NDAINTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASEPriority Review
Approved
Apr 2006
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Clinical Trials (5)
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
Started Apr 2026
A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
Started Jul 2025
150 enrolled
Alcohol AddictionAlcoholism
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Started Jun 2025
Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)
Started Mar 2022
Naltrexone in AUD Reward Drinkers
Started Mar 2022
Loss of Exclusivity
LOE Date
Oct 15, 2029
44 months away
Patent Expiry
Oct 15, 2029
Patent Records (1)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 7919499 | Oct 15, 2029 | U-1123 |
Company
Alkermes
DUBLIN 4, Ireland