FDA Orange Book
Is there a generic for Scemblix?
Scemblix contains asciminib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Scemblix (asciminib). The Orange Book shows its last listed patent expires May 17, 2040 and its last listed exclusivity ends October 29, 2031.
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Scemblix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | None | 0 | None |
NDA 215358, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Scemblix patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8829195 | October 29, 2035 | Drug substance | U-1374 | 215358 |
| 12252478 | May 14, 2040 | Drug product | None | 215358 |
| 11407735 | May 14, 2040 | Drug substance | None | 215358 |
| 12252479 | May 17, 2040 | Method of use | U-1374 | 215358 |
Scemblix exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 29, 2026 | 215358 |
| I-953 | New indication | October 29, 2027 | 215358 |
| I-954 | New indication | October 29, 2027 | 215358 |
| M-318 | Miscellaneous | October 2, 2028 | 215358 |
| ODE-381 | Orphan drug exclusivity | October 29, 2028 | 215358 |
| ODE-382 | Orphan drug exclusivity | October 29, 2028 | 215358 |
| ODE* | See the Orange Book exclusivity code list | October 29, 2028 | 215358 |
| ODE-499 | Orphan drug exclusivity | October 29, 2031 | 215358 |
| ODE-500 | Orphan drug exclusivity | October 29, 2031 | 215358 |
Scemblix NDC codes
Questions
Is there a generic for Scemblix?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Scemblix (asciminib). The Orange Book shows its last listed patent expires May 17, 2040 and its last listed exclusivity ends October 29, 2031.
What is the generic name for Scemblix?
The active ingredient in Scemblix is asciminib, per the FDA Orange Book.
When does the Scemblix patent expire?
The last patent listed for Scemblix in the Orange Book expires May 17, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.