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Last Updated: August 19, 2022

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 eighty-nine 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 Generic Entry Opportunity 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
The University of QueenslandPhase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA

Methods for treating intrapulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA

Synthesis of cephalosporin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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

Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION

Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION

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

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

Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (VABP)

Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA (HABP)

Cephem compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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)

Cephem compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS FOR TREATING BACTERIAL INFECTIONS

Cephem compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS OF TREATING BACTERIAL ILLNESSES

Tazobactam arginine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tazobactam arginine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS OF TREATING BACTERIAL ILLNESSES

Solid forms of ceftolozane
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS

Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating intrapulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA

Methods for treating intrapulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA

Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ZERBAXA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 0204558
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 80347
Estimated Expiration: See Plans and Pricing

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
Hungary S1600008 See Plans and Pricing
Japan 2019151668 セフトロザン抗生物質組成物 (CEFTOLOZANE ANTIBIOTIC COMPOSITIONS) See Plans and Pricing
Portugal 1556389 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZERBAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1556389 602 Finland See Plans and Pricing
1556389 1690003-7 Sweden See Plans and Pricing PRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918
1556389 CR 2016 00004 Denmark See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Baxter
McKinsey
Boehringer Ingelheim
AstraZeneca

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.