Xacduro (copackaged) is a drug owned by Entasis Therapeutics Inc. It is protected by 4 US drug patents filed in 2023 out of which none have expired yet. Xacduro (Copackaged)'s patents will be open to challenges from 23 May, 2032. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 17, 2035. Details of Xacduro (copackaged)'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. | |||
| US9309245 | Beta-lactamase inhibitor compounds |
Apr, 2033
(8 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). | |||
| US9968593 | Combination therapy for treatment of resistant bacterial infections |
Nov, 2035
(10 years from now) | Active |
| US10376499 | Combination therapy for treatment of resistant bacterial infections |
Nov, 2035
(10 years from now) | Active |
| US9623014 | β-lactamase inhibitor compounds |
Apr, 2033
(8 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 Xacduro (copackaged)'s patents.
Latest Legal Activities on Xacduro (copackaged)'s Patents
Given below is the list of recent legal activities going on the following patents of Xacduro (copackaged).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination- Ineligible | 26 Apr, 2024 | US9309245 |
| Notice of Final Determination- Ineligible | 26 Apr, 2024 | US10376499 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US10376499 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US9309245 |
| Initial letter Re: PTE Application to regulating agency | 17 Jan, 2024 | US10376499 |
| Initial letter Re: PTE Application to regulating agency | 17 Jan, 2024 | US9309245 |
| Requirement for information sent under 37 CFR 1.750 | 17 Nov, 2023 | US10376499 |
| Requirement for information sent under 37 CFR 1.750 | 17 Nov, 2023 | US9309245 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Oct, 2023 | US9309245 |
| Requirement for information sent under 37 CFR 1.750 | 09 Aug, 2023 | US10376499 |
FDA has granted several exclusivities to Xacduro (copackaged). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xacduro (copackaged), 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 Xacduro (copackaged).
Exclusivity Information
Xacduro (copackaged) holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2033. Details of Xacduro (copackaged)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 23, 2028 |
| Generating Antibiotic Incentives Now(GAIN) | May 23, 2033 |
US patents provide insights into the exclusivity only within the United States, but Xacduro (copackaged) 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 Xacduro (copackaged)'s family patents as well as insights into ongoing legal events on those patents.
Xacduro (copackaged)'s Family Patents
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Generic Launch
Generic Release Date:
Xacduro (copackaged)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 17, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xacduro (copackaged) Generics:
There are no approved generic versions for Xacduro (copackaged) as of now.
About Xacduro (copackaged)
Xacduro (Copackaged) is a drug owned by Entasis Therapeutics Inc. It is used for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Xacduro (Copackaged) uses Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium as an active ingredient. Xacduro (Copackaged) was launched by Entasis Therap in 2023.
Approval Date:
Xacduro (copackaged) was approved by FDA for market use on 23 May, 2023.
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 Xacduro (copackaged) is 23 May, 2023, its NCE-1 date is estimated to be 23 May, 2032.
Active Ingredient:
Xacduro (copackaged) uses Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium as the active ingredient. Check out other Drugs and Companies using Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium ingredient
Treatment:
Xacduro (copackaged) is used for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
Dosage:
Xacduro (copackaged) is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL | POWDER | Prescription | INTRAVENOUS |