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Spironolactone - Generic Drug Details

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

Spironolactone is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Pfizer, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma Ltd, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in twenty-five NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Spironolactone has three patent family members in three countries.

There are sixteen drug master file entries for spironolactone. Thirty-nine suppliers are listed for this compound.

Summary for spironolactone

International Patents:	3
US Patents:	4
Tradenames:	3
Applicants:	22
NDAs:	25
Drug Master File Entries:	16
Suppliers / Packagers:	39
Bulk Api Vendors:	76
Clinical Trials:	213
Patent Applications:	4,373
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for spironolactone
Drug Sales Revenues:	Drug sales revenues for spironolactone
DailyMed Link:	spironolactone at DailyMed

See drug prices for spironolactone

See drug sales revenues for spironolactone

Recent Clinical Trials for spironolactone

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

Sponsor	Phase
Alzheimer's Association	Phase 4
Emory University	Phase 4
Chiang Mai University	Phase 3

See all spironolactone clinical trials

Pharmacology for spironolactone

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for spironolactone

Diuretics

Mineralocorticoid Receptor Antagonists

US Patents and Regulatory Information for spironolactone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017		RX	Yes	Yes			Y
Oxford Pharms	SPIRONOLACTONE	spironolactone	TABLET;ORAL	040750-002	Aug 29, 2006	AB	RX	No	No
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-010	Dec 30, 1983	AB	RX	Yes	Yes
Actavis Elizabeth	SPIRONOLACTONE	spironolactone	TABLET;ORAL	040353-003	Mar 15, 2006		DISCN	No	No
Actavis Elizabeth	SPIRONOLACTONE	spironolactone	TABLET;ORAL	040353-001	Jul 29, 1999		DISCN	No	No
Mylan	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087086-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mylan	SPIRONOLACTONE	spironolactone	TABLET;ORAL	040424-002	Aug 20, 2001	AB	RX	No	No

International Patents for spironolactone

Country	Patent Number	Estimated Expiration
European Patent Office	3368045
Canada	3003028
World Intellectual Property Organization (WIPO)	2017075463