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, 2030. 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 |
Oct, 2025
(6 months from now) | Active |
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 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. 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 |
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
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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, 2030 (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 |