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Last Updated: November 17, 2019

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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 five drug master file entries for this compound. Eight 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

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SponsorPhase
Malcom Randall VA Medical CenterEarly Phase 1
North Florida Foundation for Research and EducationEarly Phase 1
University of CincinnatiPhase 4

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Recent Litigation for INSPRA

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District Court Litigation
Case NameDate
Amgen Inc. v. Accord Healthcare, Inc.2018-06-28

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Pharmacology for INSPRA
Synonyms for INSPRA
(+)-Eplerenone
(7?,11?,17?)-9,11-Epoxy-17-hydroxy-3-oxo-pregn-4-ene-7,21-dicarboxylic acid ?-lactone methyl ester
107724-20-9
54272-EP2270011A1
54272-EP2298779A1
54272-EP2308562A2
6995V82D0B
7alpha-methoxycarbonyl-3-oxo-9,11alpha-epoxy-17alpha-pregn-4-ene-21,17-carbolactone
9,11alpha-Epoxy-17-hydroxy-3-oxo-17alpha-pregn-4-ene-7alpha,21-dicarboxylic Acid gamma-Lactone Methyl Ester
9,11alpha-Epoxy-17-hydroxy-3-oxo-17alpha-pregn-4-ene-7alpha,21-dicarboxylic acid, gamma-lactone, methyl ester
AB01274707_02
AB01274707-01
AB2000235
AC-4213
AC1L9FDC
AKOS015962307
AX8041152
BC210409
BDBM50318300
C12512
CAS-107724-20-9
Cgp 30083
CGP-30083
CGP30083
CHEBI:31547
CHEMBL1095097
CS-2231
D01115
DB00700
DSSTox_CID_26094
DSSTox_GSID_46094
DSSTox_RID_81333
DTXSID2046094
E0905
Epleremone
Eplerenone
Eplerenone (JP17/USAN/INN)
Eplerenone [USAN:INN:BAN]
Eplerenone [USAN]
Eplerenone, >=98% (HPLC)
Epoxymexrenone
Epoxymexrenone;CGP30083;SC-66110
GTPL2876
HSDB 7522
HY-B0251
Inspra (TN)
JUKPWJGBANNWMW-VWBFHTRKSA-N
KS-1406
methyl (1'R,2R,2'S,9'R,10'R,11'S,15'S,17'R)-2',15'-dimethyl-5,5'-dioxo-18'-oxaspiro[oxolane-2,14'-pentacyclo[8.8.0.0^{1,17}.0^{2,7}.0^{11,15}]octadecan]-6'-ene-9'-carboxylate
methyl (1'R,2R,2'S,9'R,10'R,11'S,15'S,17'R)-2',15'-dimethyl-5,5'-dioxo-18'-oxaspiro[oxolane-2,14'-pentacyclo[8.8.0.0;{1,17}.0;{2,7}.0;{11,15}]octadecan]-6'-ene-9'-carboxylate
methyl (4aS,4bR,5aR,6aS,7R,9aS,9bR,10R)-4a,6a-dimethyl-2,5'-dioxo-2,4,4a,4',5a,5',6,6a,8,9,9a,9b,10,11-tetradecahydro-3H,3'H-spiro[cyclopenta[1,2]phenanthro[4,4a-b]oxirene-7,2'-furan]-10-ca
methyl dimethyl-5'-dioxo-spiro[[?]-[?],2'-tetrahydrofuran]carboxylate
MolPort-003-986-216
NCGC00159559-02
NCGC00159559-03
Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, gamma-lactone, methyl ester, (7alpha,11alpha,17alpha)-
s1707
SC 6110
SC-66110
SC-6611O
SCHEMBL21515
Selara
SR-01000942233
SR-01000942233-1
TL8000270
Tox21_111746
Tox21_111746_1
UNII-6995V82D0B
YNU
ZINC3985982
Paragraph IV (Patent) Challenges for INSPRA
Tradename Dosage Ingredient NDA Submissiondate
INSPRA TABLET;ORAL eplerenone 021437 2009-06-05
INSPRA TABLET;ORAL eplerenone 021437 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
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No   Start Trial   Start Trial Y   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 DISCN No No   Start Trial   Start Trial Y   Start 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
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for INSPRA

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

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Serving leading biopharmaceutical companies globally:

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Colorcon
Johnson and Johnson
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