Wednesday, July 8, 2026

Drug profile · INN

buprenorphine hydrochloride

buprenorphine hydrochloride (BUPRENORPHINE HYDROCHLORIDE) is a mu opioid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: implantation. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 2
Pipeline programs 12
News articles 0
Drug details — buprenorphine hydrochloride
US status
approved
Class
Route
IMPLANTATION
Patents
2
Programs
12
Data quality
0.89

Quick answer

buprenorphine hydrochloride (BUPRENORPHINE HYDROCHLORIDE) is a mu opioid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: implantation. Current US regulatory status: approved.

Key facts

INN buprenorphine hydrochloride
Brand BUPRENORPHINE HYDROCHLORIDE
Mechanism Mu opioid receptor agonist
Target Kappa-type opioid receptor
Route IMPLANTATION
Formulation FILM

Mechanism of action

Mu opioid receptor agonist

Primary target: Kappa-type opioid receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Probuphine (buprenorphine implant) Phase 3 · BRIGHT MINDS BIOSCIENCES · Opioid Dependency
  2. SUBOXONE Phase 3 · Indivior Pty · Opioid Dependence
  3. SUBOXONE sublingual film Phase 3 · Indivior Pty · Opioid Use Disorder
  4. 2mg Buprenex and 380mg Vivitrol Phase 2 · United Therapeutics Europe · Post Traumatic Stress Disorder
  5. Buprenorphine hydrochloride marketed sublingual tablet (Subutex) Phase 2 · Indivior Pty · Opioid Dependency
  6. Suboxone Remote Observed Dosing Phase 2 · BRIGHT MINDS BIOSCIENCES · Opioid-use Disorder
  7. Suboxone Phase 1 · BRIGHT MINDS BIOSCIENCES · Cocaine-related Disorders
  8. Buprenorphine (Subutex) Approved · Indivior Pty · Opioid Dependency

Related & competitor drugs

  1. buprenorphine Nervous system (N07)
  2. anileridine hydrochloride Kappa opioid receptor agonist
  3. anileridine phosphate Kappa opioid receptor agonist
  4. butorphanol tartrate Kappa opioid receptor partial agonist
  5. dezocine Kappa opioid receptor antagonist
  6. difelikefalin acetate Kappa opioid receptor agonist
  1. US 11135216

    Sublingual and buccal film compositions

    Expires Mon Sep 30 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9687454

    Sublingual and buccal film compositions

    Expires Mon Jun 22 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is buprenorphine hydrochloride?

buprenorphine hydrochloride (BUPRENORPHINE HYDROCHLORIDE) is a mu opioid receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: implantation. Current US regulatory status: approved.

What is the brand name for buprenorphine hydrochloride?

BUPRENORPHINE HYDROCHLORIDE is a marketed brand name for buprenorphine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of buprenorphine hydrochloride?

buprenorphine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.