fostamatinib disodium · Rigel Pharms · NDA 209299
Tavalisse
Earliest generic entry, as listed · earliest of 2 marketed strengths
27 Jul 2032
Blocked by patent: US 8771648, US 8951504.
FDA has approved 1 generic application (ANDA) for Tavalisse, though its earliest generic-entry date is 27 Jul 2032 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8771648 | drug product · sets the listed date | 27 Jul 2032 |
| US 8951504 | use U-2294 · sets the listed date | 27 Jul 2032 |
| US 7449458 | drug substance | 4 Sep 2031 |
| US 8263122 | drug product | 24 Nov 2030 |
| US 8652492 | drug product | 6 Nov 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- First generic approved · ANDA 217329, Annora Pharma · 209299-001Approved 17 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217329, Annora Pharma · 209299-001Approved 17 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209299 · 001 · RLD | tablet, oral | EQ 100MG BASE | 27 Jul 2032 |
| 209299 · 002 · RLD | tablet, oral | EQ 150MG BASE | 27 Jul 2032 |
Expired or delisted (9)
- US 8163902 · substance, use U-2294 · 17 Jun 2026
- US 8445485 · product · 17 Jun 2026
- US 8912170 · use U-2294 · 17 Jun 2026
- US 9283238 · use U-2294 · 17 Jun 2026
- US 7989448 · substance, use U-2294 · 12 Jun 2026
- US 7538108 · substance, use U-2294 · 28 Mar 2026
- US 8211889 · substance · 19 Jan 2026
- US 9266912 · use U-2294 · 19 Jan 2026
- US RE48898 · product · 19 Jan 2026