# DEFITELIO — FDA application NDA208114

Informational only - not investment advice.

Application NDA208114 · type NDA · FDA status: approved · original approval 2016-03-30

Listed sponsor: JAZZ PHARMS INC · [JAZZ company profile](/company/JAZZ/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | DEFITELIO | DEFIBROTIDE SODIUM | SOLUTION | INTRAVENOUS | 200MG/2.5ML (80MG/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 11085043, product 001; listed patent expiry date: 2032-06-22.
- Patent 11236328, product 001; listed patent expiry date: 2032-06-22.
- Patent 11746348, product 001; listed patent expiry date: 2032-06-22.
- Patent 12529052, product 001; listed patent expiry date: 2032-06-22.
- Patent 12534722, product 001; listed patent expiry date: 2032-06-22.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- DEFIBROTIDE SODIUM · UNII L7CHH2B2J0 · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/JAZZ/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA208114. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.