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Last Updated: March 19, 2024

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, Amneal, 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-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 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
National Natural Science Foundation of ChinaPhase 4
Mario Negri Institute for Pharmacological ResearchPhase 3
National Key Research and Development Program of ChinaPhase 4

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
Oxford Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 040750-002 Aug 29, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx SPIRONOLACTONE spironolactone TABLET;ORAL 086809-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith SPIRONOLACTONE spironolactone TABLET;ORAL 087554-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cmp Dev Llc CAROSPIR spironolactone SUSPENSION;ORAL 209478-001 Aug 4, 2017 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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) ⤷  Try a Trial
Canada 3003028 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2017075463 ⤷  Try a Trial
Morocco 43132 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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