NDAIMPLANTATIONIMPLANTPriority Review
Approved
May 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
PROBUPHINE (buprenorphine hydrochloride) by Teva is naloxone. Approved for opioid dependence, drug dependence. First approved in 2016.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROBUPHINE is a subdermal implant containing buprenorphine hydrochloride, a partial mu-opioid receptor agonist, approved for maintenance treatment of opioid dependence. The implant delivers consistent buprenorphine levels over 6 months, eliminating daily dosing variability. It represents a novel long-acting modality designed to improve treatment adherence in opioid use disorder.
Peak
Product in peak commercial phase with moderate competitive pressure; team likely focused on maximizing market penetration and defending against generic/biosimilar threats.
Mechanism of Action
naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is an opioid antagonist and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
Indications (2)
Clinical Trials (1)
Probuphine Innovations for Clinical Effectiveness (PRINCE)
Started Sep 2016
15 enrolled
Opioid Dependence
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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.