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Last Updated: February 3, 2023

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, Pfizer, 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, and Zydus Pharms, and is included in twenty-five NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Spironolactone has four patent family members in four countries.

There are sixteen drug master file entries for spironolactone. Thirty-four suppliers are listed for this compound. There is one tentative approval 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

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SponsorPhase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 4
Second Affiliated Hospital of Nanchang UniversityN/A
Fundació Sant Joan de DéuPhase 2

See all spironolactone clinical trials

Generic filers with tentative approvals for SPIRONOLACTONE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing25MG/5MLSUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for spironolactone
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
Actavis Elizabeth SPIRONOLACTONE spironolactone TABLET;ORAL 040353-003 Mar 15, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vangard SPIRONOLACTONE spironolactone TABLET;ORAL 087648-001 Feb 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ascot SPIRONOLACTONE spironolactone TABLET;ORAL 087687-001 Oct 20, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare SPIRONOLACTONE spironolactone TABLET;ORAL 203512-003 Sep 19, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for spironolactone

Country Patent Number Title Estimated Expiration
Canada 3003028 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) See Plans and Pricing
Morocco 43132 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017075463 See Plans and Pricing
European Patent Office 3368045 COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Colorcon
AstraZeneca
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Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.