Assyro AI

Orange Book product · Brand (NDA)

TAVALISSE

FOSTAMATINIB DISODIUM

Brand (NDA)NDA 209299RX RIGEL PHARMS

At a glance

Apr 17, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

14

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 17, 2018

    8 yr 4 mo ago

  2. Patent 8211889 expires

    Listed drug substance patent expiration.

    Jan 19, 2026

    5 mo ago

  3. Patent 9266912 expires

    Listed method-of-use patent (U-2294) expiration.

    Jan 19, 2026

    5 mo ago

  4. Patent RE48898 expires

    Listed drug product patent expiration.

    Jan 19, 2026

    5 mo ago

  5. Patent 7538108 expires

    Listed drug substance patent expiration.

    Mar 28, 2026

    3 mo ago

  6. Patent 7989448 expires

    Listed drug substance patent expiration.

    Jun 12, 2026

    7 d ago

  7. Patent 8163902 expires

    Listed drug substance patent expiration.

    Jun 17, 2026

    2 d ago

  8. Patent 8445485 expires

    Listed drug product patent expiration.

    Jun 17, 2026

    2 d ago

  9. Patent 8912170 expires

    Listed method-of-use patent (U-2294) expiration.

    Jun 17, 2026

    2 d ago

  10. Patent 9283238 expires

    Listed method-of-use patent (U-2294) expiration.

    Jun 17, 2026

    2 d ago

  11. Today

  12. Patent 8652492 expires

    Listed drug product patent expiration.

    Nov 06, 2028

    in 2 yr 5 mo

  13. Patent 8263122 expires

    Listed drug product patent expiration.

    Nov 24, 2030

    in 4 yr 6 mo

  14. Patent 7449458 expires

    Listed drug substance patent expiration.

    Sep 04, 2031

    in 5 yr 3 mo

  15. Patent 8771648 expires

    Listed drug product patent expiration.

    Jul 27, 2032

    in 6 yr 2 mo

  16. 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 family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8211889Jan 19, 20265 mo ago
Substance
9266912Jan 19, 20265 mo ago
U-2294
RE48898Jan 19, 20265 mo ago
Product
7538108Mar 28, 20263 mo ago
SubstanceU-2294
7989448Jun 12, 20267 d ago
SubstanceU-2294
8163902Jun 17, 20262 d ago
SubstanceU-2294
8445485Jun 17, 20262 d ago
Product
8912170Jun 17, 20262 d ago
U-2294
9283238Jun 17, 20262 d ago
U-2294
8652492Nov 06, 2028in 2 yr 5 mo
Product
8263122Nov 24, 2030in 4 yr 6 mo
Product
7449458Sep 04, 2031in 5 yr 3 mo
Substance
8771648Jul 27, 2032in 6 yr 2 mo
Product
8951504Jul 27, 2032in 6 yr 2 mo
U-2294
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.