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Buprenorphine Transdermal System
Buprenorphine Transdermal System is a Small molecule drug developed by Mundipharma K.K.. It is currently FDA-approved. Also known as: Butrans™, Butrans.
Buprenorphine Transdermal System, marketed by Mundipharma K.K., is a pain management solution with a key composition patent expiring in 2028. The drug's primary strength lies in its established market presence and mechanism of action, which differentiates it from other pain management options. The primary risk is the potential increase in competition post-patent expiry in 2028.
At a glance
| Generic name | Buprenorphine Transdermal System |
|---|---|
| Also known as | Butrans™, Butrans |
| Sponsor | Mundipharma K.K. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE) (PHASE3)
- Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery (PHASE4)
- An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders (NA)
- Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy (PHASE4)
- Improved Pain Management in Knee Osteoarthritis-related Surgeries
- Butrans for Treatment of Restless Legs Syndrome (PHASE4)
- Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy (EARLY_PHASE1)
- Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Buprenorphine Transdermal System CI brief — competitive landscape report
- Buprenorphine Transdermal System updates RSS · CI watch RSS
- Mundipharma K.K. portfolio CI
Frequently asked questions about Buprenorphine Transdermal System
What is Buprenorphine Transdermal System?
Who makes Buprenorphine Transdermal System?
Is Buprenorphine Transdermal System also known as anything else?
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Related
- Manufacturer: Mundipharma K.K. — full pipeline
- Also known as: Butrans™, Butrans
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing