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Last Updated: November 12, 2024

SPIRONOLACTONE - Generic Drug Details


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What are the generic sources for spironolactone and what is the scope of freedom to operate?

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-three suppliers are listed for this compound.

Drug Prices for SPIRONOLACTONE

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Drug Sales Revenue Trends for SPIRONOLACTONE

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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
Jubilant Generics SPIRONOLACTONE spironolactone TABLET;ORAL 203253-003 Apr 23, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 205936-001 Jul 18, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan SPIRONOLACTONE spironolactone TABLET;ORAL 040424-001 Aug 20, 2001 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
Canada 3003028 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) ⤷  Sign Up
Morocco 43132 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE ⤷  Sign Up
European Patent Office 3368045 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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