# RINVOQ — FDA application NDA211675

Informational only - not investment advice.

Application NDA211675 · type NDA · FDA status: approved · original approval 2019-08-16

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · 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 |

## Orange Book patent and exclusivity listings

- Patent 8962629, product 001; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 001; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 001; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 001; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 001; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 001; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 001; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 002; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 002; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 003; listed patent expiry date: 2031-01-15.
- Patent 8962629, product 003; listed patent expiry date: 2031-01-15.
- Patent RE47221, product 001; listed patent expiry date: 2033-08-16.
- Patent RE47221, product 002; listed patent expiry date: 2033-08-16.
- Patent RE47221, product 003; listed patent expiry date: 2033-08-16.
- Patent 10202393, product 003; listed patent expiry date: 2036-10-17.
- Patent 10344036, product 002; listed patent expiry date: 2036-10-17.
- Patent 10519164, product 001; listed patent expiry date: 2036-10-17.
- Patent 10550126, product 002; listed patent expiry date: 2036-10-17.
- Patent 10597400, product 001; listed patent expiry date: 2036-10-17.
- Patent 10730883, product 002; listed patent expiry date: 2036-10-17.
- Patent 10981923, product 001; listed patent expiry date: 2036-10-17.
- Patent 10981923, product 002; listed patent expiry date: 2036-10-17.
- Patent 10981923, product 003; listed patent expiry date: 2036-10-17.
- Patent 10981924, product 001; listed patent expiry date: 2036-10-17.
- Patent 10981924, product 002; listed patent expiry date: 2036-10-17.
- Patent 10995095, product 001; listed patent expiry date: 2036-10-17.
- Patent 11186584, product 001; listed patent expiry date: 2036-10-17.
- Patent 11186584, product 002; listed patent expiry date: 2036-10-17.
- Patent 11186584, product 003; listed patent expiry date: 2036-10-17.
- Patent 11198697, product 001; listed patent expiry date: 2036-10-17.
- Patent 11198697, product 002; listed patent expiry date: 2036-10-17.
- Patent 11198697, product 003; listed patent expiry date: 2036-10-17.
- Patent 11365198, product 001; listed patent expiry date: 2036-10-17.
- Patent 11365198, product 001; listed patent expiry date: 2036-10-17.
- Patent 11512092, product 001; listed patent expiry date: 2036-10-17.
- Patent 11512092, product 001; listed patent expiry date: 2036-10-17.
- Patent 11512092, product 001; listed patent expiry date: 2036-10-17.
- Patent 11512092, product 001; listed patent expiry date: 2036-10-17.
- Patent 11524964, product 001; listed patent expiry date: 2036-10-17.
- Patent 11535624, product 001; listed patent expiry date: 2036-10-17.
- Patent 11535625, product 001; listed patent expiry date: 2036-10-17.
- Patent 11535626, product 002; listed patent expiry date: 2036-10-17.
- Patent 11661425, product 001; listed patent expiry date: 2036-10-17.
- Patent 11661425, product 002; listed patent expiry date: 2036-10-17.
- Patent 11661425, product 003; listed patent expiry date: 2036-10-17.
- Patent 11680069, product 001; listed patent expiry date: 2036-10-17.
- Patent 11680069, product 002; listed patent expiry date: 2036-10-17.
- Patent 11680069, product 003; listed patent expiry date: 2036-10-17.
- Patent 11718627, product 001; listed patent expiry date: 2036-10-17.
- Patent 11718627, product 002; listed patent expiry date: 2036-10-17.
- Patent 11718627, product 003; listed patent expiry date: 2036-10-17.
- Patent 11767326, product 001; listed patent expiry date: 2036-10-17.
- Patent 11767326, product 002; listed patent expiry date: 2036-10-17.
- Patent 11773105, product 001; listed patent expiry date: 2036-10-17.
- Patent 11773105, product 002; listed patent expiry date: 2036-10-17.
- Patent 11773105, product 003; listed patent expiry date: 2036-10-17.
