FDA Orange Book · active-ingredient family
Dexlansoprazole
Dexlansoprazole is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEXILANT SOLUTAB · NDA 208056
2
Brand (NDA)
4
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed release, tablet, orally disintegrating, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXILANT SOLUTABRLD | TAKEDA PHARMS USA | NDA 208056 | — | Jan 26, 2016 | |
| DEXILANTRLD×2 | TAKEDA PHARMS USA | NDA 022287 | AB | Jan 30, 2009 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXLANSOPRAZOLE×2 | ALEMBIC | ANDA 219115 | AB | Nov 12, 2025 | |
| DEXLANSOPRAZOLE×2 | MYLAN | ANDA 205205 | AB | Jan 19, 2024 | |
| DEXLANSOPRAZOLE×2 | TWI PHARMS | ANDA 202666 | AB | Sep 16, 2022 | |
| DEXLANSOPRAZOLE×2 | PH HEALTH | ANDA 202294 | AB | Jun 16, 2022 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9238029 | Jan 17, 2026 | 5 mo ago | Product |
| 8461187 | Jan 17, 2026 | 5 mo ago | Product |
| 9011926 | Feb 24, 2026 | 4 mo ago | Product |
| 8461187*PED | Jul 17, 2026 | in 28 d | |
| 7790755 | Aug 02, 2026 | in 1 mo | Product |
| 8105626 | Sep 27, 2026 | in 3 mo | Product |
| 7790755*PED | Feb 02, 2027 | in 8 mo | |
| 8105626*PED | Mar 27, 2027 | in 9 mo | |
| 8871273 | Jan 11, 2028 | in 1 yr 7 mo | Product |
| 8871273*PED | Jul 11, 2028 | in 2 yr 1 mo | |
| 9241910 | Mar 10, 2029 | in 2 yr 9 mo | Product |
| 8173158 | Mar 17, 2030 | in 3 yr 10 mo | U-951 |
| 8173158*PED | Sep 17, 2030 | in 4 yr 4 mo | |
| 9233103 | Mar 05, 2032 | in 5 yr 10 mo | U-1805 |
Dexlansoprazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
