Tazobactam - PharmaKB

Zosyn, Zerbaxa(tazobactam)

Piperacillin / Tazobactam, Zerbaxa, Zosyn (tazobactam) is a small molecule pharmaceutical. Tazobactam was first approved as Zosyn on 1993-10-22. It has been approved in Europe to treat bacterial infections.

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Clinical

Drug

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Variants

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Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239

Trade Name

FDA

EMA

Combinations

Zerbaxa, Zosyn (generic drugs available since 2010-10-21)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ceftolozane sulfate

Tazobactam sodium

Tradename	Company	Number	Date	Products
ZERBAXA	Cubist Pharmaceuticals	N-206829 RX	2014-12-19	1 products, RLD, RS

Piperacillin sodium

Tazobactam sodium

Tradename	Company	Number	Date	Products
ZOSYN IN PLASTIC CONTAINER	Baxter	N-050750 RX	1998-02-24	3 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
zerbaxa	New Drug Application	2023-11-21

Indications

FDA

EMA

No data

Agency Specific

FDA

EMA

Expiration	Code
CEFTOLOZANE SULFATE / TAZOBACTAM SODIUM, ZERBAXA, CUBIST PHARMS LLC
2025-04-21	NPP
2024-12-19	GAIN
2019-12-19	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
Ceftolozane Sulfate / Tazobactam Sodium, Zerbaxa, Cubist Pharms Llc
10125149	2035-08-14	DP
10376496	2034-09-09		U-2610, U-2611
10933053	2034-09-09		U-3090, U-3091
8906898	2034-05-28	DS, DP
8968753	2034-03-14		U-1672, U-1673, U-3360, U-3361
9320740	2034-03-14	DP
9872906	2034-03-14	DP
10420841	2034-03-14		U-1672, U-2631, U-3360, U-3361
11278622	2034-03-14		U-3335, U-3336
8476425	2032-09-27	DP
8685957	2032-09-27	DP	U-36
9724353	2032-09-07		U-2565, U-2566
10028963	2032-09-07		U-2565, U-2566
7129232	2028-05-15	DS, DP	U-36, U-1676, U-3360, U-3361

ATC Codes

J: Antiinfectives for systemic use

— J01: Antibacterials for systemic use

— J01C: Beta-lactam antibacterials, penicillins

— J01CG: Beta-lactamase inhibitors, systemic penicillins

— J01CG02: Tazobactam

HCPCS

Code	Description
J0695	Injection, ceftolozane 50 mg and tazobactam 25 mg
J2543	Injection, piperacillin sodium/tazobactam sodium, 1 gram/0.125 grams (1.125 grams)

Clinical

Clinical Trials

214 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sepsis	D018805	HP_0100806	A41.9	1	—	2	4	11	18
Pneumonia	D011014	EFO_0003106	—	2	2	4	4	5	16
Bacterial infections	D001424	—	A49	2	—	—	5	6	13
Infections	D007239	EFO_0000544	—	1	—	1	3	7	12
Appendicitis	D001064	EFO_0007149	K37	—	1	—	5	6	12
Septic shock	D012772	—	A48.3	—	—	3	3	5	11
Urinary tract infections	D014552	EFO_0003103	N39.0	—	3	5	1	2	10
Febrile neutropenia	D064147	—	—	—	2	—	4	2	8
Cystic fibrosis	D003550	EFO_0000390	E84	—	—	—	4	3	7
Acute kidney injury	D058186	HP_0001919	N17	—	—	—	1	6	7

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Intraabdominal infections	D059413	—	—	—	3	4	—	1	7
Ventilator-associated pneumonia	D053717	EFO_1001865	J95.851	—	—	5	—	1	6
Pyelonephritis	D011704	EFO_1001141	N10-N16	—	3	4	—	—	6
Healthcare-associated pneumonia	D000077299	—	—	1	1	3	—	1	5
Inflammation	D007249	MP_0001845	—	—	—	1	—	1	2
Surgical wound infection	D013530	—	—	—	—	2	—	—	2
Acute cholecystitis	D041881	EFO_1001289	K81.0	—	—	1	—	1	2
Iatrogenic disease	D007049	—	—	—	—	2	—	—	2
Neoplasms	D009369	—	C80	—	1	1	—	—	2
Leukemia	D007938	—	C95	—	—	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Critical illness	D016638	—	—	1	1	—	—	8	10
Cross infection	D003428	—	—	—	1	—	—	2	3
Osteomyelitis	D010019	EFO_0003102	M86	1	1	—	—	—	2
Systemic inflammatory response syndrome	D018746	EFO_1001478	R65.10	—	1	—	—	1	2
Gastrointestinal microbiome	D000069196	—	—	—	1	—	—	—	1
Otitis media	D010033	EFO_0004992	H66.9	1	1	—	—	—	1
Graft vs host disease	D006086	—	D89.81	—	1	—	—	—	1
Pancreatic fistula	D010185	—	—	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	4	—	—	—	1	5
Renal insufficiency	D051437	HP_0000083	N19	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neutropenia	D009503	—	D70	—	—	—	—	3	3
Peritonitis	D010538	EFO_0008588	K65	—	—	—	—	2	2
Drug monitoring	D016903	—	—	—	—	—	—	2	2
Neonatal sepsis	D000071074	HP_0040187	—	—	—	—	—	2	2
Hematopoietic stem cell transplantation	D018380	—	—	—	—	—	—	2	2
Gram-positive bacterial infections	D016908	—	—	—	—	—	—	2	2
Cytokine release syndrome	D000080424	—	D89.83	—	—	—	—	1	1
Viral pneumonia	D011024	EFO_0007541	J12.9	—	—	—	—	1	1
Chronic bronchitis	D029481	—	J42	—	—	—	—	1	1
Mycoses	D009181	—	B35-B49	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Tazobactam
INN	tazobactam
Description	Tazobactam is a member of the class of penicillanic acids that is sulbactam in which one of the exocyclic methyl hydrogens is replaced by a 1,2,3-triazol-1-yl group; used (in the form of its sodium salt) in combination with ceftolozane sulfate for treatment of complicated intra-abdominal infections and complicated urinary tract infections. It has a role as an antimicrobial agent, an antiinfective agent and an EC 3.5.2.6 (beta-lactamase) inhibitor. It is a member of penicillanic acids and a member of triazoles. It is functionally related to a sulbactam. It is a conjugate acid of a tazobactam(1-).
Classification	Small molecule
Drug class	beta-lactamase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C[C@]1(Cn2ccnn2)[C@H](C(=O)O)N2C(=O)C[C@H]2S1(=O)=O