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Last Updated: March 19, 2024

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ZERBAXA Drug Patent Profile


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Which patents cover Zerbaxa, and when can generic versions of Zerbaxa launch?

Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has ninety-three patent family members in thirty-two countries.

The generic ingredient in ZERBAXA is ceftolozane sulfate; tazobactam sodium. One supplier is listed for this compound. Additional details are available on the ceftolozane sulfate; tazobactam sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Zerbaxa

Zerbaxa was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZERBAXA
Drug patent expirations by year for ZERBAXA
Drug Prices for ZERBAXA

See drug prices for ZERBAXA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZERBAXA
Generic Entry Date for ZERBAXA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZERBAXA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hamad Medical CorporationPhase 4
University Hospital, ToulousePhase 3
Royal Brisbane and Women's HospitalPhase 1/Phase 2

See all ZERBAXA clinical trials

Pharmacology for ZERBAXA

US Patents and Regulatory Information for ZERBAXA

ZERBAXA is protected by twenty-eight US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZERBAXA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZERBAXA

Methods for treating intrapulmonary infections
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA

Methods for treating intrapulmonary infections
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA

Synthesis of cephalosporin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS

Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS

Ceftolozane antibiotic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION

Ceftolozane antibiotic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION

Ceftolozane antibiotic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)

Ceftolozane antibiotic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)

Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS

Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS

Ceftolozane antibiotic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA (HABP)

Ceftolozane antibiotic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (VABP)

Cephem compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHODS OF TREATING BACTERIAL ILLNESSES

Cephem compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHODS FOR TREATING BACTERIAL INFECTIONS

Cephem compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)

Cephem compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)

Tazobactam arginine compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tazobactam arginine compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHODS OF TREATING BACTERIAL ILLNESSES

Solid forms of ceftolozane
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for treating intrapulmonary infections
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA

Methods for treating intrapulmonary infections
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA

Ceftolozane antibiotic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting ZERBAXA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ZERBAXA

When does loss-of-exclusivity occur for ZERBAXA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

Patent: 6795175
Estimated Expiration: ⤷  Try a Trial

Patent: 0204558
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 80347
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZERBAXA around the world.

Country Patent Number Title Estimated Expiration
South Korea 102329764 ⤷  Try a Trial
Brazil 112015023523 composições dos antibióticos de ceftolozane ⤷  Try a Trial
Austria 368042 ⤷  Try a Trial
Netherlands 300793 ⤷  Try a Trial
Japan 2014526468 ⤷  Try a Trial
Hong Kong 1200096 治療肺內感染的方法 (METHODS FOR TREATING INTRAPULMONARY INFECTIONS) ⤷  Try a Trial
Brazil PI0315188 composto e composição farmacêutica ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZERBAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1556389 C01556389/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CEFTOLOZAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65472 03.03.2016
1556389 2015/074 Ireland ⤷  Try a Trial PRODUCT NAME: CEFTOLOZANE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR A SULFURIC ACID SALT; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918
1556389 1690003-7 Sweden ⤷  Try a Trial PRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918
1556389 602 Finland ⤷  Try a Trial
1556389 CR 2016 00004 Denmark ⤷  Try a Trial PRODUCT NAME: CEFTOLOZAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT ET SVOVLSYRESALT; REG. NO/DATE: EU/1/15/1032/001 20150922
1556389 SPC/GB16/002 United Kingdom ⤷  Try a Trial PRODUCT NAME: CEFTOLOZANE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR A SULFURIC ACID SALT.; REGISTERED: UK EU/1/15/1032 20150922
1556389 CA 2016 00004 Denmark ⤷  Try a Trial PRODUCT NAME: CEFTOLOZAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT ET SVOVLSYRESALT; REG. NO/DATE: EU/1/15/1032/001 20150922
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.