ulobetasol propionate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 1349 66852-54-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • halobetasol propionate
  • ulobetasol propionate
  • miracorten
used in ointment to treat psoriasis; Ulobetasol cream contains 0.05% 6-fluoroclobetasol 17-propionate
  • Molecular weight: 484.96
  • Formula: C25H31ClF2O5
  • CLOGP: 3.53
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 80.67
  • ALOGS: -4.81
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 17, 1990 FDA RANBAXY

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Psoriasis 145.23 29.56 59 1366 86898 63400699
Noninfective encephalitis 52.29 29.56 9 1416 435 63487162
Dermatitis atopic 44.54 29.56 14 1411 9710 63477887
Product use in unapproved indication 42.94 29.56 34 1391 179046 63308551
Suspected COVID-19 36.56 29.56 9 1416 2553 63485044
Product dose omission issue 35.01 29.56 34 1391 234279 63253318
Psoriatic arthropathy 34.77 29.56 23 1402 91497 63396100
Dry skin 33.69 29.56 19 1406 56868 63430729

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Psoriasis 133.62 37.88 44 690 38768 34917429
Drug ineffective 50.30 37.88 54 680 456697 34499500
Dermatitis atopic 39.63 37.88 11 723 5336 34950861

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Psoriasis 180.98 27.29 68 1562 89519 79653239
Dermatitis atopic 45.36 27.29 14 1616 10042 79732716
Noninfective encephalitis 43.60 27.29 8 1622 613 79742145
Dry skin 43.08 27.29 23 1607 67972 79674786
Suspected COVID-19 30.71 27.29 8 1622 3125 79739633
Psoriatic arthropathy 29.77 27.29 19 1611 77980 79664778

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D05AX55 DERMATOLOGICALS
ANTIPSORIATICS
ANTIPSORIATICS FOR TOPICAL USE
Other antipsoriatics for topical use
ATC D07AC21 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014662 Vasoconstrictor Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Lichen simplex chronicus indication 53891004
Granuloma annulare indication 65508009 DOID:3777
Pruritus ani indication 90446007
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Primary cutaneous T-cell lymphoma indication 400122007
Skin ulcer contraindication 46742003
Hypopituitarism contraindication 74728003 DOID:9406
Fissure in skin contraindication 95321009
Skin irritation contraindication 367466007
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Denuded skin contraindication 418242004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.48 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.01%;0.045% DUOBRII BAUSCH N209354 April 25, 2019 RX LOTION TOPICAL 10478502 Nov. 2, 2031 TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
0.01% BRYHALI BAUSCH N209355 Nov. 6, 2018 RX LOTION TOPICAL 10478502 Nov. 2, 2031 TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
0.05% ULTRAVATE SUN PHARM INDUSTRIES N208183 Nov. 6, 2015 RX LOTION TOPICAL 8962028 June 19, 2033 USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES INCLUDING PSORIASIS
0.01%;0.045% DUOBRII BAUSCH N209354 April 25, 2019 RX LOTION TOPICAL 10426787 June 6, 2036 TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
0.01%;0.045% DUOBRII BAUSCH N209354 April 25, 2019 RX LOTION TOPICAL 11648256 June 6, 2036 TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
0.01%;0.045% DUOBRII BAUSCH N209354 April 25, 2019 RX LOTION TOPICAL 11679115 June 6, 2036 TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
0.05% LEXETTE MAYNE PHARMA N210566 May 24, 2018 RX AEROSOL, FOAM TOPICAL 11020407 Nov. 30, 2036 FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.05% ULTRAVATE SUN PHARM INDUSTRIES N208183 Nov. 6, 2015 RX LOTION TOPICAL Aug. 31, 2023 NEW PATIENT POPULATION
0.05% LEXETTE MAYNE PHARMA N210566 May 24, 2018 RX AEROSOL, FOAM TOPICAL Aug. 18, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL

External reference:

IDSource
4019575 VUID
N0000147674 NUI
D04409 KEGG_DRUG
4019575 VANDF
4019773 VANDF
CHEBI:135782 CHEBI
CHEMBL1200908 ChEMBL_ID
C064466 MESH_SUPPLEMENTAL_RECORD_UI
6918178 PUBCHEM_CID
DB00596 DRUGBANK_ID
41208 RXNORM
4815 MMSL
63970 MMSL
003564 NDDF
003565 NDDF
126085005 SNOMEDCT_US
764616008 SNOMEDCT_US
764617004 SNOMEDCT_US
C0098735 UMLSCUI
C0082787 UMLSCUI
5311167 PUBCHEM_CID
91A0K1TY3Z UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0355 CREAM 0.50 mg TOPICAL ANDA 19 sections
Bryhali HUMAN PRESCRIPTION DRUG LABEL 1 0187-0002 LOTION 0.10 mg TOPICAL NDA 24 sections
Duobrii HUMAN PRESCRIPTION DRUG LABEL 2 0187-0653 LOTION 0.10 mg TOPICAL NDA 25 sections
Duobrii HUMAN PRESCRIPTION DRUG LABEL 2 0187-0653 LOTION 0.10 mg TOPICAL NDA 25 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0339 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0640 CREAM 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0640 CREAM 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0758 CREAM 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0758 CREAM 0.50 mg TOPICAL ANDA 21 sections
Ultravate HUMAN PRESCRIPTION DRUG LABEL 1 10631-122 LOTION 0.50 mg TOPICAL NDA 26 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 42254-250 CREAM 0.50 mg TOPICAL ANDA 22 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 45802-129 CREAM 0.50 mg TOPICAL ANDA 22 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 45802-131 OINTMENT 0.50 mg TOPICAL ANDA 22 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 51672-1321 CREAM 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 51672-1322 OINTMENT 0.50 mg TOPICAL ANDA 22 sections
LEXETTE HUMAN PRESCRIPTION DRUG LABEL 1 51862-604 AEROSOL, FOAM 0.50 mg TOPICAL NDA 29 sections
LEXETTE HUMAN PRESCRIPTION DRUG LABEL 1 51862-604 AEROSOL, FOAM 0.50 mg TOPICAL NDA 29 sections
LEXETTE HUMAN PRESCRIPTION DRUG LABEL 1 51862-604 AEROSOL, FOAM 0.50 mg TOPICAL NDA 29 sections
Halobetasol propionate HUMAN PRESCRIPTION DRUG LABEL 1 51862-606 AEROSOL, FOAM 0.50 mg TOPICAL NDA 30 sections
Halobetasol propionate HUMAN PRESCRIPTION DRUG LABEL 1 51862-606 AEROSOL, FOAM 0.50 mg TOPICAL NDA 30 sections
Halobetasol propionate HUMAN PRESCRIPTION DRUG LABEL 1 51862-606 AEROSOL, FOAM 0.50 mg TOPICAL NDA 30 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 52565-073 OINTMENT 0.50 mg TOPICAL ANDA 20 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 52959-961 OINTMENT 0.50 mg TOPICAL ANDA 22 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 54868-4907 CREAM 0.50 mg TOPICAL ANDA 20 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 54868-5482 OINTMENT 0.50 mg TOPICAL ANDA 20 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8664 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8664 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8664 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8665 OINTMENT 0.50 mg TOPICAL ANDA 21 sections
Halobetasol Propionate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8665 OINTMENT 0.50 mg TOPICAL ANDA 21 sections