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

Stem definitionDrug idCAS RN
arotinoid derivatives 2571 118292-40-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tazarotene
  • tazorac
  • fabior
  • AGN-190168
a topical acetylenic retinoid; a topical kerytolytic
  • Molecular weight: 351.46
  • Formula: C21H21NO2S
  • CLOGP: 6.08
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 0
  • TPSA: 39.19
  • ALOGS: -5.67
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 3.55 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 37.20 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.22 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 13, 1997 FDA ALLERGAN

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D05AX05 DERMATOLOGICALS
ANTIPSORIATICS
ANTIPSORIATICS FOR TOPICAL USE
Other antipsoriatics for topical use
ATC D05AX55 DERMATOLOGICALS
ANTIPSORIATICS
ANTIPSORIATICS FOR TOPICAL USE
Other antipsoriatics for topical use
FDA CS M0018962 Retinoids
MeSH PA D003879 Dermatologic Agents
MeSH PA D007641 Keratolytic Agents
MeSH PA D009676 Noxae
MeSH PA D013723 Teratogens
FDA EPC N0000175607 Retinoid
CHEBI has role CHEBI:50176 keratolytic drugs
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50905 teratogeno

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

DiseaseRelationSNOMED_IDDOID
Psoriasis indication 9014002 DOID:8893
Acne vulgaris indication 88616000
Facial Hyperpigmentation indication
Benign Facial Lentigine indication
Facial Fine Wrinkling indication
Facial Hypopigmentation indication
Sunburn contraindication 23346002
Photosensitivity contraindication 90128006
Pregnancy, function contraindication 289908002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.17 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.1% FABIOR MAYNE PHARMA N202428 May 11, 2012 RX AEROSOL, FOAM TOPICAL 10568859 Feb. 24, 2030 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER
0.1% FABIOR MAYNE PHARMA N202428 May 11, 2012 RX AEROSOL, FOAM TOPICAL 10688071 Feb. 24, 2030 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER
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%;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
0.045% ARAZLO BAUSCH N211882 Dec. 18, 2019 RX LOTION TOPICAL 11311482 May 11, 2038 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.1% TAZAROTENE COSETTE A214136 Sept. 13, 2022 RX GEL TOPICAL March 13, 2023 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Retinoic acid receptor alpha Nuclear hormone receptor AGONIST EC50 7.20 CHEMBL CHEMBL
Retinoic acid receptor beta Nuclear hormone receptor AGONIST EC50 9.10 CHEMBL CHEMBL
Retinoic acid receptor gamma Nuclear hormone receptor AGONIST EC50 7.40 CHEMBL CHEMBL

External reference:

IDSource
4021045 VUID
N0000148509 NUI
D01132 KEGG_DRUG
4021045 VANDF
C0288792 UMLSCUI
CHEBI:32184 CHEBI
CHEMBL1657 ChEMBL_ID
DB00799 DRUGBANK_ID
C086827 MESH_SUPPLEMENTAL_RECORD_UI
5381 PUBCHEM_CID
6952 IUPHAR_LIGAND_ID
7328 INN_ID
81BDR9Y8PS UNII
1293452 RXNORM
10196 MMSL
190198 MMSL
255259 MMSL
5542 MMSL
006668 NDDF
108906007 SNOMEDCT_US
386935009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-0042 GEL 1 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-8335 GEL 0.50 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-9155 CREAM 0.50 mg CUTANEOUS NDA 26 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-9156 CREAM 1 mg CUTANEOUS NDA 26 sections
TAZAROTENE HUMAN PRESCRIPTION DRUG LABEL 1 0168-0454 CREAM 1 mg TOPICAL ANDA 26 sections
Tazarotene Cream HUMAN PRESCRIPTION DRUG LABEL 1 0168-0455 CREAM 1 mg TOPICAL ANDA 25 sections
Duobrii HUMAN PRESCRIPTION DRUG LABEL 2 0187-0653 LOTION 0.45 mg TOPICAL NDA 25 sections
Duobrii HUMAN PRESCRIPTION DRUG LABEL 2 0187-0653 LOTION 0.45 mg TOPICAL NDA 25 sections
Arazlo HUMAN PRESCRIPTION DRUG LABEL 1 0187-2098 LOTION 0.45 mg TOPICAL NDA 24 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 0713-0670 CREAM 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 0713-0670 CREAM 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 0713-0764 CREAM 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 0713-0764 CREAM 1 mg TOPICAL ANDA 27 sections
TAZAROTENE HUMAN PRESCRIPTION DRUG LABEL 1 0713-0804 GEL 1 mg TOPICAL ANDA 18 sections
TAZAROTENE HUMAN PRESCRIPTION DRUG LABEL 1 0713-0805 GEL 0.50 mg TOPICAL ANDA 18 sections
Tazorac HUMAN PRESCRIPTION DRUG LABEL 1 16110-042 GEL 1 mg CUTANEOUS NDA 29 sections
Tazorac HUMAN PRESCRIPTION DRUG LABEL 1 16110-833 GEL 0.50 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 16110-915 CREAM 0.05 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 16110-915 CREAM 0.05 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 16110-916 CREAM 0.10 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 16110-916 CREAM 0.10 mg CUTANEOUS NDA 29 sections
TAZAROTENE HUMAN PRESCRIPTION DRUG LABEL 1 45802-436 GEL 0.50 mg TOPICAL ANDA 27 sections
TAZAROTENE HUMAN PRESCRIPTION DRUG LABEL 1 45802-442 GEL 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 51672-1373 CREAM 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 51672-1373 CREAM 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 51672-1374 CREAM 1 mg TOPICAL ANDA 27 sections
FABIOR HUMAN PRESCRIPTION DRUG LABEL 1 51862-295 AEROSOL, FOAM 1 mg TOPICAL NDA 27 sections
FABIOR HUMAN PRESCRIPTION DRUG LABEL 1 51862-295 AEROSOL, FOAM 1 mg TOPICAL NDA 27 sections
Tazorac HUMAN PRESCRIPTION DRUG LABEL 1 54868-4456 GEL 1 mg ORAL NDA 14 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 60758-556 CREAM 0.50 mg TOPICAL NDA 28 sections