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Generated: August 19, 2017
What is the patent landscape for Zerbaxa, and what generic Zerbaxa alternatives are available?
Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are six patents protecting this drug.| Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Clinical Trials: see list | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ZERBAXA at DailyMed |
| Ingredient-type | Cephalosporins |
| Drug Class | Cephalosporin Antibacterial beta Lactamase Inhibitor |
| Mechanism of Action | beta Lactamase Inhibitors |
| 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;IV (INFUSION) | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;IV (INFUSION) | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;IV (INFUSION) | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;IV (INFUSION) | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;IV (INFUSION) | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,044,485 | Ceftolozane antibiotic compositions | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2893929 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20150135363 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 631761 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 700372 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2777705 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016 00004 | Denmark | ► Subscribe | PRODUCT NAME: CEFTOLOZAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT ET SVOVLSYRESALT; REG. NO/DATE: EU/1/15/1032/001 20150922 | ||||||||||||||||||||||||||
| 943 | Luxembourg | ► Subscribe | PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922 | ||||||||||||||||||||||||||
| C0004 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2015000113 | Germany | ► Subscribe | PRODUCT NAME: CEFTOLOZAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, INSBESONDERE EIN SCHWEFELSAEURESALZ; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918 | ||||||||||||||||||||||||||
| 2016 | Austria | ► Subscribe | PRODUCT NAME: CEFTOLOZAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE EIN SCHWEFELSAEURESALZ; REGISTRATION NO/DATE: EU/1/15/1032/001 (MITTEILUNG) 20150922 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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