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

Stem definition	Drug id	CAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives	1813	10118-90-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: minocycline minocycline hydrochloride minocycline HCl	A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections. Molecular weight: 457.48 Formula: C23H27N3O7 CLOGP: 0.05 LIPINSKI: 0 HAC: 10 HDO: 5 TPSA: 164.63 ALOGS: -2.17 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

minocycline
minocycline hydrochloride
minocycline HCl

A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.

Molecular weight: 457.48
Formula: C23H27N3O7
CLOGP: 0.05
LIPINSKI: 0
HAC: 10
HDO: 5
TPSA: 164.63
ALOGS: -2.17
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	mg	O
0.20	g	O
0.20	g	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	97 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.87 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	17 hours	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	11 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	1.60 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
June 30, 1971	FDA	TRIAX PHARMS

FDA Adverse Event Reporting System (Female)

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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
Exostosis	454.22	15.69	195	25664	17667	63445496
Bone erosion	452.45	15.69	194	25665	17523	63445640
Joint dislocation	441.38	15.69	194	25665	18606	63444557
Foot deformity	368.78	15.69	194	25665	27659	63435504
Polyarteritis nodosa	332.57	15.69	63	25796	228	63462935
Lupus-like syndrome	317.98	15.69	145	25714	15150	63448013
Joint stiffness	307.63	15.69	199	25660	41670	63421493
Retinitis	292.93	15.69	106	25753	6090	63457073
Osteoporosis	277.47	15.69	211	25648	57127	63406036
Hepatic cirrhosis	273.70	15.69	153	25706	24581	63438582

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FDA Adverse Event Reporting System (Male)

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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
Apparent death	228.41	20.25	70	9555	3574	34943732
Photosensitivity reaction	218.51	20.25	89	9536	10505	34936801
Red blood cell sedimentation rate increased	202.84	20.25	81	9544	9081	34938225
Terminal state	202.44	20.25	65	9560	3869	34943437
C-reactive protein abnormal	189.34	20.25	76	9549	8634	34938672
Interstitial lung disease	189.28	20.25	151	9474	65131	34882175
Skin hyperpigmentation	184.77	20.25	58	9567	3206	34944100
Pulmonary thrombosis	183.34	20.25	71	9554	7336	34939970
Stomatitis	181.03	20.25	124	9501	42390	34904916
Intestinal sepsis	143.56	20.25	34	9591	637	34946669

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FDA Adverse Event Reporting System (Geriatric)

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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
Polyarteritis nodosa	415.13	14.80	83	30088	462	79713755
Exostosis	296.01	14.80	139	30032	16719	79697498
Joint dislocation	295.38	14.80	139	30032	16800	79697417
Lupus-like syndrome	292.89	14.80	130	30041	13727	79700490
Bone erosion	288.46	14.80	139	30032	17708	79696509
Skin hyperpigmentation	287.19	14.80	107	30064	7196	79707021
Red blood cell sedimentation rate increased	263.27	14.80	182	29989	45760	79668457
Retinitis	252.73	14.80	91	30080	5552	79708665
Foot deformity	251.94	14.80	140	30031	23934	79690283
Drug intolerance	224.79	14.80	377	29794	263742	79450475

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A01AB23	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Antiinfectives and antiseptics for local oral treatment
ATC	D10AF07	DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Antiinfectives for treatment of acne
ATC	J01AA08	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE TETRACYCLINES Tetracyclines
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:76971	Escherichia coli metabolites
CHEBI has role	CHEBI:176497	geroprotectors
FDA CS	M0021223	Tetracyclines
FDA EPC	N0000175882	Tetracycline-class Drug
FDA PE	N0000193995	Decreased Prothrombin Activity
MeSH PA	D000900	Anti-Bacterial Agents

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

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Disease	Relation	SNOMED_ID	DOID
Trachoma	indication	2576002	DOID:11265
Listeriosis	indication	4241002	DOID:11573
Actinomycotic infection	indication	11817007	DOID:8478
Gonorrhea	indication	15628003	DOID:7551
Tularemia	indication	19265001
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Gingivostomatitis	indication	20607006
Acute gonococcal cervicitis	indication	20943002	DOID:10615
Granuloma inguinale	indication	28867007	DOID:9113
Acute gonococcal urethritis	indication	29864006

