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

Last Updated: December 11, 2024

Spironolactone - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Amneal, Pfizer, 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, and Zydus Pharms, and is included in twenty-six 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. Forty-four suppliers are listed for this compound.

Drug Prices for spironolactone

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

SponsorPhase
CMP Development, LLCPhase 4
University of California, San FranciscoPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)N/A

See all spironolactone clinical trials

Pharmacology for spironolactone
Drug ClassAldosterone Antagonist
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for spironolactone
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
Watson Labs SPIRONOLACTONE spironolactone TABLET;ORAL 086898-002 Mar 2, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cmp Dev Llc CAROSPIR spironolactone SUSPENSION;ORAL 209478-001 Aug 4, 2017 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amneal Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 091426-003 Jul 2, 2010 AB RX 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

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

International Patents for spironolactone

Country Patent Number Title Estimated Expiration
European Patent Office 3368045 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) ⤷  Sign Up
European Patent Office 3368045 ⤷  Sign Up
Canada 3003028 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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.