- Patent 11773106, product 001; listed patent expiry date: 2036-10-17.
- Patent 11773106, product 001; listed patent expiry date: 2036-10-17.
- Patent 11773106, product 001; listed patent expiry date: 2036-10-17.
- Patent 11773106, product 001; listed patent expiry date: 2036-10-17.
- Patent 11780847, product 001; listed patent expiry date: 2036-10-17.
- Patent 11780848, product 001; listed patent expiry date: 2036-10-17.
- Patent 11787815, product 001; listed patent expiry date: 2036-10-17.
- Patent 11795175, product 001; listed patent expiry date: 2036-10-17.
- Patent 11976077, product 001; listed patent expiry date: 2036-10-17.
- Patent 11993605, product 001; listed patent expiry date: 2036-10-17.
- Patent 11993605, product 001; listed patent expiry date: 2036-10-17.
- Patent 11993606, product 001; listed patent expiry date: 2036-10-17.
- Patent 12077545, product 001; listed patent expiry date: 2036-10-17.
- Patent 12077545, product 002; listed patent expiry date: 2036-10-17.
- Patent 12077545, product 003; listed patent expiry date: 2036-10-17.
- Patent 12091415, product 002; listed patent expiry date: 2036-10-17.
- Patent 12103933, product 001; listed patent expiry date: 2036-10-17.
- Patent 12110297, product 001; listed patent expiry date: 2036-10-17.
- Patent 12110298, product 001; listed patent expiry date: 2036-10-17.
- Patent 12110298, product 002; listed patent expiry date: 2036-10-17.
- Patent 12110298, product 003; listed patent expiry date: 2036-10-17.
- Patent 12116373, product 002; listed patent expiry date: 2036-10-17.
- Patent 12134621, product 003; listed patent expiry date: 2036-10-17.
- Patent 12365689, product 001; listed patent expiry date: 2036-10-17.
- Patent 12570664, product 001; listed patent expiry date: 2036-10-17.
- Patent 9951080, product 001; listed patent expiry date: 2036-10-17.
- Patent 9951080, product 002; listed patent expiry date: 2036-10-17.
- Patent 9951080, product 003; listed patent expiry date: 2036-10-17.
- Patent 9963459, product 001; listed patent expiry date: 2036-10-17.
- Patent 11564922, product 001; listed patent expiry date: 2038-03-09.
- Patent 11564922, product 001; listed patent expiry date: 2038-03-09.
- Patent 11564922, product 002; listed patent expiry date: 2038-03-09.
- Patent 11564922, product 002; listed patent expiry date: 2038-03-09.
- Patent 11564922, product 003; listed patent expiry date: 2038-03-09.
- Patent 11564922, product 003; listed patent expiry date: 2038-03-09.
- Patent 11607411, product 001; listed patent expiry date: 2038-03-09.
- Patent 11607411, product 001; listed patent expiry date: 2038-03-09.
- Patent 11607411, product 002; listed patent expiry date: 2038-03-09.
- Patent 11607411, product 002; listed patent expiry date: 2038-03-09.
- Patent 11607411, product 003; listed patent expiry date: 2038-03-09.
- Patent 11607411, product 003; listed patent expiry date: 2038-03-09.
- Exclusivity I-919, product 001; listed exclusivity date: 2026-05-18.
- Exclusivity I-919, product 002; listed exclusivity date: 2026-05-18.
- Exclusivity I-919, product 003; listed exclusivity date: 2026-05-18.
- Exclusivity I-946, product 001; listed exclusivity date: 2027-04-26.
- Exclusivity I-946, product 002; listed exclusivity date: 2027-04-26.
- Exclusivity I-946, product 003; listed exclusivity date: 2027-04-26.
- Exclusivity NPP, product 001; listed exclusivity date: 2027-04-26.
- Exclusivity NPP, product 002; listed exclusivity date: 2027-04-26.
- Exclusivity NPP, product 003; listed exclusivity date: 2027-04-26.
- Exclusivity I-966, product 001; listed exclusivity date: 2028-04-28.
- Exclusivity ODE-481, product 001; listed exclusivity date: 2031-04-26.
- Exclusivity ODE-481, product 002; listed exclusivity date: 2031-04-26.
- Exclusivity ODE-481, product 003; listed exclusivity date: 2031-04-26.
- Exclusivity ODE-538, product 001; listed exclusivity date: 2032-04-28.

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](/company/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

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:NDA211675. FDA data retrieved 2026-08-07.

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