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Last Updated: August 12, 2020

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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, Gd Searle Llc, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma Ltd, 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-five NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Spironolactone has three patent family members in three countries.

There are sixteen drug master file entries for spironolactone. Thirty-eight 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
Lomonosov Moscow State University Medical Research and Educational CenterPhase 3
Yonsei UniversityPhase 4
Asan Medical CenterN/A

See all spironolactone clinical trials

Pharmacology for spironolactone
Medical Subject Heading (MeSH) Categories for spironolactone

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
Ivax Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 087108-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs SPIRONOLACTONE spironolactone TABLET;ORAL 087078-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ascot SPIRONOLACTONE spironolactone TABLET;ORAL 087687-001 Oct 20, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Gd Searle Llc ALDACTONE spironolactone TABLET;ORAL 012151-008 Dec 30, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Zydus Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 205936-002 Jul 18, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Cmp Dev Llc CAROSPIR spironolactone SUSPENSION;ORAL 209478-001 Aug 4, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm Industries SPIRONOLACTONE spironolactone TABLET;ORAL 089424-003 Aug 11, 1999 AB RX No No   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:

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Merck

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