ODEFSEY — FDA application NDA208351
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 | ODEFSEY | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET | ORAL | 200MG;EQ 25MG BASE;EQ 25MG BASE | Prescription | AB | 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 8754065 | 001 | listed patent expiry date: 2032-08-15 | drug substance, drug product, U-257 |
| Patent 9296769 | 001 | listed patent expiry date: 2032-08-15 | drug substance, drug product, U-257 |
| Patent 8754065 | 001 | listed patent expiry date: 2033-02-15 | pediatric extension |
| Patent 9296769 | 001 | listed patent expiry date: 2033-02-15 | pediatric extension |
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
- EMTRICITABINE · UNII G70B4ETF4S · no lmmol compound match
- RILPIVIRINE HYDROCHLORIDE · UNII 212WAX8KDD · no lmmol compound match
- TENOFOVIR ALAFENAMIDE FUMARATE · UNII FWF6Q91TZO · 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: 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.