TAVALISSE — FDA application NDA209299
Listed sponsor: RIGEL PHARMS · RIGL company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 8211889 | 001 | listed patent expiry date: 2026-01-19 | drug substance |
| Patent 8211889 | 002 | listed patent expiry date: 2026-01-19 | drug substance |
| Patent 9266912 | 001 | listed patent expiry date: 2026-01-19 | U-2294 |
| Patent 9266912 | 002 | listed patent expiry date: 2026-01-19 | U-2294 |
| Patent RE48898 | 001 | listed patent expiry date: 2026-01-19 | drug product |
| Patent RE48898 | 002 | listed patent expiry date: 2026-01-19 | drug product |
| Patent 7538108 | 001 | listed patent expiry date: 2026-03-28 | drug substance, U-2294 |
| Patent 7538108 | 002 | listed patent expiry date: 2026-03-28 | drug substance, U-2294 |
| Patent 7989448 | 001 | listed patent expiry date: 2026-06-12 | drug substance, U-2294 |
| Patent 7989448 | 002 | listed patent expiry date: 2026-06-12 | drug substance, U-2294 |
| Patent 8163902 | 001 | listed patent expiry date: 2026-06-17 | drug substance, U-2294 |
| Patent 8163902 | 002 | listed patent expiry date: 2026-06-17 | drug substance, U-2294 |
| Patent 8445485 | 001 | listed patent expiry date: 2026-06-17 | drug product |
| Patent 8445485 | 002 | listed patent expiry date: 2026-06-17 | drug product |
| Patent 8912170 | 001 | listed patent expiry date: 2026-06-17 | U-2294 |
| Patent 8912170 | 002 | listed patent expiry date: 2026-06-17 | U-2294 |
| Patent 9283238 | 001 | listed patent expiry date: 2026-06-17 | U-2294 |
| Patent 9283238 | 002 | listed patent expiry date: 2026-06-17 | U-2294 |
| Patent 8652492 | 001 | listed patent expiry date: 2028-11-06 | drug product |
| Patent 8652492 | 002 | listed patent expiry date: 2028-11-06 | drug product |
| Patent 8263122 | 001 | listed patent expiry date: 2030-11-24 | drug product |
| Patent 8263122 | 002 | listed patent expiry date: 2030-11-24 | drug product |
| Patent 7449458 | 001 | listed patent expiry date: 2031-09-04 | drug substance |
| Patent 7449458 | 002 | listed patent expiry date: 2031-09-04 | drug substance |
| Patent 8771648 | 001 | listed patent expiry date: 2032-07-27 | drug product |
| Patent 8771648 | 002 | listed patent expiry date: 2032-07-27 | drug product |
| Patent 8951504 | 001 | listed patent expiry date: 2032-07-27 | U-2294 |
| Patent 8951504 | 002 | listed patent expiry date: 2032-07-27 | U-2294 |
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 · CHEMBL2103830
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.