BELBUCA (buprenorphine hydrochloride)
BELBUCA is a buccal film indicated for the management of severe and persistent pain that requires daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Because of the risks of addiction, abuse, and misuse, it is reserved for patients for whom alternative treatments (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate. BELBUCA is not indicated for use as an as-needed (PRN) analgesic.
How BELBUCA Works
Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. As a partial mu-agonist, it binds with high affinity, which can result in the displacement of other opioids and exhibits a ceiling effect on respiratory depression compared to full opioid agonists.
Details
- Status
- Prescription
- First Approved
- 2015-10-23
- Patent Cliff
- 2032
- Routes
- BUCCAL
- Dosage Forms
- FILM
BELBUCA Approval History
What BELBUCA Treats
1 indicationsBELBUCA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
BELBUCA Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BELBUCA WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF BELBUCA See full prescribing information for complete boxed warning. BELBUCA exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a ...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BELBUCA WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF BELBUCA See full prescribing information for complete boxed warning. BELBUCA exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of BELBUCA are essential. Instruct patients on proper administration of BELBUCA to reduce the risk. ( 2.1 , 2.8 , 5.2 ) Accidental exposure to BELBUCA, especially in children, can result in fatal overdose of buprenorphine. ( 5.2 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.4 ) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. ( 5.5 ) Addiction, Abuse, and Misuse Because the use of BELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.
BELBUCA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BELBUCA FDA Label Details
Indications & Usage
FDA Label (PDF)BELBUCA is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BELBUCA WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF BELBUCA See full prescribing information for complete boxed warning. BELBUCA exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patien...
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 147 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.