NDABUCCALFILM
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
BELBUCA (buprenorphine hydrochloride) by Teva is mu-opioid receptor and an antagonist at the kappa-opioid receptor. First approved in 2015.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BELBUCA is a buccal film formulation of buprenorphine hydrochloride, a mu-opioid receptor agonist and kappa-opioid receptor antagonist indicated for chronic pain management. The buccal route enables rapid absorption and offers an alternative delivery mechanism to traditional oral or transdermal opioid formulations. It is designed for opioid-tolerant patients requiring around-the-clock pain relief.
$150MPart D
PeakStable
6.5 years to LOEProduct is at peak maturity with substantial Part D spending (~$150M in 2023); marketing teams are likely focused on market defense and patient retention rather than aggressive expansion.
Mechanism of Action
mu-opioid receptor and an antagonist at the kappa-opioid receptor.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
$150M Medicare spend — this is a commercially significant brand
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.