Prescription medicine
Defibrotide Brand names: Defitelio
Defibrotide (Defitelio) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the defibrotide FDA label on DailyMed (effective July 1, 2025, Jazz Pharmaceuticals, Inc.); the NDA 208114 record on Drugs@FDA; every defibrotide label on DailyMed.
Highlights of the record
FDA label of July 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).
Forms and strengths
- 80 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- March 30, 2016 Defitelio, Jazz Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 22, 2032 Defitelio injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,546 through July 30, 2026
What is defibrotide used for?
From the label: indications and usageDEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).
Source: FDA drug label (DEFITELIO), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 2c3db989-d7ad-41ed-9ebf-698dcf6c24ec), via openFDA; the full label on DailyMed
Is there a generic for defibrotide (Defitelio)?
No generic defibrotide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Defitelio injection, the last expiring on June 22, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the defibrotide label say about other medicines?
The defibrotide label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alteplase | drug interactions | DRUG INTERACTIONS Antithrombotic Agents DEFITELIO may enhance the pharmacodynamic activity of antithrombotic/fibrinolytic drugs such as heparin or alteplase. |
| Heparin | drug interactions | DRUG INTERACTIONS Antithrombotic Agents DEFITELIO may enhance the pharmacodynamic activity of antithrombotic/fibrinolytic drugs such as heparin or alteplase. |
Source: FDA drug label (DEFITELIO), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 2c3db989-d7ad-41ed-9ebf-698dcf6c24ec), via openFDA; the full label on DailyMed
What do FAERS reports show for defibrotide?
The FDA Adverse Event Reporting System holds 3,546 reports that list defibrotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,730 are coded as a death and 762 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Defibrotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other