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

Stem definition	Drug id	CAS RN
arotinoid derivatives	2571	118292-40-3

Description:

Molecule	Description
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

Molecule

Description

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:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	2.17	Basic

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
0.1%	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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.1%	TAZAROTENE	COSETTE	A214136	Sept. 13, 2022	RX	GEL	TOPICAL	March 13, 2023	COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Retinoic acid receptor alpha	Nuclear hormone receptor	P10276	RARA_HUMAN	AGONIST	EC50	7.20	CHEMBL	CHEMBL
Retinoic acid receptor beta	Nuclear hormone receptor	P10826	RARB_HUMAN	AGONIST	EC50	9.10	CHEMBL	CHEMBL
Retinoic acid receptor gamma	Nuclear hormone receptor	P13631	RARG_HUMAN	AGONIST	EC50	7.40	CHEMBL	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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