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

Stem definition	Drug id	CAS RN
antibiotics, cefalosporanic acid derivatives	4922	689293-68-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: FR-264205 FR 264205 ceftolozane ceftolozane sulfate zerbaxa CXA-101 FR264205	Ceftolozane belongs to the cephalosporin class of antibacterial drugs. The bactericidal action of ceftolozane results from inhibition of cell wall biosynthesis, and is mediated through binding to penicillin-binding proteins (PBPs). Ceftolozane is an inhibitor of PBPs of P. aeruginosa (e.g., PBP1b, PBP1c, and PBP3) and E. coli (e.g., PBP3). Molecular weight: 667.70 Formula: C23H31N12O8S2 CLOGP: -9.85 LIPINSKI: 3 HAC: 20 HDO: 8 TPSA: 299.38 ALOGS: -4.03 ROTB: 12 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

FR-264205
FR 264205
ceftolozane
ceftolozane sulfate
zerbaxa
CXA-101
FR264205

Ceftolozane belongs to the cephalosporin class of antibacterial drugs. The bactericidal action of ceftolozane results from inhibition of cell wall biosynthesis, and is mediated through binding to penicillin-binding proteins (PBPs). Ceftolozane is an inhibitor of PBPs of P. aeruginosa (e.g., PBP1b, PBP1c, and PBP3) and E. coli (e.g., PBP3).

Molecular weight: 667.70
Formula: C23H31N12O8S2
CLOGP: -9.85
LIPINSKI: 3
HAC: 20
HDO: 8
TPSA: 299.38
ALOGS: -4.03
ROTB: 12

Status: ONP

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

Drug dosage:

Dose	Unit	Route
3	g	P

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Hosey CM, Chan R, Benet LZ
t_half (Half-life)	2.58 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.16 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.81 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.17 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

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Date	Agency	Company
Dec. 19, 2014	FDA	CUBIST PHARMS
Jan. 8, 2019	PMDA	MSD K.K.
Sept. 18, 2015	EMA	MERCK SHARP & DOHME B.V.

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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:

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Source	Code	Description
ATC	J01DI54	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Other cephalosporins and penems
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:35441	antiinfective agents
FDA CS	M0003827	Cephalosporins
FDA EPC	N0000175488	Cephalosporin Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000892	Anti-Infective Agents, Urinary
MeSH PA	D065093	beta-Lactamase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors

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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
Abscess of liver	indication	27916005
Acute pyelonephritis	indication	36689008	DOID:559
Urinary tract infectious disease	indication	68566005
Haemophilus influenzae pneumonia	indication	70036007
Abdominal abscess	indication	75100008
Cholecystitis	indication	76581006	DOID:1949
Infectious disease of abdomen	indication	128070006
Bacterial peritonitis	indication	197171003
Bacterial cystitis	indication	424551004
Nosocomial pneumonia	indication	425464007

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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	2.97	acidic
pKa2	3.5	acidic
pKa3	11.54	acidic
pKa4	12.82	acidic
pKa5	13.65	acidic
pKa6	9.85	Basic
pKa7	4.05	Basic
pKa8	0.73	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 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	METHODS FOR TREATING BACTERIAL INFECTIONS
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	7129232	May 15, 2028	METHODS OF TREATING BACTERIAL ILLNESSES
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10028963	Sept. 7, 2032	TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10028963	Sept. 7, 2032	TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	9724353	Sept. 7, 2032	TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	9724353	Sept. 7, 2032	TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	8685957	Sept. 27, 2032	METHODS OF TREATING BACTERIAL ILLNESSES
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	10420841	March 14, 2034	COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)

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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 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	Dec. 19, 2019	NEW CHEMICAL ENTITY
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	Dec. 19, 2024	GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	ZERBAXA	CUBIST PHARMS LLC	N206829	Dec. 19, 2014	RX	POWDER	INTRAVENOUS	April 21, 2025	NEW PATIENT POPULATION

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Bioactivity Summary:

None

External reference:

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ID	Source
015822	NDDF
015823	NDDF
10788	IUPHAR_LIGAND_ID
1597608	RXNORM
231579	MMSL
30783	MMSL
37A4IES95Q	UNII
4034035	VANDF
4034036	VUID
4034036	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ZERBAXA	HUMAN PRESCRIPTION DRUG LABEL	2	67919-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	NDA	28 sections
ZERBAXA	HUMAN PRESCRIPTION DRUG LABEL	2	67919-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	NDA	28 sections
ZERBAXA	HUMAN PRESCRIPTION DRUG LABEL	2	67919-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	NDA	28 sections

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