FDA Orange Book · active-ingredient family
Tucatinib
Tucatinib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TUKYSA · NDA 213411
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TUKYSARLD×2 | SEAGEN | NDA 213411 | — | Apr 17, 2020 |
Marketing exclusivity (6)
- I-906New indication exclusivity (3 years)
Jan 19, 2026
5 mo ago
- ODE-309Orphan-drug exclusivity (7 years)
Apr 17, 2027
in 10 mo
- ODE-422Orphan-drug exclusivity (7 years)
Jan 19, 2030
in 3 yr 8 mo
- I-906New indication exclusivity (3 years)
Jan 19, 2026
5 mo ago
- ODE-309Orphan-drug exclusivity (7 years)
Apr 17, 2027
in 10 mo
- ODE-422Orphan-drug exclusivity (7 years)
Jan 19, 2030
in 3 yr 8 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9693989 | May 09, 2027 | in 11 mo | ProductU-2788 |
| 9457093 | Oct 12, 2032 | in 6 yr 5 mo | ProductU-2788 |
| 11504370 | Mar 25, 2033 | in 6 yr 10 mo | U-2788 |
| 8648087 | Apr 17, 2034 | in 7 yr 11 mo | SubstanceProduct |
| 11666572 | Apr 27, 2038 | in 12 yr | U-3783 |
| 12048698 | Apr 27, 2038 | in 12 yr | U-3783 |
| 11207324 | Apr 27, 2038 | in 12 yr | U-3783 |
Tucatinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
