DrugPatentWatch Database Preview
ZERBAXA Drug Profile
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 eleven patents protecting this drug.
This drug has seventy-five 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.
Summary for ZERBAXA
| International Patents: | 75 |
| US Patents: | 11 |
| 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;IV (INFUSION) |
*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 |
| Hartford Hospital | Phase 1 |
| Merck Sharp & Dohme Corp. | 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 | 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 | ||||
| >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 |
|---|---|---|
| Japan | 4448821 | Start Trial |
| Morocco | 38426 | Start Trial |
| Australia | 2016202199 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZERBAXA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1556389 | 300793 | Netherlands | Start Trial | PRODUCT NAME: CEFTOLOZAAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN IN HET BIJZONDER EEN ZWAVELZUURZOUT; REGISTRATION NO/DATE: EU/1/15/1032 20150922 |
| 1556389 | CR 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 |
| 1556389 | 122015000113 | Germany | Start Trial | PRODUCT NAME: CEFTOLOZAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, INSBESONDERE EIN SCHWEFELSAEURESALZ; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
