DrugPatentWatch Database Preview
ZERBAXA Drug Profile
Email this page to a colleague
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 thirteen patents protecting this drug.
This drug has eighty-one patent family members in thirty 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
Summary for ZERBAXA
| International Patents: | 81 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZERBAXA |
| What excipients (inactive ingredients) are in ZERBAXA? | ZERBAXA excipients list |
| DailyMed Link: | ZERBAXA at DailyMed |
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
| 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 | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;INTRAVENOUS | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;INTRAVENOUS | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >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 |
|---|---|---|
| European Patent Office | 2862569 | Try Before You Buy |
| Japan | 6151257 | Try Before You Buy |
| Australia | 2014233633 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZERBAXA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1556389 | 6/2016 | Austria | Try Before You Buy | PRODUCT NAME: CEFTOLOZAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE EIN SCHWEFELSAEURESALZ; REGISTRATION NO/DATE: EU/1/15/1032/001 (MITTEILUNG) 20150922 |
| 1556389 | 602 | Finland | Try Before You Buy | |
| 1556389 | C01556389/01 | Switzerland | Try Before You Buy | PRODUCT NAME: CEFTOLOZAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65472 03.03.2016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
