FDA Orange Book
Generic for Tavalisse
Tavalisse contains fostamatinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tavalisse is fostamatinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tavalisse products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 209299, held by RIGEL PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fostamatinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANNORA PHARMA PRIVATE LTD | 217329 | AB (A-rated, therapeutically equivalent) | June 17, 2026 | EQ 100MG BASE, EQ 150MG BASE |
Tavalisse patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9266912 | January 19, 2026 | Method of use | U-2294 | 209299 |
| 8211889 | January 19, 2026 | Drug substance | None | 209299 |
| RE48898 | January 19, 2026 | Drug product | None | 209299 |
| 7538108 | March 28, 2026 | Drug substance | U-2294 | 209299 |
| 7989448 | June 12, 2026 | Drug substance | U-2294 | 209299 |
| 9283238 | June 17, 2026 | Method of use | U-2294 | 209299 |
| 8912170 | June 17, 2026 | Method of use | U-2294 | 209299 |
| 8163902 | June 17, 2026 | Drug substance | U-2294 | 209299 |
| 8445485 | June 17, 2026 | Drug product | None | 209299 |
| 8652492 | November 6, 2028 | Drug product | None | 209299 |
| 8263122 | November 24, 2030 | Drug product | None | 209299 |
| 7449458 | September 4, 2031 | Drug substance | None | 209299 |
| 8951504 | July 27, 2032 | Method of use | U-2294 | 209299 |
| 8771648 | July 27, 2032 | Drug product | None | 209299 |
Tavalisse NDC codes
Questions
Is there a generic for Tavalisse?
Yes. The generic name for Tavalisse is fostamatinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Tavalisse?
The active ingredient in Tavalisse is fostamatinib, per the FDA Orange Book.
When does the Tavalisse patent expire?
The last patent listed for Tavalisse in the Orange Book expires July 27, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.