NDAORALCAPSULE, DELAYED RELEASE
Approved
Jan 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
48
Mechanism of Action
Proton Pump Inhibitors
Pharmacologic Class:
Proton Pump Inhibitor
Indications (6)
older for: Healing of all grades of erosive esophagitis (EE)older for healing of all grades of erosive esophagitis (EE) for up to eight weeksolder to maintain healing of EErelief of heartburn for up to six months in adults16 weeks in patients 12 to 17 years of ageolder for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks
Clinical Trials (5)
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
Started Jun 2025
0Pediatric Gastroesophageal Reflux Disease
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
Started May 2023
76 enrolled
Erosive Esophagitis
A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old
Started Feb 2023
70 enrolled
Gastroesophageal Reflux Disease (GERD)
A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants in the Russian Federation
Started Mar 2020
0Gastroesophageal Reflux Disease
A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules
Started Jan 2019
122 enrolled
Healthy Volunteers
Loss of Exclusivity
LOE Date
Mar 5, 2032
73 months away
Patent Expiry
Mar 5, 2032
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9238029 | Jan 17, 2026Expired | Product | — |
| 8461187 | Jan 17, 2026Expired | Product | — |
| 9011926 | Feb 24, 2026Expired | Product | — |
| 8461187*PED | Jul 17, 2026 | — | |
| 7790755 | Aug 2, 2026 | Product | — |