dexlansoprazole · Takeda Pharms Usa · NDA 022287
Dexilant
Blocked by patent: US 9233103. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 1 generic application (ANDA) for Dexilant, though its earliest generic-entry date is 5 Mar 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
8 Orange Book listing rows for 5 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9233103 | use U-1805 · sets the listed date | 5 Mar 2032 |
| US 8173158 | use U-949, U-950, U-951 | 17 Sep 2030 |
| US 8173158 listing row | use U-949 | 17 Mar 2030 |
| US 8173158 listing row | use U-950 | 17 Mar 2030 |
| US 8173158 listing row | use U-951 | 17 Mar 2030 |
| US 8173158 listing row | pediatric extension | 17 Sep 2030 |
| US 8871273 | drug product | 11 Jan 2028 |
| US 8105626 | pediatric extension | 27 Mar 2027 |
| US 7790755 | pediatric extension | 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