Avycaz is a drug owned by Allergan Sales Llc. It is protected by 8 US drug patents filed from 2015 to 2017. Out of these, 7 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 15, 2032. Details of Avycaz's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8178554 | Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents |
Jul, 2021
(3 years ago) |
Expired
|
| US7112592 | Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents |
Jan, 2026
(1 year, 5 months from now) | Active |
| US8471025 | Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt |
Aug, 2031
(7 years from now) | Active |
| US8969566 | Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof |
Jun, 2032
(7 years from now) | Active |
| US9284314 | Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof |
Jun, 2032
(7 years from now) | Active |
| US9695122 | Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof |
Jun, 2032
(7 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7612087 | Heterocyclic compounds as inhibitors of beta-lactamases |
Nov, 2026
(2 years from now) | Active |
| US8835455 | Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt |
Oct, 2030
(6 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 Avycaz's patents.
Latest Legal Activities on Avycaz's Patents
Given below is the list of recent legal activities going on the following patents of Avycaz.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 17 Jun, 2024 | US8178554 |
| Maintenance Fee Reminder Mailed | 01 Jan, 2024 | US8178554 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Aug, 2023 | US9284314 |
| Post Issue Communication - Certificate of Correction Denied | 25 May, 2023 | US7112592 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Aug, 2022 | US8969566 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Feb, 2022 | US8835455 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 May, 2021 | US7612087 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Jan, 2021 | US9695122 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Dec, 2020 | US8471025 |
| Patent Term Extension Certificate | 22 Jan, 2020 | US7112592 |
FDA has granted several exclusivities to Avycaz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Avycaz, 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 Avycaz.
Exclusivity Information
Avycaz holds 4 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Avycaz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-738) | Jun 22, 2019 |
| New Chemical Entity Exclusivity(NCE) | Feb 25, 2020 |
| Generating Antibiotic Incentives Now(GAIN) | Feb 25, 2025 |
| New Patient Population(NPP) | Dec 20, 2025 |
Several oppositions have been filed on Avycaz'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 Avycaz's generic, the next section provides detailed information on ongoing and past EP oppositions related to Avycaz patents.
Avycaz's oppositions filed in EPO
Avycaz has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 26, 2019, by Lederer & Keller Patentanwälte Partnerschaft Mbb. This opposition was filed on patent number EP17182561A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17182561A | Nov, 2019 | Lederer & Keller Patentanwälte Partnerschaft mbB | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Avycaz 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 Avycaz's family patents as well as insights into ongoing legal events on those patents.
Avycaz's family patents
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Generic Launch
Generic Release Date:
Avycaz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 15, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avycaz Generics:
There are no approved generic versions for Avycaz as of now.
About Avycaz
Avycaz is a drug owned by Allergan Sales Llc. It is used for treating hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infections in both adult and pediatric patients. Avycaz uses Avibactam Sodium; Ceftazidime as an active ingredient. Avycaz was launched by Allergan in 2015.
Market Authorisation Date:
Avycaz was approved by FDA for market use on 25 February, 2015.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Avycaz is 25 February, 2015, its NCE-1 date is estimated to be 26 February, 2024
Active Ingredient:
Avycaz uses Avibactam Sodium; Ceftazidime as the active ingredient. Check out other Drugs and Companies using Avibactam Sodium; Ceftazidime ingredient
Treatment:
Avycaz is used for treating hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infections in both adult and pediatric patients.
Dosage:
Avycaz is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.5GM BASE;2GM/VIAL | POWDER | Prescription | INTRAVENOUS |