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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Baxter
Fuji
Farmers Insurance
Mallinckrodt
QuintilesIMS
Accenture
Chubb
Daiichi Sankyo
Queensland Health

Generated: September 21, 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 seventy-six patent family members in twenty-nine countries.

The generic ingredient in INSPRA is eplerenone. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the eplerenone profile page.

Summary for Tradename: Inspra

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list58
Clinical Trials: see list8
Patent Applications: see list2,143
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:Inspra at DailyMed

Pharmacology for Tradename: Inspra

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 activity 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 Kong1042252► Subscribe
World Intellectual Property Organization (WIPO)0051642► Subscribe
Spain2250803► Subscribe
Austria249242► Subscribe
Norway20012229► Subscribe
China1229141► Subscribe
European Patent Office1126880► Subscribe
Brazil9915134► Subscribe
Australia763166► Subscribe
Hungary0200519► 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 500+ biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
AstraZeneca
Covington
Johnson and Johnson
Dow
UBS
Cantor Fitzgerald
Cerilliant
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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