Spironolactone - Generic Drug Details

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, 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 eight 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-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for spironolactone

International Patents:	4
US Patents:	8
Tradenames:	3
Applicants:	22
NDAs:	25
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	251
Patent Applications:	6,676
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

See drug sales revenues for spironolactone

Recent Clinical Trials for spironolactone

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

Sponsor	Phase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 4
Second Affiliated Hospital of Nanchang University	N/A
Fundació Sant Joan de Déu	Phase 2

See all spironolactone clinical trials

Generic filers with tentative approvals for SPIRONOLACTONE

Applicant	Application No.	Strength	Dosage Form
		25MG/5ML	SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	Strength	NDA	ANDAs Submitted	Submissiondate
CAROSPIR	Oral Suspension	spironolactone	25 mg/5 mL	209478	1	2020-12-31

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
Actavis Elizabeth	SPIRONOLACTONE	spironolactone	TABLET;ORAL	040353-003	Mar 15, 2006		DISCN	No	No
Vangard	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087648-001	Feb 1, 1982		DISCN	No	No
Ascot	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087687-001	Oct 20, 1982		DISCN	No	No
Accord Hlthcare	SPIRONOLACTONE	spironolactone	TABLET;ORAL	203512-003	Sep 19, 2016	AB	RX	No	No

EU/EMA Drug Approvals for spironolactone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ceva Santé Animale	Spironolactone Ceva	spironolactone	EMEA/V/C/000105 For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.	Withdrawn	no	no	no	2007-06-20

International Patents for spironolactone

Country	Patent Number	Title	Estimated Expiration
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE
World Intellectual Property Organization (WIPO)	2017075463
European Patent Office	3368045	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)