RINVOQ — FDA application NDA211675
Listed sponsor: ABBVIE · ABBV 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 | RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE | ORAL | 15MG | Prescription | not listed | Yes |
| 002 | RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE | ORAL | 30MG | Prescription | not listed | Yes |
| 003 | RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE | ORAL | 45MG | 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 8962629 | 001 | listed patent expiry date: 2031-01-15 | drug substance, U-3371 |
| Patent 8962629 | 001 | listed patent expiry date: 2031-01-15 | drug substance, U-3624 |
| Patent 8962629 | 001 | listed patent expiry date: 2031-01-15 | drug substance, U-3946 |
| Patent 8962629 | 001 | listed patent expiry date: 2031-01-15 | drug substance, U-3945 |
| Patent 8962629 | 001 | listed patent expiry date: 2031-01-15 | drug substance, U-3275 |
| Patent 8962629 | 001 | listed patent expiry date: 2031-01-15 | drug substance, U-3255 |
| Patent 8962629 | 001 | listed patent expiry date: 2031-01-15 | drug substance, U-3341 |
| Patent 8962629 | 002 | listed patent expiry date: 2031-01-15 | drug substance, U-3624 |
| Patent 8962629 | 002 | listed patent expiry date: 2031-01-15 | drug substance, U-3341 |
| Patent 8962629 | 003 | listed patent expiry date: 2031-01-15 | drug substance, U-3624 |
| Patent 8962629 | 003 | listed patent expiry date: 2031-01-15 | drug substance, U-3341 |
| Patent RE47221 | 001 | listed patent expiry date: 2033-08-16 | drug substance |
| Patent RE47221 | 002 | listed patent expiry date: 2033-08-16 | drug substance |
| Patent RE47221 | 003 | listed patent expiry date: 2033-08-16 | drug substance |
| Patent 10202393 | 003 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 10344036 | 002 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 10519164 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 10550126 | 002 | listed patent expiry date: 2036-10-17 | U-3298 |
| Patent 10597400 | 001 | listed patent expiry date: 2036-10-17 | U-3255 |
| Patent 10730883 | 002 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 10981923 | 001 | listed patent expiry date: 2036-10-17 | drug substance |
| Patent 10981923 | 002 | listed patent expiry date: 2036-10-17 | drug substance |
| Patent 10981923 | 003 | listed patent expiry date: 2036-10-17 | drug substance |
| Patent 10981924 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 10981924 | 002 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 10995095 | 001 | listed patent expiry date: 2036-10-17 | U-3298 |
| Patent 11186584 | 001 | listed patent expiry date: 2036-10-17 | drug substance |
| Patent 11186584 | 002 | listed patent expiry date: 2036-10-17 | drug substance |
| Patent 11186584 | 003 | listed patent expiry date: 2036-10-17 | drug substance |
| Patent 11198697 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 11198697 | 002 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 11198697 | 003 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 11365198 | 001 | listed patent expiry date: 2036-10-17 | U-3946 |
| Patent 11365198 | 001 | listed patent expiry date: 2036-10-17 | U-3275 |
| Patent 11512092 | 001 | listed patent expiry date: 2036-10-17 | U-3946 |
| Patent 11512092 | 001 | listed patent expiry date: 2036-10-17 | U-3275 |
| Patent 11512092 | 001 | listed patent expiry date: 2036-10-17 | U-3487 |
| Patent 11512092 | 001 | listed patent expiry date: 2036-10-17 | U-3371 |
| Patent 11524964 | 001 | listed patent expiry date: 2036-10-17 | U-3371 |
| Patent 11535624 | 001 | listed patent expiry date: 2036-10-17 | U-3255 |
| Patent 11535625 | 001 | listed patent expiry date: 2036-10-17 | U-3298 |
| Patent 11535626 | 002 | listed patent expiry date: 2036-10-17 | U-3298 |
| Patent 11661425 | 001 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11661425 | 002 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11661425 | 003 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11680069 | 001 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11680069 | 002 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11680069 | 003 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11718627 | 001 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11718627 | 002 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11718627 | 003 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11767326 | 001 | listed patent expiry date: 2036-10-17 | U-3298 |
| Patent 11767326 | 002 | listed patent expiry date: 2036-10-17 | U-3298 |
