Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 21, 2019

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CLOBETASOL PROPIONATE - Generic Drug Details

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What are the generic drug sources for clobetasol propionate and what is the scope of patent protection?

Clobetasol propionate is the generic ingredient in eleven branded drugs marketed by Glenmark Pharms Ltd, Ingenus Pharms Llc, Perrigo Israel, Perrigo Uk Finco, Taro, Mylan, Acp Nimble, Amneal Pharms Llc, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Solaris Pharma Corp, Teligent Pharma Inc, Teva Pharms Usa, Xiromed, Zydus Pharms, Fougera Pharms, Novast Labs, Hi Tech Pharma, Encore Dermat, Perrigo Co, Actavis Mid Atlantic, Hi Tech, Galderma Labs Lp, Aleor Dermaceuticals, Novel Labs Inc, Galderma Labs, Macleods Pharms Ltd, Tolmar, Wockhardt Bio Ag, Akorn, Apotex Inc, and Paddock Llc, and is included in seventy-eight NDAs. There are eleven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clobetasol propionate has one hundred patent family members in twenty-seven countries.

There are fourteen drug master file entries for clobetasol propionate. Forty-seven suppliers are listed for this compound.

Drug Prices for CLOBETASOL PROPIONATE

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Drug Sales Revenue Trends for CLOBETASOL PROPIONATE

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Recent Clinical Trials for CLOBETASOL PROPIONATE

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SponsorPhase
Association pour la Recherche Clinique et ImmunologiqueN/A
Beni-Suef UniversityPhase 1
DermtreatPhase 2

See all CLOBETASOL PROPIONATE clinical trials

Recent Litigation for CLOBETASOL PROPIONATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories LP v. Akorn Inc2016-04-14
Delcor Asset Corporation v. Taro Pharmaceutical Industries, Ltd.2016-03-01
Galderma Laboratories LP v. Teligent Inc2015-12-04

See all CLOBETASOL PROPIONATE litigation

Pharmacology for CLOBETASOL PROPIONATE
Medical Subject Heading (MeSH) Categories for CLOBETASOL PROPIONATE
Synonyms for CLOBETASOL PROPIONATE
(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 (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
Clobex
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

US Patents and Regulatory Information for CLOBETASOL PROPIONATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 206075-001 Nov 23, 2015 AT RX No No   Start Trial   Start Trial   Start Trial
Taro CLOBETASOL PROPIONATE clobetasol propionate SOLUTION;TOPICAL 075363-001 Dec 29, 2000 AT RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd CLOBETASOL PROPIONATE clobetasol propionate SPRAY;TOPICAL 208125-001 Mar 26, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Akorn CLOBETASOL PROPIONATE clobetasol propionate SPRAY;TOPICAL 207218-001 Apr 28, 2017 AT 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 CLOBETASOL PROPIONATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005   Start Trial   Start Trial
Mylan OLUX clobetasol propionate AEROSOL, FOAM;TOPICAL 021142-001 May 26, 2000   Start Trial   Start Trial
Fougera Pharms TEMOVATE clobetasol propionate CREAM;TOPICAL 019322-001 Dec 27, 1985   Start Trial   Start Trial
Fougera Pharms TEMOVATE clobetasol propionate SOLUTION;TOPICAL 019966-001 Feb 22, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.