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Last Updated: October 21, 2021

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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, Pfizer, 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 five 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-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
St George's, University of LondonPhase 3
Washington University School of MedicinePhase 3
University of PennsylvaniaPhase 4

See all spironolactone clinical trials

Pharmacology for spironolactone
Medical Subject Heading (MeSH) Categories for spironolactone
Paragraph IV (Patent) Challenges for SPIRONOLACTONE
Tradename Dosage Ingredient NDA Submissiondate
CAROSPIR SUSPENSION;ORAL spironolactone 209478

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
Cmp Dev Llc CAROSPIR spironolactone SUSPENSION;ORAL 209478-001 Aug 4, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Watson Labs SPIRONOLACTONE spironolactone TABLET;ORAL 086898-002 Mar 2, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Cmp Dev Llc CAROSPIR spironolactone SUSPENSION;ORAL 209478-001 Aug 4, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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:

McKesson
Express Scripts
Colorcon
AstraZeneca
Harvard Business School
Baxter

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