001	Feb 22, 1983		DISCN	No	No	Start Trial	Start Trial				Start Trial
Purepac Pharm	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087999-001	Nov 6, 1985		DISCN	No	No	Start Trial	Start Trial				Start Trial
Purepac Pharm	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	088054-001	Aug 18, 1983		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

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	18
Drug Master File Entries:	32
Suppliers / Packagers:	6
Bulk Api Vendors:	1
Clinical Trials:	9
Patent Applications:	28
DailyMed Link:	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE at DailyMed

Drug Class	Aldosterone Antagonist Thiazide Diuretic
Mechanism of Action	Aldosterone Antagonists
Physiological Effect	Increased Diuresis