FDA Orange Book · active-ingredient family
Entrectinib
Entrectinib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ROZLYTREK · NDA 218550
2
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
12
Exclusivity periods
Brand (NDA) products · capsule, pellets
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROZLYTREKRLD | GENENTECH INC | NDA 218550 | — | Oct 20, 2023 | |
| ROZLYTREKRLD×2 | GENENTECH INC | NDA 212725 | — | Aug 15, 2019 |
Marketing exclusivity (12)
- NPPNew patient population exclusivity (3 years)
Oct 20, 2026
in 4 mo
- ODE-265Orphan-drug exclusivity (7 years)
Aug 15, 2026
in 2 mo
- ODE-313Orphan-drug exclusivity (7 years)
Aug 15, 2026
in 2 mo
- ODE-448Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
- NPPNew patient population exclusivity (3 years)
Oct 20, 2026
in 4 mo
- ODE-265Orphan-drug exclusivity (7 years)
Aug 15, 2026
in 2 mo
- ODE-313Orphan-drug exclusivity (7 years)
Aug 15, 2026
in 2 mo
- ODE-448Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
- NPNew product exclusivity (3 years)
Oct 20, 2026
in 4 mo
- ODE*FDA marketing exclusivity
Aug 15, 2026
in 2 mo
- ODE*FDA marketing exclusivity
Aug 15, 2026
in 2 mo
- ODE-448Orphan-drug exclusivity (7 years)
Oct 20, 2030
in 4 yr 5 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9616059 | Jul 08, 2028 | in 2 yr 1 mo | U-2618 |
| 8673893 | Jul 08, 2028 | in 2 yr 1 mo | U-2618 |
| 9255087 | Jul 08, 2028 | in 2 yr 1 mo | U-2618 |
| 9029356 | Jul 08, 2028 | in 2 yr 1 mo | SubstanceProduct |
| 9085558 | Jul 08, 2028 | in 2 yr 1 mo | Product |
| 8299057 | Mar 10, 2032 | in 5 yr 10 mo | SubstanceProduct |
| 9649306 | May 22, 2033 | in 7 yr | U-2618 |
| 9085565 | May 22, 2033 | in 7 yr | SubstanceProduct |
| 10231965 | Feb 17, 2035 | in 8 yr 10 mo | U-2618 |
| 10561651 | Feb 19, 2035 | in 8 yr 10 mo | U-2745 |
| 10738037 | May 18, 2037 | in 11 yr 1 mo | SubstanceProductU-2946 |
| 11091469 | May 18, 2037 | in 11 yr 1 mo | U-2617 |
| 11253515 | Jul 18, 2038 | in 12 yr 3 mo | Product |
| 10398693 | Jul 18, 2038 | in 12 yr 3 mo | Product |
Entrectinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
