Orange Book product · Brand (NDA)
KRAZATI
ADAGRASIB
At a glance
Dec 12, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 2022
3 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 12, 2027
in 1 yr 6 mo
Exclusivity ends · ODE-352
Orphan-drug exclusivity (7 years)
Dec 12, 2029
in 3 yr 6 mo
Patent 10689377 expires
Listed drug substance patent expiration.
May 17, 2037
in 11 yr 1 mo
Patent 10689377 expires
Listed drug substance patent expiration.
May 17, 2037
in 11 yr 1 mo
Patent 12336995 expires
Listed method-of-use patent (U-3953) expiration.
Feb 05, 2041
in 14 yr 10 mo
Patent 12281113 expires
Listed drug substance patent expiration.
Sep 10, 2041
in 15 yr 5 mo
Patent 12383503 expires
Listed drug product patent expiration.
Aug 21, 2043
in 17 yr 5 mo
Pharmaceutical detail
Active ingredient
ADAGRASIB
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216340
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 (2)
- NCENew chemical entity exclusivity (5 years)
Dec 12, 2027
in 1 yr 6 mo
- ODE-352Orphan-drug exclusivity (7 years)
Dec 12, 2029
in 3 yr 6 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10689377 | May 17, 2037 | in 11 yr 1 mo | SubstanceProductU-3490 |
| 10689377 | May 17, 2037 | in 11 yr 1 mo | SubstanceProductU-3953 |
| 12336995 | Feb 05, 2041 | in 14 yr 10 mo | U-3953 |
| 12281113 | Sep 10, 2041 | in 15 yr 5 mo | SubstanceProduct |
| 12383503 | Aug 21, 2043 | in 17 yr 5 mo | Product |
