tucatinib · Seagen · NDA 213411
Tukysa
Earliest generic entry, as listed · earliest of 2 marketed strengths
27 Apr 2038
Blocked by patent: US 11207324, US 11666572, US 12048698. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11207324 | use U-3783 · sets the listed date | 27 Apr 2038 |
| US 11666572 | use U-3783 · sets the listed date | 27 Apr 2038 |
| US 12048698 | use U-3783 · sets the listed date | 27 Apr 2038 |
| US 8648087 | drug substance, drug product | 17 Apr 2034 |
| US 11504370 | use U-2788 | 25 Mar 2033 |
| US 9457093 | drug product, use U-2788 | 12 Oct 2032 |
| US 9693989 | drug product, use U-2788 | 9 May 2027 |
Exclusivities · 2 unexpired
| ODE-422 | orphan drug (7 years) | 19 Jan 2030 |
| ODE-309 | orphan drug (7 years) | 17 Apr 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213411 · 001 · RLD | tablet, oral | 50MG | 27 Apr 2038 |
| 213411 · 002 · RLD | tablet, oral | 150MG | 27 Apr 2038 |
Expired or delisted (1)
- I-906 · 19 Jan 2026