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Serving leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
Fish and Richardson
US Department of Justice
Fuji
Johnson and Johnson
Argus Health
AstraZeneca
Federal Trade Commission
Farmers Insurance

Generated: February 21, 2018

DrugPatentWatch Database Preview

INSPRA Drug Profile

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Which patents cover 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.

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.
Drug patent expirations by year for INSPRA
Pharmacology for INSPRA

US Patents and Regulatory Information for 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;ORAL 021437-001 Sep 27, 2002 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for INSPRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 ➤ Sign Up ➤ Sign Up
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 ➤ Sign Up ➤ Sign Up
Gd Searle Llc 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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Paragraph IV (Patent) Challenges for INSPRA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 25 mg and 50 mg ➤ Subscribe 9/27/2006

Non-Orange Book US Patents for 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 ➤ Sign Up
6,863,902 Immediate release eplerenone compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for INSPRA

Supplementary Protection Certificates for INSPRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135139/01 Switzerland ➤ Sign Up PRODUCT NAME: EPLERENON; REGISTRATION NUMBER/DATE: SWISSMEDIC 57147 12.12.2005
04C/008 Belgium ➤ Sign Up PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
McKesson
Cerilliant
UBS
Accenture
Healthtrust
Fish and Richardson
Dow
Cantor Fitzgerald

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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