FDA Orange Book
Is there a generic for Koselugo?
Koselugo contains selumetinib. 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 Koselugo (selumetinib). The Orange Book shows its last listed patent expires March 26, 2029 and its last listed exclusivity ends November 19, 2032.
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Koselugo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
| granule, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
| granule, oral | EQ 7.5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 213756, 219943, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Koselugo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8178693 | March 13, 2026 | Drug substance, Drug product | None | 213756 |
| 9562017 | December 12, 2026 | Drug substance | U-4357 | 213756 |
| 9156795 | December 12, 2026 | Drug substance, Drug product | None | 213756 |
| 7425637 | March 13, 2028 | Drug substance | None | 213756 |
| 12364684 | March 26, 2029 | Method of use | U-4357 | 213756 |
| 11813246 | March 26, 2029 | Drug product | None | 213756 |
| 12318367 | March 26, 2029 | Drug product | None | 213756 |
| 12220403 | March 26, 2029 | Drug product | None | 213756 |
Koselugo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-288 | Orphan drug exclusivity | April 10, 2027 | 213756 |
| ODE* | See the Orange Book exclusivity code list | April 10, 2027 | 219943 |
| NPP | New patient population | September 10, 2028 | 213756 |
| NP | New product | September 10, 2028 | 219943 |
| NPP | New patient population | November 19, 2028 | 213756 |
| ODE-545 | Orphan drug exclusivity | November 19, 2032 | 213756 |
| ODE* | See the Orange Book exclusivity code list | November 19, 2032 | 219943 |
Koselugo NDC codes
Questions
Is there a generic for Koselugo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Koselugo (selumetinib). The Orange Book shows its last listed patent expires March 26, 2029 and its last listed exclusivity ends November 19, 2032.
What is the generic name for Koselugo?
The active ingredient in Koselugo is selumetinib, per the FDA Orange Book.
When does the Koselugo patent expire?
The last patent listed for Koselugo in the Orange Book expires March 26, 2029. 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.