Exblifep is a drug owned by Allecra Therapeutics Sas. It is protected by 2 US drug patents filed in 2024 out of which none have expired yet. Exblifep's patents will be open to challenges from 22 February, 2033. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 07, 2034. Details of Exblifep'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. | |||
| US7687488 | 2-substituted methyl penam derivatives |
Dec, 2027
(2 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). | |||
| US11124526 | Crystalline beta-lactamase inhibitor |
Nov, 2034
(9 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 Exblifep's patents.
Latest Legal Activities on Exblifep's Patents
Given below is the list of recent legal activities going on the following patents of Exblifep.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 03 Jul, 2024 | US7687488 |
| Email Notification Critical | 03 Jul, 2024 | US7687488 |
| Requirement for information sent under 37 CFR 1.750 | 25 Apr, 2024 | US7687488 |
| Initial letter Re: PTE Application to regulating agency | 25 Apr, 2024 | US11124526 |
| Initial letter Re: PTE Application to regulating agency | 25 Apr, 2024 | US7687488 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Sep, 2021 | US7687488 |
| Recordation of Patent Grant Mailed Critical | 21 Sep, 2021 | US11124526 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Sep, 2021 | US11124526 |
| Email Notification Critical | 02 Sep, 2021 | US11124526 |
| Issue Notification Mailed Critical | 01 Sep, 2021 | US11124526 |
FDA has granted several exclusivities to Exblifep. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exblifep, 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 Exblifep.
Exclusivity Information
Exblifep holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2034. Details of Exblifep's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 22, 2029 |
| Generating Antibiotic Incentives Now(GAIN) | Feb 22, 2034 |
US patents provide insights into the exclusivity only within the United States, but Exblifep 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 Exblifep's family patents as well as insights into ongoing legal events on those patents.
Exblifep's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exblifep's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 07, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exblifep Generics:
There are no approved generic versions for Exblifep as of now.
About Exblifep
Exblifep is a drug owned by Allecra Therapeutics Sas. It is used for treating complicated urinary tract infections (CUTI) including pyelonephritis caused by designated susceptible microorganisms. Exblifep uses Cefepime Hydrochloride; Enmetazobactam as an active ingredient. Exblifep was launched by Allecra Theraps in 2024.
Approval Date:
Exblifep was approved by FDA for market use on 22 February, 2024.
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 Exblifep is 22 February, 2024, its NCE-1 date is estimated to be 22 February, 2033.
Active Ingredient:
Exblifep uses Cefepime Hydrochloride; Enmetazobactam as the active ingredient. Check out other Drugs and Companies using Cefepime Hydrochloride; Enmetazobactam ingredient
Treatment:
Exblifep is used for treating complicated urinary tract infections (CUTI) including pyelonephritis caused by designated susceptible microorganisms.
Dosage:
Exblifep is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2GM BASE/VIAL;0.5GM/VIAL | POWDER | Discontinued | INTRAVENOUS |