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Serving leading biopharmaceutical companies globally:

Chubb
Cipla
Julphar
QuintilesIMS
McKesson
Daiichi Sankyo
Deloitte
Argus Health
Merck
Johnson and Johnson

Generated: November 18, 2017

DrugPatentWatch Database Preview

Inspra Drug Profile

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What is the patent landscape for Inspra, and when can generic versions of Inspra launch?

Inspra is a drug marketed by Gd Searle Llc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in INSPRA is eplerenone. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-001Sep 27, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-001Sep 27, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-002Sep 27, 2002ABRXYesYes► Subscribe► SubscribeY► 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
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 2002DISCNNoNo► Subscribe► SubscribeY► 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 Patents for Tradename: INSPRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-001Sep 27, 2002► Subscribe► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 2002► Subscribe► Subscribe
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-002Sep 27, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for INSPRA

Drugname Dosage Strength RLD Submissiondate
eplerenoneTablets25 mg and 50 mgInspra9/27/2006

Non-Orange Book Patents for Tradename: INSPRA

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 Tradename: INSPRA

Country Document Number Estimated Expiration
Hong Kong1041641► Subscribe
Hong Kong1042252► Subscribe
Indonesia30115► Subscribe
Japan2002538172► Subscribe
Spain2207977► Subscribe
Australia1714000► Subscribe
Iceland5953► Subscribe
Malaysia125651► Subscribe
Austria249223► Subscribe
Canada2326842► 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: INSPRA

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:

McKinsey
Julphar
Medtronic
US Army
Deloitte
Harvard Business School
Dow
Cerilliant
Merck
Fish and Richardson

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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