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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Express Scripts
Accenture
Fish and Richardson
Teva
Covington
Citi
Chinese Patent Office
UBS
Novartis

Generated: December 16, 2017

DrugPatentWatch Database Preview

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 Accord Hlthcare, Apotex, Mylan Pharms Inc, Sandoz, and Gd Searle Llc, 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.

Pharmacology for eplerenone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
SandozEPLERENONEeplerenoneTABLET;ORAL078510-002Aug 1, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle LlcINSPRAeplerenoneTABLET;ORAL021437-001Sep 27, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
SandozEPLERENONEeplerenoneTABLET;ORAL078510-001Aug 1, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncEPLERENONEeplerenoneTABLET;ORAL203896-002Feb 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle LlcINSPRAeplerenoneTABLET;ORAL021437-001Sep 27, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Mylan Pharms IncEPLERENONEeplerenoneTABLET;ORAL203896-001Feb 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle LlcINSPRAeplerenoneTABLET;ORAL021437-003Sep 27, 2002DISCNNoNo► Subscribe► SubscribeY► Subscribe
Accord HlthcareEPLERENONEeplerenoneTABLET;ORAL206922-002Jul 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle LlcINSPRAeplerenoneTABLET;ORAL021437-001Sep 27, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
ApotexEPLERENONEeplerenoneTABLET;ORAL078482-001Jul 30, 2008ABRXNoNo► Subscribe► Subscribe► 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 LlcINSPRAeplerenoneTABLET;ORAL021437-003Sep 27, 2002► Subscribe► Subscribe
Gd Searle LlcINSPRAeplerenoneTABLET;ORAL021437-001Sep 27, 2002► Subscribe► Subscribe
Gd Searle LlcINSPRAeplerenoneTABLET;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
China1329494► Subscribe
Czech Republic20011942► Subscribe
China1230179► Subscribe
Germany60005159► Subscribe
Canada2326842► Subscribe
Argentina029155► Subscribe
Germany69911240► Subscribe
Brazil9915964► Subscribe
European Patent Office1165136► Subscribe
Norway20012229► 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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Serving leading biopharmaceutical companies globally:

Novartis
Cerilliant
Cipla
Julphar
Covington
Medtronic
Citi
US Army
AstraZeneca
QuintilesIMS

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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