SPIRONOLACTONE - Generic Drug Details

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What are the generic sources for spironolactone and what is the scope of freedom to operate?

Spironolactone is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Amneal, Pfizer, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Norvium Bioscience, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in twenty-six 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. Forty-three suppliers are listed for this compound.

Summary for SPIRONOLACTONE

International Patents:	4
US Patents:	8
Tradenames:	3
Applicants:	24
NDAs:	26
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	263
Patent Applications:	6,730
Drug Prices:	Drug price trends for SPIRONOLACTONE
Drug Sales Revenues:	Drug sales revenues for SPIRONOLACTONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPIRONOLACTONE
What excipients (inactive ingredients) are in SPIRONOLACTONE?	SPIRONOLACTONE excipients list
DailyMed Link:	SPIRONOLACTONE at DailyMed

See drug prices for SPIRONOLACTONE

Drug Sales Revenue Trends for SPIRONOLACTONE

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Recent Clinical Trials for SPIRONOLACTONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CMP Development, LLC	Phase 4
University of California, San Francisco	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	N/A

See all SPIRONOLACTONE clinical trials

Pharmacology for SPIRONOLACTONE

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for SPIRONOLACTONE

Diuretics
Mineralocorticoid Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SPIRONOLACTONE

C03DA	Aldosterone antagonists
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

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

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Glossary

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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	012151-010	Dec 30, 1983	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	SPIRONOLACTONE	spironolactone	TABLET;ORAL	203512-002	Sep 19, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lederle	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087634-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	SPIRONOLACTONE	spironolactone	TABLET;ORAL	040424-003	Aug 20, 2001	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	SPIRONOLACTONE	spironolactone	TABLET;ORAL	091426-003	Jul 2, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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
Nova Laboratories Ireland Limited	Qaialdo	spironolactone	EMEA/H/C/005535 In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).	Authorised	no	no	no	2023-05-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for SPIRONOLACTONE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3368045	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)	⤷ Sign Up
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2017075463		⤷ Sign Up
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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