FDA Orange Book · active-ingredient family
Asciminib hydrochloride
Asciminib hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
19
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SCEMBLIXRLD×3 | NOVARTIS | NDA 215358 | — | Oct 29, 2021 |
Marketing exclusivity (19)
- 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
- NCENew chemical entity exclusivity (5 years)
Oct 29, 2026
in 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
- 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
- NCENew chemical entity exclusivity (5 years)
Oct 29, 2026
in 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
- M-318New use / labeling-change exclusivity (3 years)
Oct 02, 2028
in 2 yr 4 mo
- NCENew chemical entity exclusivity (5 years)
Oct 29, 2026
in 4 mo
- ODE*FDA marketing exclusivity
Oct 29, 2028
in 2 yr 5 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8829195 | Oct 29, 2035 | in 9 yr 6 mo | SubstanceU-1374 |
| 12252478 | May 14, 2040 | in 14 yr 1 mo | Product |
| 11407735 | May 14, 2040 | in 14 yr 1 mo | Substance |
| 12252479 | May 17, 2040 | in 14 yr 1 mo | U-1374 |
Asciminib hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
