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Last Updated: November 22, 2024

ALDACTONE Drug Patent Profile


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

Aldactone is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ALDACTONE is spironolactone. There are sixteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the spironolactone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aldactone

A generic version of ALDACTONE was approved as spironolactone by SUN PHARM INDUSTRIES on July 23rd, 1986.

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Summary for ALDACTONE
Drug patent expirations by year for ALDACTONE
Drug Prices for ALDACTONE

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Recent Clinical Trials for ALDACTONE

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

SponsorPhase
Thomas Jefferson UniversityPhase 1
The University of Hong KongPhase 2
Hong Kong Children's HospitalPhase 2

See all ALDACTONE clinical trials

Pharmacology for ALDACTONE
Drug ClassAldosterone Antagonist
Mechanism of ActionAldosterone Antagonists

US Patents and Regulatory Information for ALDACTONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer ALDACTONE spironolactone TABLET;ORAL 012151-009 Dec 30, 1983 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer ALDACTONE spironolactone TABLET;ORAL 012151-008 Dec 30, 1982 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer ALDACTONE spironolactone TABLET;ORAL 012151-010 Dec 30, 1983 AB RX Yes Yes ⤷  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 ALDACTONE

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Withdrawn no no no 2007-06-20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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