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Last Updated: September 25, 2023

INSPRA Drug Patent Profile


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When do Inspra patents expire, and when can generic versions of Inspra launch?

Inspra is a drug marketed by Upjohn and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Inspra

A generic version of INSPRA was approved as eplerenone by CHARTWELL RX on July 30th, 2008.

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Drug patent expirations by year for INSPRA
Drug Prices for INSPRA

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Recent Clinical Trials for INSPRA

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SponsorPhase
Darnitsa Pharmaceutical CompanyPhase 1
ACDIMA BiocenterPhase 1
University of CincinnatiPhase 4

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Pharmacology for INSPRA
Drug ClassAldosterone Antagonist
Mechanism of ActionAldosterone Antagonists
Paragraph IV (Patent) Challenges for INSPRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INSPRA Injection eplerenone 0.75 mg/mL, 100 mL vial 021437 1 2009-06-05
INSPRA Tablets eplerenone 25 mg and 50 mg 021437 2 2006-09-27

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
Upjohn INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for INSPRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for INSPRA

See the table below for patents covering INSPRA around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1061200 ⤷  Try a Trial
Eurasian Patent Organization 003266 КОМПОЗИЦИИ НА ОСНОВЕ ТОНКОИЗМЕЛЬЧЕННОГО ЭПЛЕРЕНОНА (MICRONIZED EPLERENONE COMPOSITIONS) ⤷  Try a Trial
Germany 60024335 ⤷  Try a Trial
Israel 143301 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INSPRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135139 C01135139/01 Switzerland ⤷  Try a Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0122232 91072 Luxembourg ⤷  Try a Trial 91072, EXPIRES: 20090410
0122232 300144 Netherlands ⤷  Try a Trial 300144, 20040410, EXPIRES: 20090409
0122232 2004C/008 Belgium ⤷  Try a Trial PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
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