FDA Orange Book
Is there a generic for Rytelo?
Rytelo contains imetelstat. 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 Rytelo (imetelstat). The Orange Book shows its last listed patent expires June 16, 2039 and its last listed exclusivity ends June 6, 2031.
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Rytelo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 188MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, intravenous | EQ 47MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 217779, held by GERON CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rytelo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9388416 | September 9, 2026 | Method of use | U-3956 | 217779 |
| 9388415 | September 9, 2026 | Method of use | U-3956 | 217779 |
| 7494982 | December 27, 2026 | Drug substance, Drug product | None | 217779 |
| 12442000 | March 15, 2033 | Method of use | U-3956 | 217779 |
| 9375485 | March 15, 2033 | Method of use | U-3956 | 217779 |
| 12171778 | June 16, 2039 | Method of use | U-3956 | 217779 |
Rytelo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-482 | Orphan drug exclusivity | June 6, 2031 | 217779 |
Rytelo NDC codes
Questions
Is there a generic for Rytelo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rytelo (imetelstat). The Orange Book shows its last listed patent expires June 16, 2039 and its last listed exclusivity ends June 6, 2031.
What is the generic name for Rytelo?
The active ingredient in Rytelo is imetelstat, per the FDA Orange Book.
When does the Rytelo patent expire?
The last patent listed for Rytelo in the Orange Book expires June 16, 2039. 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.