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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
US Army
Farmers Insurance
Baxter
Argus Health
AstraZeneca
McKesson
Chubb
Cantor Fitzgerald

Generated: October 21, 2017

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Eplerenone - Generic Drug Details

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

Eplerenone
is the generic ingredient in two branded drugs marketed by Sandoz, Accord Hlthcare, Gd Searle Llc, Apotex, and Mylan Pharms Inc, and is included in five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Eplerenone has eighty-two patent family members in twenty-nine countries and two supplementary protection certificates in two countries.

There are four drug master file entries for eplerenone. Eleven suppliers are listed for this compound.

Summary for Generic Name: eplerenone

US Patents:7
Tradenames:2
Applicants:5
NDAs:5
Drug Master File Entries: see list4
Suppliers / Packagers: see list11
Bulk Api Vendors: see list38
Clinical Trials: see list93
Patent Applications: see list3,538
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:eplerenone at DailyMed

Pharmacology for Ingredient: eplerenone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
EPLERENONE
eplerenone
TABLET;ORAL206922-001Jul 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
EPLERENONE
eplerenone
TABLET;ORAL078510-002Aug 1, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 2002DISCNNoNo► Subscribe► SubscribeY► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-002Sep 27, 2002ABRXYesYes► Subscribe► SubscribeY► Subscribe
Mylan Pharms Inc
EPLERENONE
eplerenone
TABLET;ORAL203896-002Feb 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-001Sep 27, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 2002DISCNNoNo► Subscribe► SubscribeY► Subscribe
Apotex
EPLERENONE
eplerenone
TABLET;ORAL078482-002Jul 30, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 2002DISCNNoNo► Subscribe► SubscribeY► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-002Sep 27, 2002ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: eplerenone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 2002► Subscribe► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-001Sep 27, 2002► Subscribe► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-002Sep 27, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: eplerenone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,592,902 Controlled release eplerenone compositions► Subscribe
6,863,902 Immediate release eplerenone compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: eplerenone

Country Document Number Estimated Expiration
MexicoPA01009035► Subscribe
Turkey200102581► Subscribe
Australia1936800► Subscribe
Brazil0008781► Subscribe
Austria249223► Subscribe
Hong Kong1061200► Subscribe
Eurasian Patent Organization004064► Subscribe
Iceland5953► Subscribe
Spain2207977► Subscribe
Austria249242► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: EPLERENONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135139/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
04C/008Belgium► SubscribePRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Mallinckrodt
Deloitte
US Army
Medtronic
Citi
QuintilesIMS
Farmers Insurance
Daiichi Sankyo

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 verifification 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.

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