Zerbaxa is a drug owned by Cubist Pharmaceuticals Llc. It is protected by 14 US drug patents filed from 2014 to 2022 out of which none have expired yet. Zerbaxa's patents have been open to challenges since 20 December, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 14, 2035. Details of Zerbaxa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8906898 | Solid forms of ceftolozane |
May, 2034
(9 years from now) | Active |
| US8685957 | Tazobactam arginine compositions |
Sep, 2032
(7 years from now) | Active |
| US8476425 | Tazobactam arginine compositions |
Sep, 2032
(7 years from now) | Active |
| US7129232 | Cephem compounds |
May, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10125149 | Synthesis of cephalosporin compounds |
Aug, 2035
(10 years from now) | Active |
| US10376496 | Treating infections with ceftolozane/tazobactam in subjects having impaired renal function |
Sep, 2034
(9 years from now) | Active |
| US10933053 | Treating infections with ceftolozane/tazobactam in subjects having impaired renal function |
Sep, 2034
(9 years from now) | Active |
| US10420841 | Ceftolozane antibiotic compositions |
Mar, 2034
(8 years from now) | Active |
| US9320740 | Ceftolozane-tazobactam pharmaceutical compositions |
Mar, 2034
(8 years from now) | Active |
| US8968753 | Ceftolozane-tazobactam pharmaceutical compositions |
Mar, 2034
(8 years from now) | Active |
| US11278622 | Ceftolozane antibiotic compositions |
Mar, 2034
(8 years from now) | Active |
| US9872906 | Ceftolozane antibiotic compositions |
Mar, 2034
(8 years from now) | Active |
| US10028963 | Methods for treating intrapulmonary infections |
Sep, 2032
(7 years from now) | Active |
| US9724353 | Methods for treating intrapulmonary infections |
Sep, 2032
(7 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zerbaxa's patents.
Latest Legal Activities on Zerbaxa's Patents
Given below is the list of recent legal activities going on the following patents of Zerbaxa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Feb, 2023 | US10420841 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jan, 2023 | US10376496 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 May, 2022 | US8906898 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2022 | US10125149 |
| Recordation of Patent Grant Mailed Critical | 22 Mar, 2022 | US11278622 |
| Patent Issue Date Used in PTA Calculation Critical | 22 Mar, 2022 | US11278622 |
| Email Notification Critical | 03 Mar, 2022 | US11278622 |
| Issue Notification Mailed Critical | 02 Mar, 2022 | US11278622 |
| Application Is Considered Ready for Issue Critical | 10 Feb, 2022 | US11278622 |
| Dispatch to FDC | 10 Feb, 2022 | US11278622 |
FDA has granted several exclusivities to Zerbaxa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zerbaxa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zerbaxa.
Exclusivity Information
Zerbaxa holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Zerbaxa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2019 |
| Generating Antibiotic Incentives Now(GAIN) | Dec 19, 2024 |
| New Patient Population(NPP) | Apr 21, 2025 |
Several oppositions have been filed on Zerbaxa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Zerbaxa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zerbaxa patents.
Zerbaxa's Oppositions Filed in EPO
Zerbaxa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 21, 2020, by Lederer & Keller Patentanwälte Partnerschaft Mbb. This opposition was filed on patent number EP14842042A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14842042A | Dec, 2020 | Lederer & Keller Patentanwälte Partnerschaft mbB | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Zerbaxa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zerbaxa's family patents as well as insights into ongoing legal events on those patents.
Zerbaxa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zerbaxa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 14, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zerbaxa Generics:
There are no approved generic versions for Zerbaxa as of now.
About Zerbaxa
Zerbaxa is a drug owned by Cubist Pharmaceuticals Llc. It is used for treating complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia. Zerbaxa uses Ceftolozane Sulfate; Tazobactam Sodium as an active ingredient. Zerbaxa was launched by Cubist Pharms Llc in 2014.
Approval Date:
Zerbaxa was approved by FDA for market use on 19 December, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zerbaxa is 19 December, 2014, its NCE-1 date is estimated to be 20 December, 2023.
Active Ingredient:
Zerbaxa uses Ceftolozane Sulfate; Tazobactam Sodium as the active ingredient. Check out other Drugs and Companies using Ceftolozane Sulfate; Tazobactam Sodium ingredient
Treatment:
Zerbaxa is used for treating complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.
Dosage:
Zerbaxa is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL | POWDER | Prescription | INTRAVENOUS |