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AboutPricing
Drug ReportsHalobetasol
Halobetasol
Bryhali, Duobrii, Halobetasol, Lexette (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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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, Halobetasol, Lexette, Ultravate (discontinued: Halobetasol, Ultravate)
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
halobetasol propionateANDA2024-10-24
lexetteNew Drug Application2023-08-10
ultravateNew Drug Application2020-09-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pruritusHP_0000989D011537L29
inflammationMP_0001845D007249—
facial dermatoses—D005148—
foot dermatoses—D005533—
hand dermatoses—D006229—
scalp dermatoses—D012536—
leg dermatoses—D007868—
psoriasisEFO_0000676D011565L40
acne vulgarisEFO_0003894D000152L70
Agency Specific
FDA
EMA
Expiration
Code
HALOBETASOL PROPIONATE, LEXETTE, MAYNE PHARMA
2024-08-18NPP
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE, PADAGIS ISRAEL
2024-06-24PC
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
116482562036-06-06DPU-2625
116791152036-06-06DPU-2625
Halobetasol Propionate, Ultravate, Sun Pharm Industries
89620282033-06-19DPU-1775
Halobetasol Propionate, Bryhali, Bausch
88093072031-11-02DP
104785022031-11-02DPU-2625
118396562031-11-02U-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
Clinical Trials
37 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L4049710230
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acne keloidD000153—L73.0——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L20—1———1
EczemaD004485HP_0000964L30.9—1———1
DermatitisD003872HP_0011123L30.9—1———1
HemorrhoidsD006484EFO_0009552K64—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2———24
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHalobetasol
INNulobetasol
Description
Halobetasol is a corticosteroid hormone.
Classification
Small molecule
Drug class—
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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
RxCUI—
ChEMBL IDCHEMBL1201360
ChEBI ID—
PubChem CID5311167
DrugBankDB00596
UNII ID9P6159HM7T (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Halobetasol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 325 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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497 adverse events reported
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