ulobetasol propionate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| prednisone and prednisolone derivatives | 1349 | 66852-54-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
used in ointment to treat psoriasis; Ulobetasol cream contains 0.05% 6-fluoroclobetasol 17-propionate
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 17, 1990 | FDA | RANBAXY |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Psoriasis | 133.51 | 28.64 | 51 | 1006 | 68949 | 50535118 |
| Product dose omission issue | 33.78 | 28.64 | 29 | 1028 | 183809 | 50420258 |
| Psoriatic arthropathy | 29.74 | 28.64 | 16 | 1041 | 47016 | 50557051 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Psoriasis | 120.02 | 34.22 | 36 | 421 | 32191 | 29541879 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Psoriasis | 176.27 | 27.10 | 62 | 1190 | 71641 | 64425839 |
| Psoriatic arthropathy | 35.07 | 27.10 | 17 | 1235 | 43264 | 64454216 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.48 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 |
| 0.05% | 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | April 25, 2022 | NEW PRODUCT |
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Glucocorticoid receptor | Nuclear hormone receptor | AGONIST | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019575 | VUID |
| N0000147674 | NUI |
| D04409 | KEGG_DRUG |
| 4019575 | VANDF |
| 4019773 | VANDF |
| CHEBI:135782 | CHEBI |
| CHEMBL1200908 | ChEMBL_ID |
| C064466 | MESH_SUPPLEMENTAL_RECORD_UI |
| 91A0K1TY3Z | UNII |
| 6918178 | PUBCHEM_CID |
| 5311167 | 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 |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |
| 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 | 0713-0758 | 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 |
| 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 | 63629-8665 | 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 |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8735 | CREAM | 0.50 mg | TOPICAL | ANDA | 19 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8735 | CREAM | 0.50 mg | TOPICAL | ANDA | 19 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63739-998 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70512-033 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 11 sections |
| Halobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70752-119 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |