You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

SPIRONOLACTONE Drug Patent Profile

✉ Email this page to a colleague

« Back to Dashboard

Which patents cover Spironolactone, and what generic alternatives are available?

Spironolactone is a drug marketed by Amneal, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Norvium Bioscience, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, Zydus Pharms, Parke Davis, and Usl Pharma. and is included in forty-one NDAs.

The generic ingredient in SPIRONOLACTONE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for SPIRONOLACTONE?
What are the global sales for SPIRONOLACTONE?
What is Average Wholesale Price for SPIRONOLACTONE?

Summary for SPIRONOLACTONE

US Patents:	0
Applicants:	24
NDAs:	41
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	263
Patent Applications:	3,086
Drug Prices:	Drug price information 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

Drug patent expirations by year for SPIRONOLACTONE

Drug Prices for SPIRONOLACTONE

Recent Clinical Trials for SPIRONOLACTONE

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

Sponsor	Phase
CMP Development, LLC	Phase 4
University of California, San Francisco	Phase 2
Yale University	N/A

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

Anatomical Therapeutic Chemical (ATC) Classes for SPIRONOLACTONE

C03DA	Aldosterone antagonists
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

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

+ Get email alerts for changes to this table

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	SPIRONOLACTONE	spironolactone	TABLET;ORAL	205936-002	Jul 18, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	SPIRONOLACTONE	spironolactone	TABLET;ORAL	089424-002	Aug 11, 1999	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Superpharm	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	089137-001	Aug 26, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mutual Pharm	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087267-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087398-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087553-001	Approved Prior to Jan 1, 1982		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

EU/EMA Drug Approvals for SPIRONOLACTONE

Subscribe to access the full database, or Sign Up
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
Nova Laboratories Ireland Limited	Qaialdo	spironolactone	EMEA/H/C/005535 In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).	Authorised	no	no	no	2023-05-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

Make Better Decisions: Try a trial or see plans & pricing

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.