Xenleta is a drug owned by Nabriva Therapeutics Ireland Dac. It is protected by 4 US drug patents filed in 2019. Out of these, 3 drug patents are active and 1 has expired. Xenleta's patents will be open to challenges from 19 August, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be May 23, 2031. Details of Xenleta'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. | |||
| US9120727 | Process for the preparation of pleuromutilins |
May, 2031
(6 years from now) | Active |
| US8071643 | Pleuromutilin derivatives for the treatment of diseases mediated by microbes |
Jan, 2029
(4 years from now) | Active |
| US8153689 | Pleuromutilin derivatives for the treatment of diseases mediated by microbes |
Mar, 2028
(3 years from now) | Active |
| US6753445 | Pleuromutilin derivatives having antibacterial activity |
Jul, 2021
(3 years ago) |
Expired
|
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 Xenleta's patents.
Latest Legal Activities on Xenleta's Patents
Given below is the list of recent legal activities going on the following patents of Xenleta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 02 Oct, 2023 | US8153689 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 23 May, 2023 | US8071643 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 22 Feb, 2023 | US9120727 |
| Patent Term Extension Certificate Critical | 15 Feb, 2023 | US8071643 |
| Withdrawal of Application for PTE Critical | 14 Feb, 2023 | US9120727 |
| Withdrawal of Application for PTE Critical | 14 Feb, 2023 | US8153689 |
| Notice of Final Determination -Election Required | 05 Jan, 2023 | US8071643 |
| Notice of Final Determination -Election Required | 05 Jan, 2023 | US8153689 |
| Notice of Final Determination -Election Required | 05 Jan, 2023 | US9120727 |
| transaction for FDA Determination of Regulatory Review Period | 28 Sep, 2022 | US8071643 |
FDA has granted several exclusivities to Xenleta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xenleta, 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 Xenleta.
Exclusivity Information
Xenleta holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Xenleta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 19, 2024 |
| Generating Antibiotic Incentives Now(GAIN) | Aug 19, 2029 |
US patents provide insights into the exclusivity only within the United States, but Xenleta 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 Xenleta's family patents as well as insights into ongoing legal events on those patents.
Xenleta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xenleta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 23, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xenleta Generics:
There are no approved generic versions for Xenleta as of now.
About Xenleta
Xenleta is a drug owned by Nabriva Therapeutics Ireland Dac. It is used for treating community-acquired bacterial pneumonia in adults. Xenleta uses Lefamulin Acetate as an active ingredient. Xenleta was launched by Nabriva in 2019.
Approval Date:
Xenleta was approved by FDA for market use on 19 August, 2019.
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 Xenleta is 19 August, 2019, its NCE-1 date is estimated to be 19 August, 2028.
Active Ingredient:
Xenleta uses Lefamulin Acetate as the active ingredient. Check out other Drugs and Companies using Lefamulin Acetate ingredient
Treatment:
Xenleta is used for treating community-acquired bacterial pneumonia in adults.
Dosage:
Xenleta is available in the following dosage forms - solution form for intravenous use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 600MG BASE | TABLET | Prescription | ORAL |
| EQ 150MG BASE/15ML (EQ 10MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |