Orange Book product · Brand (NDA)
IBTROZI
TALETRECTINIB ADIPATE
At a glance
Jun 11, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 11, 2025
1 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 11, 2030
in 4 yr
Exclusivity ends · ODE-544
Orphan-drug exclusivity (7 years)
Jun 11, 2032
in 6 yr 1 mo
Patent 9187489 expires
Listed drug substance patent expiration.
Jun 03, 2033
in 7 yr 1 mo
Patent 9751887 expires
Listed drug substance patent expiration.
Jun 03, 2033
in 7 yr 1 mo
Pharmaceutical detail
Active ingredient
TALETRECTINIB ADIPATE
Strength
EQ 200MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 219713
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)
- NCENew chemical entity exclusivity (5 years)
Jun 11, 2030
in 4 yr
- ODE-544Orphan-drug exclusivity (7 years)
Jun 11, 2032
in 6 yr 1 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9187489 | Jun 03, 2033 | in 7 yr 1 mo | SubstanceProductU-4207 |
| 9751887 | Jun 03, 2033 | in 7 yr 1 mo | SubstanceProductU-4207 |
