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Federal Trade Commission
Mallinckrodt
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Generated: May 21, 2018

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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 eplerenone freedom to operate?

Eplerenone
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex, Mylan Pharms Inc, Sandoz, and Gd Searle Llc, and is included in five 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 four drug master file entries for eplerenone. Eleven suppliers are listed for this compound.
Summary for eplerenone
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
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
D0Q4SD
DB00700
DR002506
DSSTox_CID_26094
DSSTox_GSID_46094
DSSTox_RID_81333
DTXSID2046094
E0905
Epleremone
Eplerenone (JAN/USAN/INN)
Eplerenone (JP17/USAN/INN)
Eplerenone [USAN:INN:BAN]
Eplerenone [USAN]
Eplerenone, >=98% (HPLC)
Epoxymexrenone
Epoxymexrenone;CGP30083;SC-66110
GTPL2876
HSDB 7522
HY-B0251
Inspra
Inspra (TN)
Inspra, Epoxymexrenone, CGP30083, SC-66110,Eplerenone
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 (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),(1)?.0(2),?.0(1)(1),(1)?]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
PL041004
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

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apotex EPLERENONE eplerenone TABLET;ORAL 078482-001 Jul 30, 2008 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 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 ➤ Try a Free Trial ➤ Try a Free Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for eplerenone

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 ➤ Try a Free Trial
6,863,902 Immediate release eplerenone compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for eplerenone

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
04C/008 Belgium ➤ Try a Free Trial PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316
1135139/01 Switzerland ➤ Try a Free Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
QuintilesIMS
Moodys
Citi
Colorcon
Argus Health
McKesson
Dow

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.