FDA Orange Book · active-ingredient family
Upadacitinib
Upadacitinib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:RINVOQ LQ · NDA 218347
2
Brand (NDA)
0
Generics (ANDA)
45
Listed patents
16
Exclusivity periods
Brand (NDA) products · solution, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RINVOQ LQRLD | ABBVIE | NDA 218347 | — | Apr 26, 2024 | |
| RINVOQRLD×3 | ABBVIE | NDA 211675 | — | Aug 16, 2019 |
Marketing exclusivity (16)
- NPNew product exclusivity (3 years)
Apr 26, 2027
in 10 mo
- ODE-481Orphan-drug exclusivity (7 years)
Apr 26, 2031
in 4 yr 11 mo
- I-919New indication exclusivity (3 years)
May 18, 2026
1 mo ago
- I-946New indication exclusivity (3 years)
Apr 26, 2027
in 10 mo
- I-966New indication exclusivity (3 years)
Apr 28, 2028
in 1 yr 11 mo
- NPPNew patient population exclusivity (3 years)
Apr 26, 2027
in 10 mo
- ODE-481Orphan-drug exclusivity (7 years)
Apr 26, 2031
in 4 yr 11 mo
- ODE-538Orphan-drug exclusivity (7 years)
Apr 28, 2032
in 5 yr 11 mo
- I-919New indication exclusivity (3 years)
May 18, 2026
1 mo ago
- I-946New indication exclusivity (3 years)
Apr 26, 2027
in 10 mo
- NPPNew patient population exclusivity (3 years)
Apr 26, 2027
in 10 mo
- ODE-481Orphan-drug exclusivity (7 years)
Apr 26, 2031
in 4 yr 11 mo
- I-919New indication exclusivity (3 years)
May 18, 2026
1 mo ago
- I-946New indication exclusivity (3 years)
Apr 26, 2027
in 10 mo
- NPPNew patient population exclusivity (3 years)
Apr 26, 2027
in 10 mo
- ODE-481Orphan-drug exclusivity (7 years)
Apr 26, 2031
in 4 yr 11 mo
Listed patents (45)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8962629 | Jan 15, 2031 | in 4 yr 8 mo | SubstanceU-3946 |
| RE47221 | Aug 16, 2033 | in 7 yr 3 mo | Substance |
| 12365689 | Oct 17, 2036 | in 10 yr 6 mo | U-3945 |
| 9951080 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 10981923 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11680069 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 12110298 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11718627 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11661425 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11773105 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11186584 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11512092 | Oct 17, 2036 | in 10 yr 6 mo | U-3946 |
| 11365198 | Oct 17, 2036 | in 10 yr 6 mo | U-3946 |
| 11773106 | Oct 17, 2036 | in 10 yr 6 mo | U-3946 |
| 11976077 | Oct 17, 2036 | in 10 yr 6 mo | U-3298 |
| 11524964 | Oct 17, 2036 | in 10 yr 6 mo | U-3371 |
| 11795175 | Oct 17, 2036 | in 10 yr 6 mo | U-3255 |
| 11535624 | Oct 17, 2036 | in 10 yr 6 mo | U-3255 |
| 11535625 | Oct 17, 2036 | in 10 yr 6 mo | U-3298 |
| 11993605 | Oct 17, 2036 | in 10 yr 6 mo | U-3275 |
| 11993606 | Oct 17, 2036 | in 10 yr 6 mo | U-3487 |
| 11767326 | Oct 17, 2036 | in 10 yr 6 mo | U-3298 |
| 10995095 | Oct 17, 2036 | in 10 yr 6 mo | U-3298 |
| 10597400 | Oct 17, 2036 | in 10 yr 6 mo | U-3255 |
| 11780848 | Oct 17, 2036 | in 10 yr 6 mo | U-3371 |
| 12570664 | Oct 17, 2036 | in 10 yr 6 mo | U-4454 |
| 11198697 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 12103933 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 10981924 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 11787815 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 12077545 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 11780847 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 9963459 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 12110297 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 10519164 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 10550126 | Oct 17, 2036 | in 10 yr 6 mo | U-3298 |
| 11535626 | Oct 17, 2036 | in 10 yr 6 mo | U-3298 |
| 12091415 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 10344036 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 12116373 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 10730883 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 10202393 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 12134621 | Oct 17, 2036 | in 10 yr 6 mo | Product |
| 11607411 | Mar 09, 2038 | in 11 yr 11 mo | U-4302 |
| 11564922 | Mar 09, 2038 | in 11 yr 11 mo | U-4303 |
Upadacitinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
