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Last Updated: November 18, 2019

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CLOBEX Drug Profile

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

Clobex is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in three NDAs. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has thirty-two patent family members in twenty-one countries.

The generic ingredient in CLOBEX is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Drug patent expirations by year for CLOBEX
Drug Prices for CLOBEX

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Drug Sales Revenue Trends for CLOBEX

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Recent Clinical Trials for CLOBEX

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SponsorPhase
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)Phase 1
University of California, San FranciscoPhase 4
Galderma LaboratoriesPhase 4

See all CLOBEX clinical trials

Recent Litigation for CLOBEX

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories LP v. Akorn Inc2016-04-14
Galderma Laboratories LP v. Teligent Inc2015-12-04
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-08

See all CLOBEX litigation

Pharmacology for CLOBEX
Synonyms for CLOBEX
(11b,16b)-21-Chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione
[(8S,9R,10S,11S,13S,14S,16S,17R)-17-(2-chloroacetyl)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
122C467
21-chloro-9-fluoro-11 beta-hydroxy-16 beta-methylpregna-1,4-diene-3,20-dione 17-propionate
21-Chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione (11beta,16beta)-
21-Chloro-9-fluoro-11b,17-dihydroxy-16b-methylpregna-1,4-diene-3,20-dione 17-propionate
21-chloro-9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-dien-17-yl propanoate
21-Chloro-9-fluoro-11beta-hydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-propionate
21-Chloro-9-fluoro-11beta,17-dihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-propionate
21-Chloro-9alpha-fluoro-11beta,17alpha-dihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17-Propionate
25122-46-7
779619577M
AB00383081_11
AB00383081-10
AB1009262
AC-17990
AC1L1OG9
AC1Q3T8C
AKOS015951278
AMOT0927
AN-14318
AS-12555
BCP04125
BCP0726000094
BCP9000539
BDBM39347
BRD-K10799896-001-10-6
BRD-K10799896-001-26-2
Butavate
C-22667
C25H32ClFO5
CAS-25122-46-7
CC-25914
CCG-220781
CCI 4725
CCI-4725
CGP 9555
CGP9555 pound>> CCl 4725 pound>>CGP 9555 pound>> CCl4725 pound>>CGP-9555 pound>> CCl-4725
CHEBI:31414
CHEMBL1159650
cid_32798
Clarelux
Clobesol
Clobestasol propionate
clobetasol 17-propanoate
Clobetasol 17-propionate
Clobetasol for peak identification, European Pharmacopoeia (EP) Reference Standard
CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE (EMOLLIENT)
Clobetasol propionate (JP17/USP)
Clobetasol propionate [USAN:JAN]
Clobetasol propionate [USAN:USP:JAN]
Clobetasol propionate E
Clobetasol propionate gel
Clobetasol propionate, analytical standard
Clobetasol propionate, European Pharmacopoeia (EP) Reference Standard
Clobetasol Propionate, Pharmaceutical Secondary Standard; Certified Reference Material
Clobetasol propionate, United States Pharmacopeia (USP) Reference Standard
Clobetasole propionate
Clobetasolpropionat mikron.
Clobetasolpropionate
Cormax
Cormax (TN)
CPD000058745
CS-2594
D01272
DB01013
Dermoval
Dermovate
Dermoxinale
DSSTox_CID_25907
DSSTox_GSID_45907
DSSTox_RID_81219
DTXSID6045907
EBD6220
EINECS 246-634-3
Embeline
Embeline E
GR 2/925
GTPL7062
HMS2090A04
HMS2230H08
HMS3259A10
HMS3714M04
HY-13600
Impoyz
LS-118433
MFCD00058499
MLS000028708
MLS001076345
NC00551
NCGC00023373-03
NCGC00023373-04
NCGC00095078-01
Olux
Olux E
OLUX FOAM
Olux-E
Opera_ID_1470
Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-beta,17-dihydroxy-16-beta-methyl-, 17-propionate
Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-beta,17-dihydroxy-16-beta-methyl-,17-propionate
Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11beta,16beta)-
Propionic acid clobetasol
s2584
SCHEMBL3997
SMR000058745
SR-01000000280
SR-01000000280-4
Temovate
Temovate E
Tox21_111414
Tox21_111414_1
UNII-779619577M
Yugofin
ZINC3977767
Paragraph IV (Patent) Challenges for CLOBEX
Tradename Dosage Ingredient NDA Submissiondate
CLOBEX SPRAY;TOPICAL clobetasol propionate 021835 2008-09-29
CLOBEX SHAMPOO;TOPICAL clobetasol propionate 021644 2008-01-09
CLOBEX LOTION;TOPICAL clobetasol propionate 021535 2006-03-27

US Patents and Regulatory Information for CLOBEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp CLOBEX clobetasol propionate LOTION;TOPICAL 021535-001 Jul 24, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 AB 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

Expired US Patents for CLOBEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp CLOBEX clobetasol propionate LOTION;TOPICAL 021535-001 Jul 24, 2003   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005   Start Trial   Start Trial
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004   Start Trial   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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