dexlansoprazole · Takeda Pharms Usa · NDA 022287
Dexilant
Earliest generic entry, as listed · earliest of 2 marketed strengths
5 Mar 2032
Blocked by patent: US 9233103. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9233103 | use U-1805 | 5 Mar 2032 |
| US 8173158 | — | 17 Sep 2030 |
| US 8173158 | use U-950 | 17 Mar 2030 |
| US 8173158 | use U-951 | 17 Mar 2030 |
| US 8173158 | use U-949 | 17 Mar 2030 |
| US 8871273 | product | 11 Jan 2028 |
| US 8105626 | — | 27 Mar 2027 |
| US 7790755 | — | 2 Feb 2027 |
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
- 25 Oct 2026Generic approved · 022287-00112 Nov 2025
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022287 · 001 · RLD | capsule, delayed release, oral | 30MG | 5 Mar 2032 |
| 022287 · 002 · RLD | capsule, delayed release, oral | 60MG | 5 Mar 2032 |
Expired or delisted (6)
- US 8105626 · product · 27 Sep 2026
- US 7790755 · product · 2 Aug 2026
- US 8461187 · — · 17 Jul 2026
- US 9011926 · product · 24 Feb 2026
- US 8461187 · product · 17 Jan 2026
- US 9238029 · product · 17 Jan 2026