Orange Book product · Brand (NDA)
ROZLYTREK
ENTRECTINIB
At a glance
Oct 20, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 2023
2 yr 8 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
Aug 15, 2026
in 2 mo
Exclusivity ends · ODE*
FDA marketing exclusivity
Aug 15, 2026
in 2 mo
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 20, 2026
in 4 mo
Exclusivity ends · ODE-448
Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
Pharmaceutical detail
Active ingredient
ENTRECTINIB
Strength
50MG/PACKET
Dosage form
PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 218550
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 (4)
- ODE*FDA marketing exclusivity
Aug 15, 2026
in 2 mo
- ODE*FDA marketing exclusivity
Aug 15, 2026
in 2 mo
- NPNew product exclusivity (3 years)
Oct 20, 2026
in 4 mo
- ODE-448Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
