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Last Updated: March 31, 2020

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KORLYM Drug Profile


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Which patents cover Korlym, and what generic alternatives are available?

Korlym is a drug marketed by Corcept Therap and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in ten countries.

The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mifepristone profile page.

US ANDA Litigation and Generic Entry Outlook for Korlym

A generic version of KORLYM was approved as mifepristone by GENBIOPRO on April 11th, 2019.

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Drug patent expirations by year for KORLYM
Recent Clinical Trials for KORLYM

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

SponsorPhase
Charles Drew University of Medicine and SciencePhase 2
Johns Hopkins UniversityN/A
National Institute on Alcohol Abuse and Alcoholism (NIAAA)N/A

See all KORLYM clinical trials

Recent Litigation for KORLYM

Identify potential future generic entrants

District Court Litigation
Case NameDate
CORCEPT THERAPEUTICS, INC. v. SUN PHARMA GLOBAL FZE2019-07-22
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC.2019-02-08
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC.2018-03-15

See all KORLYM litigation

PTAB Litigation
PetitionerDate
Teva Pharmaceuticals USA, Inc.2019-05-07
Neptune Generics LLC2018-08-02

See all KORLYM litigation

Pharmacology for KORLYM
Synonyms for KORLYM
(10S,11S,14S,15S,17R)-17-[4-(dimethylamino)phenyl]-14-hydroxy-15-methyl-14-(prop-1-yn-1-yl)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-1,6-dien-5-one
(10S,11S,14S,15S,17R)-17-[4-(dimethylamino)phenyl]-14-hydroxy-15-methyl-14-(prop-1-yn-1-yl)tetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-1,6-dien-5-one
(11?,17?)-11-[4-(Dimethylamino)phenyl]-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one
(11beta,17beta)-11-(4-(Dimethylamino)-phenyl)-17-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one
(11beta,17beta)-11-(4-(Dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one
(11beta,17beta)-11-(4-(Dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one
(11beta,17beta)-11-[4-(dimethylamino)phenyl]-17-hydroxy-17-prop-1-yn-1-ylestra-4,9-dien-3-one
(11R,13S,14S,17S)-11-(4-Dimethylamino-phenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,13,14,15,16,17-dodecahydro-cyclopenta[a]phenanthren-3-one
(8S,11R,13S,14S,17S)-11-(4-(dimethylamino)phenyl)-17-hydroxy-13-methyl-17-(prop-1-yn-1-yl)-1,2,6,7,8,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one
(8S,11R,13S,14S,17S)-11-(4-dimethylaminophenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one
(8S,11R,13S,14S,17S)-11-[4-(dimethylamino)phenyl]-13-methyl-17-oxidanyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one
(8S,11R,13S,14S,17S)-11-[4-(Dimethylamino)phenyl]-17-hydroxy-13-methyl-17-(prop-1-yn-1-yl)-1,2,6,7,8,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one (non-preferred name)
(8S,11R,13S,14S,17S)-11-[4-(dimethylamino)phenyl]-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one
(non-labelled)Mifepristone-d3
11-(4-DIMETHYLAMINO-PHENYL)-17-HYDROXY-13-METHYL-17-PROP-1-YNYL-1,2,6,7,8,11,12,13,14,15,16,17-DODEC AHYDRO-CYCLOPENTA[A]PHENANTHREN-3-ONE
11.beta.-[4-(Dimethylamino)phenyl]-17.beta.-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one
11beta-(4-(Dimethylamino)phenyl)-17-hydroxy-21-methyl-19-nor-17alpha-pregna-4,9-dien-20-m-3-on
