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

Stem definition	Drug id	CAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives	5299	389139-89-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: omadacycline omadacycline tosylate nuzyra PTK 0796 amadacycline BAY 73-6944 BAY 73-7388 MK-2764 neopentyl aminomethylminocycline ZL 2401	Omadacycline is an aminomethylcycline antibacterial within the tetracycline class of antibacterial drugs. Omadacycline binds to the 30S ribosomal subunit and blocks protein synthesis. Omadacycline is active in vitro against Gram positive bacteria expressing tetracycline resistance active efflux pumps (tetK and tet L) and ribosomal protection proteins (tet M). In general, omadacycline is considered bacteriostatic; however, omadacycline has demonstrated bactericidal activity against some isolates of S. pneumoniae and H. influenzae. Molecular weight: 556.66 Formula: C29H40N4O7 CLOGP: 1.22 LIPINSKI: 3 HAC: 11 HDO: 6 TPSA: 176.66 ALOGS: -3.42 ROTB: 7 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

omadacycline
omadacycline tosylate
nuzyra
PTK 0796
amadacycline
BAY 73-6944
BAY 73-7388
MK-2764
neopentyl aminomethylminocycline
ZL 2401

Omadacycline is an aminomethylcycline antibacterial within the tetracycline class of antibacterial drugs. Omadacycline binds to the 30S ribosomal subunit and blocks protein synthesis. Omadacycline is active in vitro against Gram positive bacteria expressing tetracycline resistance active efflux pumps (tetK and tet L) and ribosomal protection proteins (tet M). In general, omadacycline is considered bacteriostatic; however, omadacycline has demonstrated bactericidal activity against some isolates of S. pneumoniae and H. influenzae.

Molecular weight: 556.66
Formula: C29H40N4O7
CLOGP: 1.22
LIPINSKI: 3
HAC: 11
HDO: 6
TPSA: 176.66
ALOGS: -3.42
ROTB: 7

Status: ONP

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

Drug dosage:

Dose	Unit	Route
0.30	g	O
0.10	g	P

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
Vd (Volume of distribution)	2.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.34 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	15 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	100 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Oct. 2, 2018	FDA	PARATEK PHARMS INC

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
Off label use	46.80	44.27	29	201	674433	62814359

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FDA Adverse Event Reporting System (Male)

None

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
Off label use	49.58	38.81	33	242	907182	78836931

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J01AA15	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE TETRACYCLINES Tetracyclines
FDA CS	M0021223	Tetracyclines
FDA EPC	N0000175938	Tetracycline-class Antibacterial

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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
Bacterial pneumonia	indication	53084003	DOID:874
Bacterial infection of skin	indication	128936008

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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	6.89	acidic
pKa3	11.34	acidic
pKa4	11.96	acidic
pKa5	13.08	acidic
pKa6	10.7	Basic
pKa7	9.41	Basic
pKa8	5.81	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 100MG BASE/VIAL	NUZYRA	PARATEK PHARMS INC	N209817	Oct. 2, 2018	RX	POWDER	INTRAVENOUS	10124014	March 5, 2029	TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION
EQ 100MG BASE/VIAL	NUZYRA	PARATEK PHARMS INC	N209817	Oct. 2, 2018	RX	POWDER	INTRAVENOUS	9724358	March 5, 2029	TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
EQ 100MG BASE/VIAL	NUZYRA	PARATEK PHARMS INC	N209817	Oct. 2, 2018	RX	POWDER	INTRAVENOUS	10383884	Oct. 31, 2037	TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
EQ 100MG BASE/VIAL	NUZYRA	PARATEK PHARMS INC	N209817	Oct. 2, 2018	RX	POWDER	INTRAVENOUS	10835542	Oct. 31, 2037	TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	10124014	March 5, 2029	TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	9265740	March 5, 2029	TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	9724358	March 5, 2029	TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	10111890	Aug. 3, 2037	TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	10383884	Oct. 31, 2037	TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	10835542	Oct. 31, 2037	TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 100MG BASE/VIAL	NUZYRA	PARATEK PHARMS INC	N209817	Oct. 2, 2018	RX	POWDER	INTRAVENOUS	Oct. 2, 2023	NEW CHEMICAL ENTITY
EQ 100MG BASE/VIAL	NUZYRA	PARATEK PHARMS INC	N209817	Oct. 2, 2018	RX	POWDER	INTRAVENOUS	Oct. 2, 2028	GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	Oct. 2, 2023	NEW CHEMICAL ENTITY
EQ 150MG BASE	NUZYRA	PARATEK PHARMS INC	N209816	Oct. 2, 2018	RX	TABLET	ORAL	Oct. 2, 2028	GENERATING ANTIBIOTIC INCENTIVES NOW

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Bioactivity Summary:

None

External reference:

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ID	Source
U3B	PDB_CHEM_ID
017788	NDDF
017789	NDDF
090IP5RV8F	UNII
1075240-43-5	SECONDARY_CAS_RN
10839	IUPHAR_LIGAND_ID
2059268	RXNORM
294191	MMSL
35300	MMSL
4038061	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
NUZYRA	HUMAN PRESCRIPTION DRUG LABEL	1	71715-001	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	33 sections
NUZYRA	HUMAN PRESCRIPTION DRUG LABEL	1	71715-002	TABLET, FILM COATED	150 mg	ORAL	NDA	33 sections

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