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Last Updated: August 3, 2020

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SPIRONOLACTONE Drug Profile

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

Spironolactone is a drug marketed by 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, Zydus Pharms, Yaopharma Co Ltd, Parke Davis, and Usl Pharma. and is included in forty NDAs.

The generic ingredient in SPIRONOLACTONE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.

Drug patent expirations by year for SPIRONOLACTONE
Drug Prices 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
Lomonosov Moscow State University Medical Research and Educational CenterPhase 3
Yonsei UniversityPhase 4
Asan Medical CenterN/A

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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
Zydus Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 205936-003 Jul 18, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries SPIRONOLACTONE spironolactone TABLET;ORAL 089424-003 Aug 11, 1999 AB RX No No   Start Trial   Start Trial   Start Trial
Yaopharma Co Ltd SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086881-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087999-001 Nov 6, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Pharms SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087004-002 May 24, 1982 DISCN 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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