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Last Updated: February 26, 2020

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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 six 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. Ten 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
Sun Pharmaceutical Industries LimitedPhase 2

See all halobetasol propionate clinical trials

Recent Litigation for halobetasol propionate

Identify potential future generic entrants

District Court Litigation
Case NameDate
BAUSCH HEALTH IRELAND LIMITED v. GLENMARK PHARMACEUTICALS LIMITED2019-06-28
Sun Pharmaceutical Industries, Inc. v. Perrigo Company2018-05-10
Sun Pharmaceutical Industries, Inc. v. Perrigo Company2018-05-09

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
Perrigo Israel HALOBETASOL PROPIONATE halobetasol propionate CREAM;TOPICAL 077123-001 Dec 16, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Acp Nimble HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 077109-001 Jun 14, 2005 AB RX No 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
Taro HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 076994-001 Dec 16, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Teligent Pharma Inc HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 209978-001 Mar 20, 2018 AB 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 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 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 SPC/GB13/061 United Kingdom   Start Trial PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 2013C/060 Belgium   Start Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
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
1304992 C300617 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992 132013902214376 Italy   Start Trial PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
McKinsey
Colorcon
Moodys
AstraZeneca

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