Grafapex is a drug owned by Medexus Pharma Inc. It is protected by 1 US drug patent filed in 2025 out of which none have expired yet. Grafapex's patents will be open to challenges from 21 January, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 21, 2032. Details of Grafapex's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7199162 | Use of treosulfan for patient conditioning before bone marrow or blood stem cell transplantation |
Mar, 2026
(6 days 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 Grafapex's patents.
Latest Legal Activities on Grafapex's Patents
Given below is the list of recent legal activities going on the following patents of Grafapex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 26 Aug, 2025 | US7199162 |
| Second letter to regulating agency to determine regulatory review period | 09 Jul, 2025 | US7199162 |
| Letter from FDA or Dept of Agriculture re PTE application | 27 Jun, 2025 | US7199162 |
| Interim Patent Term Extension Granted | 20 Mar, 2025 | US7199162 |
| Initial letter Re: PTE Application to regulating agency | 13 Mar, 2025 | US7199162 |
| PTE Interim Patent Extension filed | 28 Feb, 2025 | US7199162 |
| Patent Term Extension Application under 35 USC 156 Filed | 28 Feb, 2025 | US7199162 |
| Interim Patent Term Extension Granted | 01 Oct, 2024 | US7199162 |
| Interim Patent Term Extension Granted | 30 Sep, 2022 | US7199162 |
| Interim Patent Term Extension Granted | 05 Oct, 2021 | US7199162 |
FDA has granted several exclusivities to Grafapex. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Grafapex, 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
Grafapex.
Exclusivity Information
Grafapex holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2032. Details of Grafapex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 21, 2030 |
| Orphan Drug Exclusivity(ODE-513) | Jan 21, 2032 |
| Orphan Drug Exclusivity(ODE-514) | Jan 21, 2032 |
US patents provide insights into the exclusivity only within the United States, but
Grafapex 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 Grafapex's family patents as well as insights into
ongoing legal events
on those patents.
Grafapex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Grafapex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 21, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Grafapex Generics:
There are no approved generic versions for Grafapex as of now.
About Grafapex
Grafapex is a drug owned by Medexus Pharma Inc. Grafapex uses Treosulfan as an active ingredient. Grafapex was launched by Medexus in 2025.
Approval Date:
Grafapex was approved by FDA for market use on 21 January, 2025.
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 Grafapex is 21 January, 2025, its NCE-1 date is estimated to be 21 January, 2029.
Active Ingredient:
Grafapex uses Treosulfan as the active ingredient. Check out other Drugs and Companies using Treosulfan ingredient
Dosage:
Grafapex is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/VIAL | POWDER | Prescription | INTRAVENOUS |
| 5GM/VIAL | POWDER | Prescription | INTRAVENOUS |