The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Grafapex
treosulfan · TREOSULFAN 1000 mg/g · Injection, Powder, Lyophilized, For Solution · Intravenous · Medexus Pharma, Inc.
NDC 59137-0335-01 · 1 VIAL in 1 CARTON / 1 g in 1 VIAL · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$610.00
Reported to Texas DSHS · 2026 annual filing · Medexus Pharma Inc
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 50 MG
$32.330
HCPCS J0614 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- medac pharma production GmbHGermanyanalysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA214759
- TE code
- —
- Approval date
- Jan 21, 2025
- Patents / exclusivity
- 2 patents, 6 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-514 | Jan 21, 2032 |
| exclusivity | ODE-513 | Jan 21, 2032 |
| exclusivity | ODE-514 | Jan 21, 2032 |
| exclusivity | ODE-513 | Jan 21, 2032 |
| exclusivity | NCE | Jan 21, 2030 |
| exclusivity | NCE | Jan 21, 2030 |
| patent | 7199162 | Oct 12, 2026 |
| patent | 7199162 | Oct 12, 2026 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of treosulfan (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Medexus Pharma, Inc. | TREOSULFAN 1000 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Medexus Pharma, Inc. | TREOSULFAN 5000 mg/5g | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Grafapex — NDC 59137-0335-01," retrieved September 3, 2026, https://drugdashboards.com/drug/59137033501.
Free to cite with attribution — see how the data is put together.