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Last Updated: October 21, 2021

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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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Spironolactone has four patent family members in four countries.

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

Summary for spironolactone

International Patents:	4
US Patents:	5
Tradenames:	3
Applicants:	22
NDAs:	25
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	229
Patent Applications:	6,987
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for spironolactone
Drug Sales Revenues:	Drug sales revenues for spironolactone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for spironolactone
What excipients (inactive ingredients) are in spironolactone?	spironolactone excipients list
DailyMed Link:	spironolactone at DailyMed

See drug prices for spironolactone

Drug Sales Revenue Trends for spironolactone

See drug sales revenues for spironolactone

Recent Clinical Trials for spironolactone

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

Sponsor	Phase
St George's, University of London	Phase 3
Washington University School of Medicine	Phase 3
University of Pennsylvania	Phase 4

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

Paragraph IV (Patent) Challenges for SPIRONOLACTONE

Tradename	Dosage	Ingredient	NDA	Submissiondate
CAROSPIR	SUSPENSION;ORAL	spironolactone	209478

US Patents and Regulatory Information for spironolactone

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Glossary

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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
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
Watson Labs	SPIRONOLACTONE	spironolactone	TABLET;ORAL	086898-002	Mar 2, 1982		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for spironolactone

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Country	Patent Number	Estimated Expiration
European Patent Office	3368045	⤷ Try it Free
Canada	3003028	⤷ Try it Free
World Intellectual Property Organization (WIPO)	2017075463	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.