ZERBAXA Drug Patent Profile
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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 fourteen patents protecting this drug.
This drug has eighty-nine patent family members in thirty-two 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: | 89 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 6 |
| 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 |
|---|---|
| Hamad Medical Corporation | Phase 4 |
| University Hospital, Toulouse | Phase 3 |
| The University of Queensland | Phase 1/Phase 2 |
Pharmacology for ZERBAXA
| Drug Class | Cephalosporin Antibacterial beta Lactamase Inhibitor |
| Mechanism of Action | beta Lactamase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ZERBAXA
US Patents and Regulatory Information for ZERBAXA
ZERBAXA is protected by twenty-eight US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZERBAXA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZERBAXA
Methods for treating intrapulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA
Methods for treating intrapulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA
Synthesis of cephalosporin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS
Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS
Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)
Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION
Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION
Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS
Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA IN PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS
Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (VABP)
Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA (HABP)
Cephem compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)
Cephem compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
Cephem compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS FOR TREATING BACTERIAL INFECTIONS
Cephem compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS OF TREATING BACTERIAL ILLNESSES
Tazobactam arginine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Tazobactam arginine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS OF TREATING BACTERIAL ILLNESSES
Solid forms of ceftolozane
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)
Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION
Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS
Ceftolozane-tazobactam pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods for treating intrapulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA
Methods for treating intrapulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA
Ceftolozane antibiotic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting ZERBAXA
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;INTRAVENOUS | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;INTRAVENOUS | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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
When does loss-of-exclusivity occur for ZERBAXA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
China
Patent: 6795175
Estimated Expiration: See Plans and Pricing
Patent: 0204558
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 80347
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ZERBAXA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | S1600008 | See Plans and Pricing | |
| Japan | 2019151668 | セフトロザン抗生物質組成物 (CEFTOLOZANE ANTIBIOTIC COMPOSITIONS) | See Plans and Pricing |
| Portugal | 1556389 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZERBAXA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1556389 | 602 | Finland | See Plans and Pricing | |
| 1556389 | 1690003-7 | Sweden | See Plans and Pricing | PRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918 |
| 1556389 | CR 2016 00004 | Denmark | See Plans and Pricing | 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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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 verification 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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