Orange Book product · Brand (NDA)
TAVALISSE
FOSTAMATINIB DISODIUM
At a glance
Apr 17, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 17, 2018
8 yr 4 mo ago
Patent 8211889 expires
Listed drug substance patent expiration.
Jan 19, 2026
5 mo ago
Patent 9266912 expires
Listed method-of-use patent (U-2294) expiration.
Jan 19, 2026
5 mo ago
Patent RE48898 expires
Listed drug product patent expiration.
Jan 19, 2026
5 mo ago
Patent 7538108 expires
Listed drug substance patent expiration.
Mar 28, 2026
3 mo ago
Patent 7989448 expires
Listed drug substance patent expiration.
Jun 12, 2026
7 d ago
Patent 8163902 expires
Listed drug substance patent expiration.
Jun 17, 2026
2 d ago
Patent 8445485 expires
Listed drug product patent expiration.
Jun 17, 2026
2 d ago
Patent 8912170 expires
Listed method-of-use patent (U-2294) expiration.
Jun 17, 2026
2 d ago
Patent 9283238 expires
Listed method-of-use patent (U-2294) expiration.
Jun 17, 2026
2 d ago
Today
Patent 8652492 expires
Listed drug product patent expiration.
Nov 06, 2028
in 2 yr 5 mo
Patent 8263122 expires
Listed drug product patent expiration.
Nov 24, 2030
in 4 yr 6 mo
Patent 7449458 expires
Listed drug substance patent expiration.
Sep 04, 2031
in 5 yr 3 mo
Patent 8771648 expires
Listed drug product patent expiration.
Jul 27, 2032
in 6 yr 2 mo
Patent 8951504 expires
Listed method-of-use patent (U-2294) expiration.
Jul 27, 2032
in 6 yr 2 mo
Pharmaceutical detail
Active ingredient
FOSTAMATINIB DISODIUM
Strength
EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209299
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8211889 | Jan 19, 2026 | 5 mo ago | Substance |
| 9266912 | Jan 19, 2026 | 5 mo ago | U-2294 |
| 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 |
| 8163902 | Jun 17, 2026 | 2 d ago | SubstanceU-2294 |
| 8445485 | Jun 17, 2026 | 2 d ago | Product |
| 8912170 | Jun 17, 2026 | 2 d ago | U-2294 |
| 9283238 | Jun 17, 2026 | 2 d ago | U-2294 |
| 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 |
| 8771648 | Jul 27, 2032 | in 6 yr 2 mo | Product |
| 8951504 | Jul 27, 2032 | in 6 yr 2 mo | U-2294 |

