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Last Updated: June 28, 2022

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. Eleven suppliers are listed for this compound. Additional details are available on the eplerenone profile page.

Drug patent expirations by year for INSPRA
Drug Prices for INSPRA

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Recent Clinical Trials for INSPRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of CincinnatiPhase 4
Brigham and Women's HospitalPhase 4
Malcom Randall VA Medical CenterEarly Phase 1

See all INSPRA clinical trials

Pharmacology for INSPRA
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021437-002 Sep 27, 2002 See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 See Plans and Pricing See Plans and Pricing
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 See Plans and Pricing See Plans and Pricing
>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
Turkey 200101643 See Plans and Pricing
Israel 71504 20-SPIROXANES AND ANALOGUES HAVING AN OPEN RING E,THEIR MANUFACTURE AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM See Plans and Pricing
Spain 544770 See Plans and Pricing
Canada 2348885 See Plans and Pricing
Norway 841465 See Plans and Pricing
China 1330556 See Plans and Pricing
Japan 2002531508 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INSPRA

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

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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 verification 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.