# RYTELO — FDA application NDA217779

Informational only - not investment advice.

Application NDA217779 · type NDA · FDA status: approved · original approval 2024-06-06

Listed sponsor: GERON · [GERN company profile](/company/GERN/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | RYTELO | IMETELSTAT SODIUM | POWDER | INTRAVENOUS | EQ 47MG BASE/VIAL | Prescription | not listed | Yes |
| 002 | RYTELO | IMETELSTAT SODIUM | POWDER | INTRAVENOUS | EQ 188MG BASE/VIAL | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 9388415, product 001; listed patent expiry date: 2026-09-09.
- Patent 9388415, product 002; listed patent expiry date: 2026-09-09.
- Patent 9388416, product 001; listed patent expiry date: 2026-09-09.
- Patent 9388416, product 002; listed patent expiry date: 2026-09-09.
- Patent 7494982, product 001; listed patent expiry date: 2026-12-27.
- Patent 7494982, product 002; listed patent expiry date: 2026-12-27.
- Patent 12442000, product 001; listed patent expiry date: 2033-03-15.
- Patent 12442000, product 002; listed patent expiry date: 2033-03-15.
- Patent 9375485, product 001; listed patent expiry date: 2033-03-15.
- Patent 9375485, product 002; listed patent expiry date: 2033-03-15.
- Patent 12171778, product 001; listed patent expiry date: 2039-06-16.
- Patent 12171778, product 002; listed patent expiry date: 2039-06-16.
- Exclusivity ODE-482, product 001; listed exclusivity date: 2031-06-06.
- Exclusivity ODE-482, product 002; listed exclusivity date: 2031-06-06.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- IMETELSTAT SODIUM · UNII 2AW48LAZ4I · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/GERN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA217779. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.