EMA · European Union
buprenorphine — EMA regulatory status
buprenorphine (B-PATCH) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- B-PATCH
- Originator
- Indivior Pty Ltd
- Mechanism
- Kappa opioid receptor agonist
- Target
- Kappa-type opioid receptor
- Structured fields
- 8
Sponsor / originator context: Indivior Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Kappa opioid receptor agonist. Target: Kappa-type opioid receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 61 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Buprenorphine | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00000211, NCT00000214 |
| Buprenorphine | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT04991974 |
| Buprenorphine | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00000302, NCT00023283 |
| Buprenorphine + Naltrexone | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01402492 |
| Buprenorphine +OTP | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00574067 |
| Buprenorphine Injection | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT03918850 |
| Buprenorphine Transdermal System | Phase 3 | Chinese Academy of | NCT01476774 |
| Buprenorphine/Naloxone | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00270257 |
| Buprenorphine/naloxone | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00015288, NCT00032955 |
| Buprenorphine/naloxone | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00000344, NCT00015028 |
| Extended Release Buprenorphine | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT04345718 |
| Probuphine (buprenorphine implant) | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01114308 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12226429 | Highly active compounds against COVID-19 | US |
| 11839611 | Buprenorphine dosing regimens | US |
| 11813278 | Highly active compounds against COVID-19 | US |
| 11738038 | Highly active compounds against COVID-19 | US |
| 11707480 | Highly active compounds against COVID-19 | US |
| 11000520 | Buprenorphine dosing regimens | US |
| 10888529 | Vehicles for the transfection of miRNAs | US |
| 10874687 | Highly active compounds against COVID-19 | US |
| 10646484 | Methods to treat opioid use disorder | US |
| 10610597 | Polycarbonates bearing aromatic N-heterocycles for drug delivery | US |
| 10592168 | Injectable flowable composition comprising buprenorphine | US |
| 10584135 | Substituted 3,6-diazabicyclo[3.2.0]heptanes | US |
Related hubs
FAQ
What is the EMA approval status of buprenorphine?
buprenorphine currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get buprenorphine regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to buprenorphine?
This spoke lists 61 published programs associated with buprenorphine in our pipeline index.