FDA Orange Book · active-ingredient family
Sotorasib
Sotorasib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:LUMAKRAS · NDA 214665
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
12
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUMAKRASRLD×3 | AMGEN INC | NDA 214665 | — | May 28, 2021 |
Marketing exclusivity (12)
- I-962New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
- NCENew chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
- ODE-352Orphan-drug exclusivity (7 years)
May 28, 2028
in 2 yr
- ODE-507Orphan-drug exclusivity (7 years)
Jan 16, 2032
in 5 yr 8 mo
- I-962New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
- NCENew chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
- ODE*FDA marketing exclusivity
May 28, 2028
in 2 yr
- ODE-507Orphan-drug exclusivity (7 years)
Jan 16, 2032
in 5 yr 8 mo
- I-962New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
- NCENew chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
- ODE-352Orphan-drug exclusivity (7 years)
May 28, 2028
in 2 yr
- ODE-507Orphan-drug exclusivity (7 years)
Jan 16, 2032
in 5 yr 8 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10519146 | May 21, 2038 | in 12 yr 1 mo | SubstanceProduct |
| 12280056 | Nov 18, 2039 | in 13 yr 7 mo | U-4107 |
| 12398133 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-3306 |
| 11236091 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-4107 |
| 11827635 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-4107 |
| 11426404 | Sep 15, 2040 | in 14 yr 5 mo | U-3306 |
Sotorasib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
