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Last Updated: October 20, 2020

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ALDACTONE Drug 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the spironolactone profile page.

US ANDA 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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Drug patent expirations by year for ALDACTONE
Drug Prices for ALDACTONE

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Recent Clinical Trials for ALDACTONE

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SponsorPhase
Alzheimer's AssociationPhase 4
Emory UniversityPhase 4
Chiang Mai UniversityPhase 3

See all ALDACTONE clinical trials

Pharmacology for ALDACTONE

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
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