Orange Book product · Brand (NDA)
SCEMBLIX
ASCIMINIB HYDROCHLORIDE
At a glance
Oct 29, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2021
4 yr 8 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Oct 29, 2026
in 4 mo
Exclusivity ends · I-953
New indication exclusivity (3 years)
Oct 29, 2027
in 1 yr 5 mo
Exclusivity ends · I-954
New indication exclusivity (3 years)
Oct 29, 2027
in 1 yr 5 mo
Exclusivity ends · M-318
New use / labeling-change exclusivity (3 years)
Oct 02, 2028
in 2 yr 4 mo
Exclusivity ends · ODE-381
Orphan-drug exclusivity (7 years)
Oct 29, 2028
in 2 yr 5 mo
Exclusivity ends · ODE-382
Orphan-drug exclusivity (7 years)
Oct 29, 2028
in 2 yr 5 mo
Exclusivity ends · ODE-499
Orphan-drug exclusivity (7 years)
Oct 29, 2031
in 5 yr 5 mo
Exclusivity ends · ODE-500
Orphan-drug exclusivity (7 years)
Oct 29, 2031
in 5 yr 5 mo
Patent 8829195 expires
Listed drug substance patent expiration.
Oct 29, 2035
in 9 yr 6 mo
Patent 11407735 expires
Listed drug substance patent expiration.
May 14, 2040
in 14 yr 1 mo
Patent 12252478 expires
Listed drug product patent expiration.
May 14, 2040
in 14 yr 1 mo
Patent 12252479 expires
Listed method-of-use patent (U-1374) expiration.
May 17, 2040
in 14 yr 1 mo
Pharmaceutical detail
Active ingredient
ASCIMINIB HYDROCHLORIDE
Strength
EQ 20MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215358
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 (8)
- NCENew chemical entity exclusivity (5 years)
Oct 29, 2026
in 4 mo
- I-953New indication exclusivity (3 years)
Oct 29, 2027
in 1 yr 5 mo
- I-954New indication exclusivity (3 years)
Oct 29, 2027
in 1 yr 5 mo
- M-318New use / labeling-change exclusivity (3 years)
Oct 02, 2028
in 2 yr 4 mo
- ODE-381Orphan-drug exclusivity (7 years)
Oct 29, 2028
in 2 yr 5 mo
- ODE-382Orphan-drug exclusivity (7 years)
Oct 29, 2028
in 2 yr 5 mo
- ODE-499Orphan-drug exclusivity (7 years)
Oct 29, 2031
in 5 yr 5 mo
- ODE-500Orphan-drug exclusivity (7 years)
Oct 29, 2031
in 5 yr 5 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8829195 | Oct 29, 2035 | in 9 yr 6 mo | SubstanceU-1374 |
| 11407735 | May 14, 2040 | in 14 yr 1 mo | Substance |
| 12252478 | May 14, 2040 | in 14 yr 1 mo | Product |
| 12252479 | May 17, 2040 | in 14 yr 1 mo | U-1374 |