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.13	acidic
pKa2	8.85	acidic
pKa3	11.14	acidic
pKa4	11.96	acidic
pKa5	13.08	acidic
pKa6	9.55	Basic
pKa7	4.82	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 1.5% BASE	ZILXI	JOURNEY	N213690	May 28, 2020	RX	AEROSOL, FOAM	TOPICAL	10213512	Oct. 1, 2030	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
EQ 1.5% BASE	ZILXI	JOURNEY	N213690	May 28, 2020	RX	AEROSOL, FOAM	TOPICAL	10322186	Oct. 1, 2030	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
EQ 1.5% BASE	ZILXI	JOURNEY	N213690	May 28, 2020	RX	AEROSOL, FOAM	TOPICAL	10946101	Oct. 1, 2030	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
EQ 1.5% BASE	ZILXI	JOURNEY	N213690	May 28, 2020	RX	AEROSOL, FOAM	TOPICAL	8865139	Oct. 1, 2030	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
EQ 1.5% BASE	ZILXI	JOURNEY	N213690	May 28, 2020	RX	AEROSOL, FOAM	TOPICAL	8992896	Oct. 1, 2030	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
EQ 1.5% BASE	ZILXI	JOURNEY	N213690	May 28, 2020	RX	AEROSOL, FOAM	TOPICAL	9675700	Oct. 1, 2030	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
EQ 100MG BASE/VIAL	MINOCIN	REMPEX	N050444	None	RX	INJECTABLE	INJECTION	9084802	May 12, 2031	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 100MG BASE/VIAL	MINOCIN	REMPEX	N050444	None	RX	INJECTABLE	INJECTION	9278105	May 12, 2031	METHOD OF TREATING BACTERIAL INFECTIONS
EQ 105MG BASE	SOLODYN	BAUSCH	N050808	Aug. 27, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	7790705	June 24, 2025	TREATMENT OF ACNE
EQ 105MG BASE	SOLODYN	BAUSCH	N050808	Aug. 27, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8252776	June 24, 2025	TREATMENT OF ACNE

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	UniProt	Type	Activity value (-log[M])	Bioact source
Tetracycline resistance protein, class B	Transporter	TCR2_ECOLX	IC50	5.64	WOMBAT-PK
30S ribosomal protein S4	Ribosomal protein	RS4_CHLPN	Ka	6	WOMBAT-PK
30S ribosomal protein S9	Ribosomal protein	RS9_CHLPN	Ka	5.76	WOMBAT-PK

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External reference:

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ID	Source
MIY	PDB_CHEM_ID
002754	NDDF
004864	NDDF
10831	IUPHAR_LIGAND_ID
1213	MMSL
13512003	SNOMEDCT_US
13614-98-7	SECONDARY_CAS_RN
1646	INN_ID
21389	MMSL
372653009	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
minocycline hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9935	TABLET, FILM COATED, EXTENDED RELEASE	65 mg	ORAL	NDA authorized generic	29 sections
minocycline hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9935	TABLET, FILM COATED, EXTENDED RELEASE	65 mg	ORAL	NDA authorized generic	29 sections
minocycline hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9936	TABLET, FILM COATED, EXTENDED RELEASE	115 mg	ORAL	NDA authorized generic	29 sections
minocycline hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-9936	TABLET, FILM COATED, EXTENDED RELEASE	115 mg	ORAL	NDA authorized generic	29 sections
Minocycline hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0440-7805	CAPSULE	100 mg	ORAL	ANDA	24 sections
Minocycline Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3153	CAPSULE	75 mg	ORAL	ANDA	26 sections
Minocycline Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-5694	CAPSULE	50 mg	ORAL	ANDA	26 sections
Minocycline Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-5695	CAPSULE	100 mg	ORAL	ANDA	26 sections
Minocycline Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5385	TABLET, EXTENDED RELEASE	45 mg	ORAL	ANDA	26 sections
Minocycline Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5386	TABLET, EXTENDED RELEASE	90 mg	ORAL	ANDA	26 sections

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