DEFITELIO — FDA application NDA208114
Listed sponsor: JAZZ PHARMS INC · JAZZ company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 11085043 | 001 | listed patent expiry date: 2032-06-22 | drug product |
| Patent 11236328 | 001 | listed patent expiry date: 2032-06-22 | U-3301 |
| Patent 11746348 | 001 | listed patent expiry date: 2032-06-22 | drug product |
| Patent 12529052 | 001 | listed patent expiry date: 2032-06-22 | drug product |
| Patent 12534722 | 001 | listed patent expiry date: 2032-06-22 | drug product |
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 · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.