HYDROCHLOROTHIAZIDE; SPIRONOLACTONE - Generic Drug Details

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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, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Watson Labs, 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.

Seven 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
Ivax Pharms	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087004-002	May 24, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vangard	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087655-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	085974-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	086881-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Usl Pharma	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087651-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Parke Davis	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087948-001	Feb 22, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
DailyMed Link:	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE at DailyMed

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