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Last Updated: February 23, 2020

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ZERBAXA Drug Profile


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When do Zerbaxa patents expire, and what generic alternatives are available?

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

This drug has seventy-six patent family members in twenty-eight 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.

US ANDA Litigation and 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

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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
University Hospital, ToulousePhase 3
Merck Sharp & Dohme Corp.Phase 1
Hartford HospitalPhase 1

See all ZERBAXA clinical trials

Pharmacology for ZERBAXA

US Patents and Regulatory Information for ZERBAXA

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

Supplementary Protection Certificates for ZERBAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1556389 16C0004 France   Start Trial PRODUCT NAME: CEFTOLOZANE,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,PLUS PARTICULIEREMENT UN SEL D'ACIDE SULFURIQUE; REGISTRATION NO/DATE: EU/1/15/1032 20150922
1556389 92943 Luxembourg   Start Trial PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922
1556389 1690003-7 Sweden   Start Trial PRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918
1556389 CA 2016 00004 Denmark   Start 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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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Colorcon
Baxter
McKesson
Harvard Business School

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