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Last Updated: February 18, 2020

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Eplerenone - Generic Drug Details

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What are the generic drug sources for eplerenone and what is the scope of freedom to operate?

Eplerenone is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex, Breckenridge, Mylan, Sandoz, and Gd Searle Llc, and is included in six NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Eplerenone has eighty-two patent family members in twenty-nine countries.

There are five drug master file entries for eplerenone. Eight suppliers are listed for this compound.

Drug Prices for eplerenone

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Recent Clinical Trials for eplerenone

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SponsorPhase
University of MichiganPhase 2
Brigham and Women's HospitalPhase 2
Bispebjerg HospitalPhase 4

See all eplerenone clinical trials

Recent Litigation for eplerenone

Identify potential future generic entrants

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

See all eplerenone litigation

Pharmacology for eplerenone
Synonyms for eplerenone
(+)-Eplerenone
(7?,11?,17?)-9,11-Epoxy-17-hydroxy-3-oxo-pregn-4-ene-7,21-dicarboxylic acid ?-lactone methyl ester
(7|A,11|A,17|A)-9,11-Epoxy-17-hydroxy-3-oxopregn-4-ene-7,21-dicarboxylic Acid
(7alpha, 11alpha, 17alpha)-9,11-epoxy-17-hydroxy-3-oxopregn-4-ene-7,21-dicarboxylate-gamma-lactone
107724-20-9
54272-EP2270011A1
54272-EP2298779A1
54272-EP2308562A2
6995V82D0B
724E209
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
AB0069122
AB01274707_02
AB01274707-01
AB2000235
AC-4213
AC1L442I
AC1L9FDC
AKOS015895219
AKOS015962307
AKOS025310162
AN-1071
API0002570
AS-13325
AS-14088
AS-33118
AX8041152
BC210409
BCP07126
BDBM50318300
BRD-A39969961-001-01-3
BRD-K82139003-001-01-7
C12512
C19H21FN2O2
CAS-107724-20-9
Cgp 30083
CGP-30083
CGP30083
CHEBI:31547
CHEBI:91683
CHEMBL1095097
CS-2231
CTK8E8647
D01115
DB00700
DSSTox_CID_26094
DSSTox_GSID_46094
DSSTox_RID_81333
DTXSID2046094
E0905
Epleremone
Eplerenone (JP17/USAN/INN)
Eplerenone [USAN:INN:BAN]
Eplerenone [USAN]
Eplerenone, >=98% (HPLC)
Epoxymexrenone
Epoxymexrenone;CGP30083;SC-66110
FT-0080368
GTPL2876
H899
HMS3269A11
HSDB 7522
HY-B0251
I06-0211
Inspra
Inspra (TN)
J-002006
J90057
JUKPWJGBANNWMW-VWBFHTRKSA-N
KS-1406
LS-172058
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 4a,6a-dimethyl-2,5'-dioxo-2,4,4',4a,5',5a,6,6a,8,9,9a,9b,10,11-tetradecahydro-3H,3'H-spiro[cyclopenta[7,8]phenanthro[4b,5-b]oxirene-7,2'-furan]-10-carboxylate
methyl dimethyl-5'-dioxo-spiro[[?]-[?],2'-tetrahydrofuran]carboxylate
MolPort-003-986-216
MolPort-006-167-612
MolPort-035-394-839
NCGC00159559-02
NCGC00159559-03
Pregn-4-ene-7,21-dicarboxylic acid 9,11-epoxy-17-hydroxy-3-oxo gamma-lactone methyl ester
Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, gamma-lactone, methyl ester, (7alpha,11alpha,17alpha)-
RTR-001855
s1707
SC 6110
SC-66110
SC-6611O
SCHEMBL14284883
SCHEMBL18382990
SCHEMBL21515
SCHEMBL8175261
SCHEMBL8445849
Selara
SR-01000942233
SR-01000942233-1
STL451057
TL8000270
Tox21_111746
Tox21_111746_1
TR-001855
UNII-6995V82D0B
YNU
ZINC15657738
ZINC3985982
Paragraph IV (Patent) Challenges for EPLERENONE
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 eplerenone

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 021437-003 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 021437-002 Sep 27, 2002 AB RX Yes Yes   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
Accord Hlthcare EPLERENONE eplerenone TABLET;ORAL 206922-001 Jul 13, 2017 AB RX No No   Start Trial   Start Trial   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
Mylan EPLERENONE eplerenone TABLET;ORAL 203896-002 Feb 2, 2017 AB RX No No   Start Trial   Start Trial   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 eplerenone

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 021437-002 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for eplerenone

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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