NDATRANSDERMALFILM, EXTENDED RELEASE
Approved
Jun 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
BUTRANS (buprenorphine) by Purdue Pharma is partial opioid agonists [moa]. First approved in 2010.
Drug data last refreshed 13h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BUTRANS is a transdermal extended-release film formulation of buprenorphine, a partial opioid agonist approved in 2010 for chronic pain management. It delivers consistent opioid analgesia through the skin over extended periods, reducing breakthrough pain and the need for frequent dosing. The partial agonist mechanism provides a ceiling effect on respiratory depression compared to full opioids, making it a safer opioid option for chronic pain patients.
$23MPart D
LOE ApproachingProduct is approaching loss of exclusivity with moderate Medicare Part D spending; expect transition from growth-focused to defensive and efficiency-driven commercial activities.
Mechanism of Action
Partial Opioid Agonists
Pharmacologic Class:
Partial Opioid Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
Started Aug 2026
60 enrolled
Opioid Use Disorder
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Started Dec 2025
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
Started Jan 2025
12 enrolled
Opioid Use Disorder
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Started Jan 2025
32 enrolled
Healthy Volunteer Study
An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
Started Jan 2025
60 enrolled
Autism Spectrum Disorder
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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.