# REZLIDHIA — FDA application NDA215814

Informational only - not investment advice.

Application NDA215814 · type NDA · FDA status: approved · original approval 2022-12-01

Listed sponsor: RIGEL PHARMS · [RIGL company profile](/company/RIGL/) · 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 | REZLIDHIA | OLUTASIDENIB | CAPSULE | ORAL | 150MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10414752, product 001; listed patent expiry date: 2035-09-18.
- Patent 10550098, product 001; listed patent expiry date: 2035-09-18.
- Patent 11498913, product 001; listed patent expiry date: 2035-09-18.
- Patent 12275715, product 001; listed patent expiry date: 2035-09-18.
- Patent 9834539, product 001; listed patent expiry date: 2035-09-18.
- Patent 10532047, product 001; listed patent expiry date: 2039-05-16.
- Patent 10959994, product 001; listed patent expiry date: 2039-05-16.
- Patent 11013733, product 001; listed patent expiry date: 2039-05-16.
- Patent 11013734, product 001; listed patent expiry date: 2039-05-16.
- Patent 11376246, product 001; listed patent expiry date: 2039-05-16.
- Patent 11497743, product 001; listed patent expiry date: 2039-05-16.
- Patent 12053463, product 001; listed patent expiry date: 2039-05-16.
- Patent 11738018, product 001; listed patent expiry date: 2039-07-17.
- Patent 11723905, product 001; listed patent expiry date: 2039-11-12.
- Exclusivity NCE, product 001; listed exclusivity date: 2027-12-01.
- Exclusivity ODE-413, product 001; listed exclusivity date: 2029-12-01.

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

- OLUTASIDENIB · UNII 0T4IMT8S5Z · [lmmol compound NEQYWYXGTJDAKR-JTQLQIEISA-N](https://lmmol.com/compound/NEQYWYXGTJDAKR-JTQLQIEISA-N)

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/RIGL/)
- [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:NDA215814. FDA data retrieved 2026-08-07.

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