LIVDELZI — FDA application NDA217899
Listed sponsor: GILEAD SCIENCES INC · GILD 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 | LIVDELZI | SELADELPAR LYSINE | CAPSULE | ORAL | EQ 10MG BASE | 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 7301050 | 001 | listed patent expiry date: 2026-08-02 | drug substance, drug product |
| Patent 7709682 | 001 | listed patent expiry date: 2026-09-13 | drug substance |
| Patent 10272058 | 001 | listed patent expiry date: 2035-03-19 | U-1854 |
| Patent 11406611 | 001 | listed patent expiry date: 2035-03-19 | U-1854 |
| Patent 11596614 | 001 | listed patent expiry date: 2035-03-19 | U-1854 |
| Patent 9486428 | 001 | listed patent expiry date: 2035-03-19 | U-1854 |
| Exclusivity NCE | 001 | listed exclusivity date: 2029-08-14 | FDA code as listed |
| Exclusivity ODE-486 | 001 | listed exclusivity date: 2031-08-14 | FDA code as listed |
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
- SELADELPAR LYSINE · UNII N1429130KR · lmmol compound WTKSWPYGZDCUNQ-JZXFCXSPSA-N · CHEMBL3989960
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: Large-cap biopharma
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.