FDA Orange Book · active-ingredient family
Repotrectinib
Repotrectinib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AUGTYRO · NDA 218213
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
6
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AUGTYRORLD×2 | BRISTOL | NDA 218213 | — | Nov 15, 2023 |
Marketing exclusivity (6)
- NCENew chemical entity exclusivity (5 years)
Nov 15, 2028
in 2 yr 5 mo
- ODE-455Orphan-drug exclusivity (7 years)
Nov 15, 2030
in 4 yr 6 mo
- ODE-483Orphan-drug exclusivity (7 years)
Jun 13, 2031
in 5 yr 1 mo
- NCENew chemical entity exclusivity (5 years)
Nov 15, 2028
in 2 yr 5 mo
- ODE*FDA marketing exclusivity
Nov 15, 2030
in 4 yr 6 mo
- ODE-483Orphan-drug exclusivity (7 years)
Jun 13, 2031
in 5 yr 1 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE50634 | Jan 23, 2035 | in 8 yr 9 mo | SubstanceProduct |
| 10294242 | Jul 05, 2036 | in 10 yr 2 mo | Substance |
| 12187739 | Jul 05, 2036 | in 10 yr 2 mo | Product |
| 12310968 | Jul 20, 2036 | in 10 yr 3 mo | U-3755 |
| 11452725 | Jul 24, 2036 | in 10 yr 3 mo | U-3961 |
Repotrectinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