11beta-(4-(Dimethylamino)phenyl)-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-on
11beta-(4-(N,N-Dimethylamino)phenyl)-17alpha-(prop-1-ynyl)-delta4,9-estradiene-17beta-ol-3-one
11beta-(4-Dimethyl-amino)-phenyl-17beta-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one
11beta-(p-(Dimethylamino)phenyl)-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one
11ss-[p-(Dimethylamino)fenyl]-17ss-hydroxy- 17-(1-propynyl)estra-4,9-dien-3-on
17-beta-Hydroxy-11-beta-(4-dimethylaminophenyl-1)-17-alpha-(prop-1-ynyl)oestra-4,9-dien-3-one
1nhz
29523-EP2272827A1
29523-EP2275420A1
29523-EP2295055A2
29523-EP2295416A2
29523-EP2298748A2
29523-EP2298764A1
29523-EP2298765A1
29523-EP2305642A2
29523-EP2308880A1
29523-EP2311453A1
29523-EP2311808A1
29523-EP2311829A1
29523-EP2311842A2
2w8y
320T6RNW1F
371M653
75603-EP2269977A2
75603-EP2308880A1
83203-42-3
84371-65-3
A840767
AB2000695
ABP000437
ACT02598
AKOS015895416
ANW-41472
AOB6893
API0003390
ARONIS27015
AS-13938
BCP02145
BDBM18627
BDBM50072024
BIDD:PXR0123
BPBio1_000262
BRD-K37270826-001-04-5
BRD-K37270826-001-31-8
BRN 5779404
BSPBio_000238
C-1073
C07652
C29H35NO2
CAS-84371-65-3
CCG-101164
CCRIS 9332
CHEBI:50692
CHEMBL1276308
CHEMBL438575
CI-1073
Corlux
CPD000058481
CS-1435
CTK8B2959
D00585
DB00834
DSSTox_CID_3322
DSSTox_GSID_23322
DSSTox_RID_76976
DTXSID5023322
Estra-4,9-dien-3-one, 11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-, (11-beta,17-beta)-
Estra-4,9-dien-3-one, 11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-, (11beta,17beta)-
Estra-4,9-dien-3-one, 11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propynyl)-, (11b,17b)-
EU-0100801
FT-0082666
FT-0602519
GTPL2805
HMS1568L20
HMS2052L05
HMS2090L22
HMS2095L20
HMS2230P21
HMS3262B03
HMS3412D17
HMS3649J08
HMS3676D17
HMS3712L20
HSCI1_000369
HSDB 6841
HY-13683
Korlym (TN)
Lopac0_000801
LP00801
LS-64723
M 8046
MFCD00867226
Mifegyne
Mifeprex
Mifeprex (TN)
Mifepriston
Mifepristona
Mifepristona [Spanish]
mifepristone
Mifepristone (JAN/USAN/INN)
Mifepristone (Mifeprex)
Mifepristone [USAN:INN:BAN]
Mifepristone 1.0 mg/ml in Acetonitrile
Mifepristone, >=98%
Mifepristone, 98%
Mifepristone, United States Pharmacopeia (USP) Reference Standard
Mifepristone(Mifeprex)
Mifepristone(Mifeprex)/
Mifepristonum
Mifepristonum [Latin]
MLS000069785
MLS001074115
MLS001424271
NC00414
NCGC00025179-05
NCGC00025179-06
NCGC00025179-07
NCGC00025179-08
NCGC00025179-09
NCGC00025179-12
NCGC00025179-13
NCGC00179632-01
NCGC00255152-01
NCGC00261486-01
Opera_ID_562
Pictovir
Pictovir (TM)
Prestwick_570
Prestwick0_000299
Prestwick1_000299
Prestwick2_000299
Prestwick3_000299
Q-201405
Q411240
R 38486
R-38486
R38486
RU 38486
RU 486
RU 486-6
RU-38486
RU-486
RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex
RU486
RU486 (tetramethyl-rhodamine conjugated)
RU486;C-1073
s2606
SC-16222
SCHEMBL16087
SMR000058481
SPBio_002457
Spectrum5_002045
SR-01000076011
SR-01000076011-1
SR-01000076011-3
SR-01000076011-5
SR-01000076011-9
SR-01000721888
SR-01000721888-4
Tox21_110952
Tox21_110952_1
Tox21_301841
Tox21_500801
TR-026092
UNII-320T6RNW1F
VGX-410
VGX-410C
VKHAHZOOUSRJNA-GCNJZUOMSA-N
VX-410
W-5163
ZINC3831128
ZK-98296
ZK98296
Paragraph IV (Patent) Challenges for KORLYM
Tradename Dosage Ingredient NDA Submissiondate
KORLYM TABLET;ORAL mifepristone 202107 2017-12-15

US Patents and Regulatory Information for KORLYM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Express Scripts
Medtronic
Harvard Business School
Moodys

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.