Last reviewed · How we verify
Subutex (BUPRENORPHINE)
Buprenorphine binds to mu-opioid receptors as a partial agonist and kappa-opioid receptors as an antagonist.
Buprenorphine (Subutex), marketed by Purdue Pharma LP, is a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist primarily indicated for opioid dependence treatment. A key strength of Subutex is its unique mechanism as a partial agonist, which provides a ceiling effect on respiratory depression, reducing the risk of overdose compared to full opioid agonists. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | BUPRENORPHINE |
|---|---|
| Sponsor | Purdue Pharma Lp |
| Drug class | Partial Opioid Agonist |
| Target | mu-opioid receptor, kappa-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1981 |
| Annual revenue | 800 |
Mechanism of action
Buprenorphine works by partially activating the mu-opioid receptors, which helps reduce pain and cravings, while also blocking the kappa-opioid receptors, which can help prevent certain side effects.
Approved indications
- Opioid Dependence Treatment
Common side effects
- Headache
- Pain
- Pain Abdomen
- Pain Back
- Withdrawal Syndrome
- Constipation
- Nausea
- Vomiting
- Insomnia
- Rhinitis
- Sweating
Drug interactions
- alfentanil
- amiodarone
- bretylium
- butorphanol
- chlordiazepoxide
- clonazepam
- codeine
- diazepam
- disopyramide
- dofetilide
- erythromycin
- estazolam
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System (NA)
- Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (PHASE2)
- Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
- Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People (EARLY_PHASE1)
- Extended-release Buprenorphine as a Novel Low-dose Induction Strategy (PHASE2)
- Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial (NA)
- Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9827241 | 2031-06-06 | Formulation |
| 9782402 | 2031-06-06 | Formulation |
| 9272044 | 2031-06-06 | Method of Use |
| 8975270 | 2031-09-05 | Formulation |
| 8921387 | 2032-01-06 | Formulation |
| 9498432 | 2031-06-06 | Formulation |
| 10198218 | 2031-06-06 | Method of Use |
| 12318379 | 2032-07-26 | Formulation |
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Subutex CI brief — competitive landscape report
- Subutex updates RSS · CI watch RSS
- Purdue Pharma Lp portfolio CI