FDA Orange Book · active-ingredient family
Dexlansoprazole
Dexlansoprazole: 2 brands, 4 generics; first approved Jan 30, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
14
Next patent expiry
Jan 17, 2026
7 mo ago
Brand (NDA) products
Originator applications
- TAKEDA PHARMS USANDA 2080562016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Discontinued — - DEXILANTRLDTAKEDA PHARMS USANDA 02228720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, DELAYED RELEASE ORAL Rx AB 60MG CAPSULE, DELAYED RELEASE ORAL Rx AB
Generic (ANDA) products (4)
Abbreviated applications
- DEXLANSOPRAZOLEALEMBICANDA 21911520252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, DELAYED RELEASE ORAL Rx AB 60MG CAPSULE, DELAYED RELEASE ORAL Rx AB - DEXLANSOPRAZOLEMYLANANDA 20520520242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, DELAYED RELEASE ORAL Rx AB 60MG CAPSULE, DELAYED RELEASE ORAL Rx AB - DEXLANSOPRAZOLETWI PHARMSANDA 20266620222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, DELAYED RELEASE ORAL Rx AB 60MG CAPSULE, DELAYED RELEASE ORAL Rx AB - DEXLANSOPRAZOLEPH HEALTHANDA 20229420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, DELAYED RELEASE ORAL Rx AB 30MG CAPSULE, DELAYED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9238029 | 7 mo ago | Product | |
| 8461187 | 7 mo ago | Product | |
| 9011926 | 6 mo ago | Product | |
| 8461187*PED | 26 d ago | ||
| 7790755 | 10 d ago | Product | |
| 8105626 | in 2 mo | Product | |
| 7790755*PED | in 6 mo | ||
| 8105626*PED | in 8 mo | ||
| 8871273 | in 1 yr 5 mo | Product | |
| 8871273*PED | in 1 yr 11 mo | ||
| 9241910 | in 2 yr 7 mo | Product | |
| 8173158 | in 3 yr 8 mo | U-951 | |
| 8173158*PED | in 4 yr 2 mo | ||
| 9233103 | in 5 yr 8 mo | U-1805 |
Approval history
FDA approval span
First approval
17 yr 9 mo ago
Most recent approval
9 mo ago
Approvals span 2009–2025 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Dexlansoprazole: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
