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ZERBAXA Drug Profile
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See Plans and PricingWhen 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
Summary for ZERBAXA
| International Patents: | 76 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZERBAXA |
| DailyMed Link: | ZERBAXA at DailyMed |
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
| Sponsor | Phase |
|---|---|
| University Hospital, Toulouse | Phase 3 |
| Merck Sharp & Dohme Corp. | Phase 1 |
| Hartford Hospital | Phase 1 |
Pharmacology for ZERBAXA
| Drug Class | Cephalosporin Antibacterial beta Lactamase Inhibitor |
| Mechanism of Action | beta Lactamase Inhibitors |
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 |
International Patents for ZERBAXA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112015023523 | Start Trial |
| Canada | 2504730 | Start Trial |
| European Patent Office | 2753326 | Start Trial |
| Japan | 4448821 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
