# TAVALISSE — FDA application NDA209299

Informational only - not investment advice.

Application NDA209299 · type NDA · FDA status: approved · original approval 2018-04-17

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 | TAVALISSE | FOSTAMATINIB DISODIUM | TABLET | ORAL | EQ 100MG BASE | Prescription | AB | Yes |
| 002 | TAVALISSE | FOSTAMATINIB DISODIUM | TABLET | ORAL | EQ 150MG BASE | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent 8211889, product 001; listed patent expiry date: 2026-01-19.
- Patent 8211889, product 002; listed patent expiry date: 2026-01-19.
- Patent 9266912, product 001; listed patent expiry date: 2026-01-19.
- Patent 9266912, product 002; listed patent expiry date: 2026-01-19.
- Patent RE48898, product 001; listed patent expiry date: 2026-01-19.
- Patent RE48898, product 002; listed patent expiry date: 2026-01-19.
- Patent 7538108, product 001; listed patent expiry date: 2026-03-28.
- Patent 7538108, product 002; listed patent expiry date: 2026-03-28.
- Patent 7989448, product 001; listed patent expiry date: 2026-06-12.
- Patent 7989448, product 002; listed patent expiry date: 2026-06-12.
- Patent 8163902, product 001; listed patent expiry date: 2026-06-17.
- Patent 8163902, product 002; listed patent expiry date: 2026-06-17.
- Patent 8445485, product 001; listed patent expiry date: 2026-06-17.
- Patent 8445485, product 002; listed patent expiry date: 2026-06-17.
- Patent 8912170, product 001; listed patent expiry date: 2026-06-17.
- Patent 8912170, product 002; listed patent expiry date: 2026-06-17.
- Patent 9283238, product 001; listed patent expiry date: 2026-06-17.
- Patent 9283238, product 002; listed patent expiry date: 2026-06-17.
- Patent 8652492, product 001; listed patent expiry date: 2028-11-06.
- Patent 8652492, product 002; listed patent expiry date: 2028-11-06.
- Patent 8263122, product 001; listed patent expiry date: 2030-11-24.
- Patent 8263122, product 002; listed patent expiry date: 2030-11-24.
- Patent 7449458, product 001; listed patent expiry date: 2031-09-04.
- Patent 7449458, product 002; listed patent expiry date: 2031-09-04.
- Patent 8771648, product 001; listed patent expiry date: 2032-07-27.
- Patent 8771648, product 002; listed patent expiry date: 2032-07-27.
- Patent 8951504, product 001; listed patent expiry date: 2032-07-27.
- Patent 8951504, product 002; listed patent expiry date: 2032-07-27.

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

- FOSTAMATINIB · UNII SQ8A3S5101 · [lmmol compound GKDRMWXFWHEQQT-UHFFFAOYSA-N](https://lmmol.com/compound/GKDRMWXFWHEQQT-UHFFFAOYSA-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:NDA209299. FDA data retrieved 2026-08-07.

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