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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Bryhali, Halobetasol, Lexette, Ultravate (discontinued: Halobetasol, Ultravate)
CombinationsDuobrii, Halobetasol tazarotene
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 |
|---|---|---|---|---|
| BRYHALI | Bausch Health Companies | N-209355 RX | 2018-11-06 | 1 products, RLD, RS |
| LEXETTE | Mayne Group | N-210566 RX | 2018-05-24 | 1 products, RLD, RS |
| ULTRAVATE | Sun Pharmaceutical Industries | N-208183 RX | 2015-11-06 | 1 products, RLD, RS |
Show 2 discontinued
Halobetasol propionate
+
Tazarotene
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUOBRII | Bausch Health Companies | N-209354 RX | 2019-04-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bryhali | New Drug Application | 2020-06-01 |
| duobrii | New Drug Application | 2020-01-01 |
| halobetasol propionate | ANDA | 2024-10-24 |
| lexette | ANDA | 2025-05-31 |
| ultravate | New Drug Application | 2025-04-06 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
HALOBETASOL PROPIONATE, LEXETTE, MAYNE PHARMA | |||
| 2024-08-18 | NPP | ||
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE, PADAGIS ISRAEL | |||
| 2024-06-24 | PC | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Halobetasol Propionate, Lexette, Mayne Pharma | |||
| 10857159 | 2036-11-30 | DP | |
| 11020407 | 2036-11-30 | DP | U-3143 |
| Halobetasol Propionate / Tazarotene, Duobrii, Bausch | |||
| 10251895 | 2036-06-06 | DP | |
| 10426787 | 2036-06-06 | U-2625 | |
| 11648256 | 2036-06-06 | DP | U-2625 |
| 11679115 | 2036-06-06 | DP | U-2625 |
| Halobetasol Propionate, Ultravate, Sun Pharm Industries | |||
| 8962028 | 2033-06-19 | DP | U-1775 |
| Halobetasol Propionate, Bryhali, Bausch | |||
| 8809307 | 2031-11-02 | DP | |
| 10478502 | 2031-11-02 | DP | U-2625 |
| 11839656 | 2031-11-02 | U-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
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Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Halobetasol |
| INN | ulobetasol |
| Description | Halobetasol is a corticosteroid hormone. |
| 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-ID | 98651-66-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201360 |
| ChEBI ID | — |
| PubChem CID | 5311167 |
| DrugBank | DB00596 |
| UNII ID | 9P6159HM7T (ChemIDplus, GSRS) |
Target
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Variants
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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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Trends
PubMed Central
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Additional graphs summarizing 367 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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523 adverse events reported
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