Eplerenone - Generic Drug Details

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

Eplerenone is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Annora Pharma, Breckenridge, Chartwell Rx, Prasco, Rising, Sandoz, Slate Run Pharma, Westminster Pharms, and Upjohn, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for eplerenone. Fourteen suppliers are listed for this compound.

Summary for eplerenone

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	128
Patent Applications:	5,485
Drug Prices:	Drug price trends for eplerenone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eplerenone
What excipients (inactive ingredients) are in eplerenone?	eplerenone excipients list
DailyMed Link:	eplerenone at DailyMed

See drug prices for eplerenone

Recent Clinical Trials for eplerenone

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

Sponsor	Phase
Assiut University	Phase 4
Vifor Pharma	Phase 3
Mario Negri Institute for Pharmacological Research	Phase 3

See all eplerenone clinical trials

Pharmacology for eplerenone

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for eplerenone

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

Paragraph IV (Patent) Challenges for EPLERENONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INSPRA	Injection	eplerenone	0.75 mg/mL, 100 mL vial	021437	1	2009-06-05
INSPRA	Tablets	eplerenone	25 mg and 50 mg	021437	2	2006-09-27

US Patents and Regulatory Information for eplerenone

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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
Rising	EPLERENONE	eplerenone	TABLET;ORAL	214663-001	Mar 23, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Westminster Pharms	EPLERENONE	eplerenone	TABLET;ORAL	207842-001	Oct 25, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Westminster Pharms	EPLERENONE	eplerenone	TABLET;ORAL	207842-002	Oct 25, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Annora Pharma	EPLERENONE	eplerenone	TABLET;ORAL	213812-002	Jun 2, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Slate Run Pharma	EPLERENONE	eplerenone	TABLET;ORAL	212765-002	Aug 10, 2020	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

Expired US Patents for eplerenone

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-002	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-001	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437-003	Sep 27, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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