| Patent 11773105 | 001 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11773105 | 002 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11773105 | 003 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 11773106 | 001 | listed patent expiry date: 2036-10-17 | U-3946 |
| Patent 11773106 | 001 | listed patent expiry date: 2036-10-17 | U-3275 |
| Patent 11773106 | 001 | listed patent expiry date: 2036-10-17 | U-3487 |
| Patent 11773106 | 001 | listed patent expiry date: 2036-10-17 | U-3371 |
| Patent 11780847 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 11780848 | 001 | listed patent expiry date: 2036-10-17 | U-3371 |
| Patent 11787815 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 11795175 | 001 | listed patent expiry date: 2036-10-17 | U-3255 |
| Patent 11976077 | 001 | listed patent expiry date: 2036-10-17 | U-3298 |
| Patent 11993605 | 001 | listed patent expiry date: 2036-10-17 | U-3275 |
| Patent 11993605 | 001 | listed patent expiry date: 2036-10-17 | U-3946 |
| Patent 11993606 | 001 | listed patent expiry date: 2036-10-17 | U-3487 |
| Patent 12077545 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12077545 | 002 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12077545 | 003 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12091415 | 002 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12103933 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12110297 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12110298 | 001 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 12110298 | 002 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 12110298 | 003 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 12116373 | 002 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12134621 | 003 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 12365689 | 001 | listed patent expiry date: 2036-10-17 | U-3945 |
| Patent 12570664 | 001 | listed patent expiry date: 2036-10-17 | U-4454 |
| Patent 9951080 | 001 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 9951080 | 002 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 9951080 | 003 | listed patent expiry date: 2036-10-17 | drug substance, drug product |
| Patent 9963459 | 001 | listed patent expiry date: 2036-10-17 | drug product |
| Patent 11564922 | 001 | listed patent expiry date: 2038-03-09 | U-4303 |
| Patent 11564922 | 001 | listed patent expiry date: 2038-03-09 | U-3624 |
| Patent 11564922 | 002 | listed patent expiry date: 2038-03-09 | U-4303 |
| Patent 11564922 | 002 | listed patent expiry date: 2038-03-09 | U-3624 |
| Patent 11564922 | 003 | listed patent expiry date: 2038-03-09 | U-4303 |
| Patent 11564922 | 003 | listed patent expiry date: 2038-03-09 | U-3624 |
| Patent 11607411 | 001 | listed patent expiry date: 2038-03-09 | U-4302 |
| Patent 11607411 | 001 | listed patent expiry date: 2038-03-09 | U-3341 |
| Patent 11607411 | 002 | listed patent expiry date: 2038-03-09 | U-4302 |
| Patent 11607411 | 002 | listed patent expiry date: 2038-03-09 | U-3341 |
| Patent 11607411 | 003 | listed patent expiry date: 2038-03-09 | U-4302 |
| Patent 11607411 | 003 | listed patent expiry date: 2038-03-09 | U-3341 |
| Exclusivity I-919 | 001 | listed exclusivity date: 2026-05-18 | FDA code as listed |
| Exclusivity I-919 | 002 | listed exclusivity date: 2026-05-18 | FDA code as listed |
| Exclusivity I-919 | 003 | listed exclusivity date: 2026-05-18 | FDA code as listed |
| Exclusivity I-946 | 001 | listed exclusivity date: 2027-04-26 | FDA code as listed |
| Exclusivity I-946 | 002 | listed exclusivity date: 2027-04-26 | FDA code as listed |
| Exclusivity I-946 | 003 | listed exclusivity date: 2027-04-26 | FDA code as listed |
| Exclusivity NPP | 001 | listed exclusivity date: 2027-04-26 | FDA code as listed |
| Exclusivity NPP | 002 | listed exclusivity date: 2027-04-26 | FDA code as listed |
| Exclusivity NPP | 003 | listed exclusivity date: 2027-04-26 | FDA code as listed |
| Exclusivity I-966 | 001 | listed exclusivity date: 2028-04-28 | FDA code as listed |
| Exclusivity ODE-481 | 001 | listed exclusivity date: 2031-04-26 | FDA code as listed |
| Exclusivity ODE-481 | 002 | listed exclusivity date: 2031-04-26 | FDA code as listed |
| Exclusivity ODE-481 | 003 | listed exclusivity date: 2031-04-26 | FDA code as listed |
| Exclusivity ODE-538 | 001 | listed exclusivity date: 2032-04-28 | 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
- UPADACITINIB · UNII 4RA0KN46E0 · 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.