FDA Orange Book · active-ingredient family
Fostamatinib disodium
Fostamatinib disodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TAVALISSE · NDA 209299
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAVALISSERLD×2 | RIGEL PHARMS | NDA 209299 | — | Apr 17, 2018 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9266912 | Jan 19, 2026 | 5 mo ago | U-2294 |
| 8211889 | Jan 19, 2026 | 5 mo ago | Substance |
| RE48898 | Jan 19, 2026 | 5 mo ago | Product |
| 7538108 | Mar 28, 2026 | 3 mo ago | SubstanceU-2294 |
| 7989448 | Jun 12, 2026 | 7 d ago | SubstanceU-2294 |
| 9283238 | Jun 17, 2026 | 2 d ago | U-2294 |
| 8912170 | Jun 17, 2026 | 2 d ago | U-2294 |
| 8163902 | Jun 17, 2026 | 2 d ago | SubstanceU-2294 |
| 8445485 | Jun 17, 2026 | 2 d ago | Product |
| 8652492 | Nov 06, 2028 | in 2 yr 5 mo | Product |
| 8263122 | Nov 24, 2030 | in 4 yr 6 mo | Product |
| 7449458 | Sep 04, 2031 | in 5 yr 3 mo | Substance |
| 8951504 | Jul 27, 2032 | in 6 yr 2 mo | U-2294 |
| 8771648 | Jul 27, 2032 | in 6 yr 2 mo | Product |
Fostamatinib disodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
