NDAIMPLANTATIONIMPLANTPriority Review
Approved
May 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
PROBUPHINE (buprenorphine hydrochloride) by Teva is naloxone. First approved in 2016.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROBUPHINE is a subdermal implant delivering buprenorphine hydrochloride for the treatment of opioid use disorder. Buprenorphine is a partial mu-opioid agonist and kappa-opioid antagonist that reduces cravings and withdrawal symptoms. The implant provides sustained-release medication over an extended period, offering an alternative to daily oral or sublingual formulations.
Peak
Product is at peak lifecycle stage with moderate competitive pressure (30), suggesting stable team size and focus on market maintenance and physician engagement.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Probuphine Innovations for Clinical Effectiveness (PRINCE)
Started Sep 2016
15 enrolled
Opioid Dependence
Career Relevance
PROBUPHINE represents a specialized career opportunity in opioid use disorder treatment, requiring deep knowledge of addiction medicine, payer dynamics, and implantable device logistics. Working on this product provides exposure to REMS-adjacent compliance frameworks, addiction medicine networks, and integrated patient support programs.
Brand Manager
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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.