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Last Updated: March 28, 2024

SPIRONOLACTONE Drug Patent Profile


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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, 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.

Drug patent expirations by year for SPIRONOLACTONE
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Drug Sales Revenue Trends for SPIRONOLACTONE

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Recent Clinical Trials for SPIRONOLACTONE

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SponsorPhase
Mario Negri Institute for Pharmacological ResearchPhase 3
National Key Research and Development Program of ChinaPhase 4
Vifor PharmaPhase 3

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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
Zydus Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 205936-002 Jul 18, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries SPIRONOLACTONE spironolactone TABLET;ORAL 089424-002 Aug 11, 1999 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Superpharm SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 089137-001 Aug 26, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mutual Pharm SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087267-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087398-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087553-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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