FDA Orange Book
Is there a generic for Skyclarys?
Skyclarys contains omaveloxolone. 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 Skyclarys (omaveloxolone). The Orange Book shows its last listed patent expires April 24, 2033 and its last listed exclusivity ends February 28, 2030.
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Skyclarys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 216718, held by BIOGEN US CORPORATION. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Skyclarys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11091430 | April 20, 2029 | Method of use | U-3552 | 216718 |
| 11919838 | April 20, 2029 | Method of use | U-3862 | 216718 |
| 11919838 | April 20, 2029 | Method of use | U-3863 | 216718 |
| 9670147 | April 20, 2029 | Drug substance | None | 216718 |
| 8440854 | April 20, 2029 | Drug product | None | 216718 |
| 8124799 | December 3, 2029 | Drug substance | None | 216718 |
| 9701709 | April 24, 2033 | Drug substance, Drug product | None | 216718 |
| 8993640 | April 24, 2033 | Drug substance, Drug product | None | 216718 |
Skyclarys exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-270 | Miscellaneous | December 20, 2027 | 216718 |
| NCE | New chemical entity | February 28, 2028 | 216718 |
| ODE-427 | Orphan drug exclusivity | February 28, 2030 | 216718 |
Skyclarys NDC codes
Questions
Is there a generic for Skyclarys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Skyclarys (omaveloxolone). The Orange Book shows its last listed patent expires April 24, 2033 and its last listed exclusivity ends February 28, 2030.
What is the generic name for Skyclarys?
The active ingredient in Skyclarys is omaveloxolone, per the FDA Orange Book.
When does the Skyclarys patent expire?
The last patent listed for Skyclarys in the Orange Book expires April 24, 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.