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Halobetasol
Bryhali, Duobrii, Lexette, Ultravate (halobetasol) is a small molecule pharmaceutical. Halobetasol was first approved as Ultravate on 1990-12-17. It is used to treat facial dermatoses, foot dermatoses, hand dermatoses, inflammation, and leg dermatoses amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Bryhali, Lexette, Ultravate (generic drugs available since 2004-12-16)
Combinations
Duobrii
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Halobetasol propionate
Tradename
Company
Number
Date
Products
BRYHALIBausch Health CompaniesN-209355 RX2018-11-06
1 products, RLD, RS
LEXETTEMayne GroupN-210566 RX2018-05-24
1 products, RLD, RS
ULTRAVATESun Pharmaceutical IndustriesN-208183 RX2015-11-06
1 products, RLD, RS
Show 2 discontinued
Halobetasol propionate
+
Tazarotene
Tradename
Company
Number
Date
Products
DUOBRIIBausch Health CompaniesN-209354 RX2019-04-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bryhaliNew Drug Application2020-06-01
duobriiNew Drug Application2020-01-01
lexetteNew Drug Application2020-06-30
ultravateNew Drug Application2020-09-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
facial dermatoses—D005148—
foot dermatoses—D005533—
hand dermatoses—D006229—
inflammationMP_0001845D007249—
leg dermatoses—D007868—
pruritusHP_0000989D011537L29
scalp dermatoses—D012536—
Agency Specific
FDA
EMA
Expiration
Code
HALOBETASOL PROPIONATE, LEXETTE, MAYNE PHARMA
2024-08-18NPP
HALOBETASOL PROPIONATE, ULTRAVATE, SUN PHARM INDUSTRIES
2023-08-31NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Halobetasol Propionate, Lexette, Mayne Pharma
108571592036-11-30DP
110204072036-11-30DPU-3143
Halobetasol Propionate / Tazarotene, Duobrii, Bausch
102518952036-06-06DP
104267872036-06-06U-2625
Halobetasol Propionate, Ultravate, Sun Pharm Industries
89620282033-06-19DPU-1775
Halobetasol Propionate, Bryhali, Bausch
88093072031-11-02DP
104785022031-11-02DPU-2625
ATC Codes
D: Dermatologicals
— D05: Antipsoriatics
— D05A: Antipsoriatics for topical use
— D05AX: Other antipsoriatics for topical use in atc
— D05AX55: Tazarotene and ulobetasol
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AC: Corticosteroids, potent (group iii)
— D07AC21: Ulobetasol
HCPCS
No data
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHALOBETASOL
INNulobetasol
Description
Ulobetasol (INN) or halobetasol (USAN) is a corticosteroid used to treat psoriasis. It is a class I corticosteroid under the US classification and a group III corticosteroid under international classification, the most potent group of such drugs.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@H]1C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)CCl
Identifiers
PDB—
CAS-ID98651-66-2
RxCUI41208
ChEMBL IDCHEMBL1201360
ChEBI ID—
PubChem CID5311167
DrugBankDB00596
UNII ID9P6159HM7T (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 256 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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37 adverse events reported
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