Orange Book product · Brand (NDA)
LUMAKRAS
SOTORASIB
At a glance
May 28, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2021
5 yr 2 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
Today
Exclusivity ends · I-962
New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
Exclusivity ends · ODE-352
Orphan-drug exclusivity (7 years)
May 28, 2028
in 2 yr
Exclusivity ends · ODE-507
Orphan-drug exclusivity (7 years)
Jan 16, 2032
in 5 yr 8 mo
Patent 10519146 expires
Listed drug substance patent expiration.
May 21, 2038
in 12 yr 1 mo
Patent 12280056 expires
Listed method-of-use patent (U-4107) expiration.
Nov 18, 2039
in 13 yr 7 mo
Patent 11236091 expires
Listed drug substance patent expiration.
May 20, 2040
in 14 yr 1 mo
Patent 11236091 expires
Listed drug substance patent expiration.
May 20, 2040
in 14 yr 1 mo
Patent 11827635 expires
Listed drug substance patent expiration.
May 20, 2040
in 14 yr 1 mo
Patent 11827635 expires
Listed drug substance patent expiration.
May 20, 2040
in 14 yr 1 mo
Patent 12398133 expires
Listed drug substance patent expiration.
May 20, 2040
in 14 yr 1 mo
Patent 12398133 expires
Listed drug substance patent expiration.
May 20, 2040
in 14 yr 1 mo
Patent 11426404 expires
Listed method-of-use patent (U-3306) expiration.
Sep 15, 2040
in 14 yr 5 mo
Patent 11426404 expires
Listed method-of-use patent (U-4107) expiration.
Sep 15, 2040
in 14 yr 5 mo
Pharmaceutical detail
Active ingredient
SOTORASIB
Strength
120MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214665
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
- NCENew chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
- I-962New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
- 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 (10)
| 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 |
| 11236091 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-4107 |
| 11236091 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-3306 |
| 11827635 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-4107 |
| 11827635 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-3306 |
| 12398133 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-3306 |
| 12398133 | May 20, 2040 | in 14 yr 1 mo | SubstanceProductU-4107 |
| 11426404 | Sep 15, 2040 | in 14 yr 5 mo | U-3306 |
| 11426404 | Sep 15, 2040 | in 14 yr 5 mo | U-4107 |
