Orange Book product · Brand (NDA)
RINVOQ LQ
UPADACITINIB
At a glance
Apr 26, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 2024
2 yr 2 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Apr 26, 2027
in 10 mo
Patent 8962629 expires
Listed drug substance patent expiration.
Jan 15, 2031
in 4 yr 8 mo
Patent 8962629 expires
Listed drug substance patent expiration.
Jan 15, 2031
in 4 yr 8 mo
Exclusivity ends · ODE-481
Orphan-drug exclusivity (7 years)
Apr 26, 2031
in 4 yr 11 mo
Patent RE47221 expires
Listed drug substance patent expiration.
Aug 16, 2033
in 7 yr 3 mo
Patent 10981923 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 11186584 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 11661425 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 11680069 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 11718627 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 11773105 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 12110298 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 12365689 expires
Listed method-of-use patent (U-3945) expiration.
Oct 17, 2036
in 10 yr 6 mo
Patent 9951080 expires
Listed drug substance patent expiration.
Oct 17, 2036
in 10 yr 6 mo
Pharmaceutical detail
Active ingredient
UPADACITINIB
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 218347
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- 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
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8962629 | Jan 15, 2031 | in 4 yr 8 mo | SubstanceU-3946 |
| 8962629 | Jan 15, 2031 | in 4 yr 8 mo | SubstanceU-3945 |
| RE47221 | Aug 16, 2033 | in 7 yr 3 mo | Substance |
| 10981923 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11186584 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11661425 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11680069 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11718627 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 11773105 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 12110298 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
| 12365689 | Oct 17, 2036 | in 10 yr 6 mo | U-3945 |
| 9951080 | Oct 17, 2036 | in 10 yr 6 mo | Substance |
