Pepaxto is a drug owned by Oncopeptides Ab. It is protected by 6 US drug patents filed from 2021 to 2022. Out of these, 5 drug patents are active and 1 has expired. Pepaxto's patents have been open to challenges since 26 February, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 25, 2032. Details of Pepaxto'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. | |||
| US6992207 | Melphalan derivatives and their use as cancer chemotherapeutic drugs |
Jun, 2024
(10 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10543274 | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(6 years from now) | Active |
| US11344622 | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(6 years from now) | Active |
| US10285946 | Lyophilized preparations of melphalan flufenamide |
Apr, 2032
(6 years from now) | Active |
| US10869928 | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(6 years from now) | Active |
| US10322182 | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(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 Pepaxto's patents.
Latest Legal Activities on Pepaxto's Patents
Given below is the list of recent legal activities going on the following patents of Pepaxto.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Interim Patent Term Extension Granted Critical | 24 Jun, 2024 | US6992207 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 05 Jun, 2024 | US10869928 |
| Requirement for information sent under 37 CFR 1.750 | 13 May, 2024 | US6992207 |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Apr, 2024 | US6992207 |
| PTE Interim Patent Extension filed Critical | 22 Mar, 2024 | US6992207 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 12 Jul, 2023 | US10543274 |
| Interim Patent Term Extension Granted Critical | 06 Jun, 2023 | US6992207 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 30 Nov, 2022 | US10322182 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 02 Nov, 2022 | US10285946 |
| Patent Issue Date Used in PTA Calculation Critical | 31 May, 2022 | US11344622 |
FDA has granted several exclusivities to Pepaxto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pepaxto, 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 Pepaxto.
Exclusivity Information
Pepaxto holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Pepaxto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 26, 2026 |
| Orphan Drug Exclusivity(ODE-348) | Feb 26, 2028 |
US patents provide insights into the exclusivity only within the United States, but Pepaxto 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 Pepaxto's family patents as well as insights into ongoing legal events on those patents.
Pepaxto's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pepaxto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 25, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pepaxto Generics:
There are no approved generic versions for Pepaxto as of now.
About Pepaxto
Pepaxto is a drug owned by Oncopeptides Ab. It is used for treating relapsed or refractory multiple myeloma in adults who have received at least 4 prior lines of therapy. Pepaxto uses Melphalan Flufenamide Hydrochloride as an active ingredient. Pepaxto was launched by Oncopeptides Ab in 2021.
Approval Date:
Pepaxto was approved by FDA for market use on 26 February, 2021.
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 Pepaxto is 26 February, 2021, its NCE-1 date is estimated to be 26 February, 2025.
Active Ingredient:
Pepaxto uses Melphalan Flufenamide Hydrochloride as the active ingredient. Check out other Drugs and Companies using Melphalan Flufenamide Hydrochloride ingredient
Treatment:
Pepaxto is used for treating relapsed or refractory multiple myeloma in adults who have received at least 4 prior lines of therapy.
Dosage:
Pepaxto is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE/VIAL | POWDER | Discontinued | INTRAVENOUS |