The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Defitelio
defibrotide sodium · DEFIBROTIDE SODIUM 80 mg/mL · Injection, Solution · Intravenous · Jazz Pharmaceuticals, Inc.
NDC 68727-0800-01 · 2.5 mL 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.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Gentium S.r.LItalyanalysis · api manufacture
- manufacture
- Patheon Italia S.p.AItalymanufacture
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 1 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
- NDA208114
- TE code
- —
- Approval date
- Mar 30, 2016
- Patents / exclusivity
- 5 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 11236328 | Jun 22, 2032 |
| patent | 11085043 | Jun 22, 2032 |
| patent | 12529052 | Jun 22, 2032 |
| patent | 11746348 | Jun 22, 2032 |
| patent | 12534722 | Jun 22, 2032 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of defibrotide sodium (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Jazz Pharmaceuticals, Inc. | DEFIBROTIDE SODIUM 80 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Italia S.p.A. | DEFIBROTIDE SODIUM 80 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Defitelio — NDC 68727-0800-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68727080001.
Free to cite with attribution — see how the data is put together.