FDA Orange Book
Is there a generic for Iclusig?
Iclusig contains ponatinib. 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 Iclusig (ponatinib). The Orange Book shows its last listed patent expires December 12, 2033 and its last listed exclusivity ends March 19, 2031.
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Iclusig products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 15MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 30MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 45MG BASE | Marketed (Rx) | None | 0 | None |
NDA 203469, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Iclusig patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9029533 | December 22, 2026 | Method of use | U-1701 | 203469 |
| 9029533 | December 22, 2026 | Method of use | U-1700 | 203469 |
| 9029533 | December 22, 2026 | Method of use | U-836 | 203469 |
| 9029533 | December 22, 2026 | Method of use | U-1283 | 203469 |
| 9029533 | December 22, 2026 | Method of use | U-1699 | 203469 |
| 8114874 | January 24, 2027 | Drug substance, Drug product | None | 203469 |
| 9493470 | December 12, 2033 | Drug substance, Drug product | U-1948 | 203469 |
| 9493470 | December 12, 2033 | Drug substance, Drug product | U-1700 | 203469 |
| 11384086 | December 12, 2033 | Drug substance, Drug product | U-1948 | 203469 |
| 11384086 | December 12, 2033 | Drug substance, Drug product | U-1701 | 203469 |
| 11384086 | December 12, 2033 | Drug substance, Drug product | U-1700 | 203469 |
| 11192897 | December 12, 2033 | Drug substance | U-1700 | 203469 |
| 11192897 | December 12, 2033 | Drug substance | U-1701 | 203469 |
| 11192897 | December 12, 2033 | Drug substance | U-1948 | 203469 |
| 11192895 | December 12, 2033 | Method of use | U-1700 | 203469 |
| 11192895 | December 12, 2033 | Method of use | U-1701 | 203469 |
| 11192895 | December 12, 2033 | Method of use | U-1948 | 203469 |
Iclusig exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-934 | New indication | March 19, 2027 | 203469 |
| ODE-472 | Orphan drug exclusivity | March 19, 2031 | 203469 |
Iclusig NDC codes
Questions
Is there a generic for Iclusig?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Iclusig (ponatinib). The Orange Book shows its last listed patent expires December 12, 2033 and its last listed exclusivity ends March 19, 2031.
What is the generic name for Iclusig?
The active ingredient in Iclusig is ponatinib, per the FDA Orange Book.
When does the Iclusig patent expire?
The last patent listed for Iclusig in the Orange Book expires December 12, 2033. 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.