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

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Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Halobetasol propionate - Generic Drug Details

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

Halobetasol propionate is the generic ingredient in five branded drugs marketed by Mayne Pharma, Acp Nimble, Fougera Pharms, Perrigo Israel, Taro, Sun Pharm Inds Inc, Bausch, Sun Pharm Industries, and Teligent Pharma Inc, and is included in sixteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate has seventy-one patent family members in twenty-eight countries.

There are nine drug master file entries for halobetasol propionate. Eleven suppliers are listed for this compound.

Drug Prices for halobetasol propionate

See drug prices for halobetasol propionate

Recent Clinical Trials for halobetasol propionate

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

SponsorPhase
Mayne Pharma International Pty LtdPhase 4
Bausch Health Americas, Inc.Phase 4
Novum Pharmaceutical Research ServicesPhase 2

See all halobetasol propionate clinical trials

Recent Litigation for halobetasol propionate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Sun Pharmaceutical Industries, Inc. v. Perrigo Company2018-05-10
Sun Pharmaceutical Industries, Inc. v. Perrigo Company2018-05-09
HOLLANDER v. RANBAXY LABORATORIES INC.2010-02-23

See all halobetasol propionate litigation

Pharmacology for halobetasol propionate
Synonyms for halobetasol propionate
(1R,8S,13S,14R)-14-(2-chloroacetyl)-1,8-difluoro-17-hydroxy-2,13,15-trimethyl-5-oxotetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-14-yl propanoate
(6|A,11|A,16|A)-21-Chloro-6,9-difluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione
(6|A,11|A,16|A)-21-Chloro-6,9-difluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione; Miracorten; Ulobetasol propionate; Ultravate
(6S,8S,9R,10S,11S,13S,14S,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl propionate
[(6S,8S,9R,10S,11S,13S,14S,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
[(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
[17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
21-Chloro-6alpha,9-difluoro-11beta,17-dihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-propionate
6 alpha-fluoroclobetasol 17-propionate
6-fluoroclobetasol 17-propionate
66852-54-8
852H548
91A0K1TY3Z
AB01566925_01
AB2000750
AC1L2JJ6
AC1NBUQD
AC1OCF43
AKOS025310143
AN-14228
API0002882
AS-14150
BDSYKGHYMJNPAB-LICBFIPMSA-N
BMY 30056
BMY-30056
BRD-K65877271-001-01-8
C25H31ClF2O5
CAS-66852-54-8
CGP 14 458
CGP 14458
CGP-14,458
CGP-14458
CHEBI:135782
CHEMBL1200908
CHEMBL1876307
CS-4305
CTK8G0126
D04409
DSSTox_CID_26636
DSSTox_GSID_46636
DSSTox_RID_81782
DTXSID6046636
FT-0630768
Halobetasol (propionate)
Halobetasol propionate (USAN)
Halobetasol propionate [USAN:USP]
Halobetasol propionate [USAN]
Halobetasol(propionate)
Halobetasolpropionate
HY-B0878
K097
KS-00001F9L
LS-118431
Miracorten
MolPort-006-167-587
MolPort-023-278-129
NCGC00167451-01
NCGC00373230-02
Pregna-1,4-diene-3,20-dione, 21-chloro-6,9-difluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (6alpha,11beta,16beta)-
Pregna-1,4-diene-3,20-dione, 21-chloro-6,9-difluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-,(6-alpha,11-beta,16-beta)-
s4089
SC-18329
SCHEMBL1650038
SCHEMBL33858
SR-01000942239
SR-01000942239-1
SW219967-1
Tox21_112455
Ulobetasol (Halobetasol)Propionate
Ulobetasol cream
Ulobetasol propionate
Ultravate
Ultravate (TN)
UNII-91A0K1TY3Z
ZINC35570380
ZINC3920028
Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE
Tradename Dosage Ingredient NDA Submissiondate
BRYHALI LOTION;TOPICAL halobetasol propionate 209355 2019-05-15
ULTRAVATE LOTION;TOPICAL halobetasol propionate 208183 2018-01-24

US Patents and Regulatory Information for halobetasol propionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ULTRAVATE halobetasol propionate CREAM;TOPICAL 019967-001 Dec 27, 1990 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ULTRAVATE halobetasol propionate LOTION;TOPICAL 208183-001 Nov 6, 2015 RX Yes Yes   Start Trial   Start Trial Y   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 halobetasol propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Inc ULTRAVATE halobetasol propionate CREAM;TOPICAL 019967-001 Dec 27, 1990   Start Trial   Start Trial
Sun Pharm Inds Inc ULTRAVATE halobetasol propionate OINTMENT;TOPICAL 019968-001 Dec 17, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for halobetasol propionate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 474 Finland   Start Trial
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania   Start Trial PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992 122013000081 Germany   Start Trial PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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