Wednesday, July 8, 2026

Drug profile · INN

bupropion hydrochloride

bupropion hydrochloride (BUPROPION HYDROCHLORIDE) is a dopamine transporter inhibitor. Associated with Axsome Therapeutics. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 7
Pipeline programs 5
News articles 6
Drug details — bupropion hydrochloride

Quick answer

bupropion hydrochloride (BUPROPION HYDROCHLORIDE) is a dopamine transporter inhibitor. Associated with Axsome Therapeutics. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN bupropion hydrochloride
Brand BUPROPION HYDROCHLORIDE
Mechanism Dopamine transporter inhibitor
Target Sodium-dependent dopamine transporter
Route ORAL
Formulation TABLET

Mechanism of action

Dopamine transporter inhibitor

Primary target: Sodium-dependent dopamine transporter

Approval history

Authority Status Date
FDA approved

Recent coverage

FDA Approves Auvelity: A New Option for MDD
Critical impact NewsMajor Depressive Disorder (MDD)May 4, 2026

FDA Approves Auvelity: A New Option for MDD

FDA · Major Depressive Disorder (MDD) · 5 min

The FDA has approved Auvelity, a new oral antidepressant combining bupropion and dextromethorphan, for the treatment of major depressive disorder (MDD) in adults. Manufactured by Axsome Therapeutics, this approval marks a significant advancement in MDD treatment options.

Dr. Hannah O'Connor
FDA Approves Auvelity for MDD: A New Antidepressant Option
Critical impact NewsMajor Depressive DisorderMay 3, 2026

FDA Approves Auvelity for MDD: A New Antidepressant Option

FDA · Major Depressive Disorder · 6 min

The FDA has granted approval for Auvelity, a new oral medication for major depressive disorder (MDD) in adults. This approval introduces a novel treatment option with a distinct mechanism of action and a reported rapid onset of therapeutic effect.

Matteo Ricci
Auvelity FDA Approval: New Hope for MDD Patients
Critical impact NewsMajor Depressive Disorder (MDD)May 3, 2026

Auvelity FDA Approval: New Hope for MDD Patients

FDA · Major Depressive Disorder (MDD) · 6 min

The FDA has approved Auvelity, a groundbreaking oral antidepressant from Axsome Therapeutics, marking a significant advancement in treating major depressive disorder (MDD). This approval introduces a novel mechanism of action for patients seeking effective relief.

Charlotte Meyer
Auvelity FDA Approval: New MDD Treatment Option
High impact AnalysisMajor Depressive Disorder (MDD)May 3, 2026

Auvelity FDA Approval: New MDD Treatment Option

FDA · Major Depressive Disorder (MDD) · 12 min

The FDA has approved Auvelity, a new oral treatment for major depressive disorder (MDD) in adults, marking a significant advancement in mental health therapeutics. Manufactured by Axsome Therapeutics, this approval offers a novel option for patients seeking relief from MDD.

Dr. Hannah O'Connor

Pipeline programs

  1. BUPRO-05-25 Phase 1 · Anaxis Pharma · Seasonal affective disorder, Major depressive disorder
  2. BUPRO-06-25 Phase 1 · Anaxis Pharma · Seasonal affective disorder, Major depressive disorder
  3. BUPRO-07-24 Phase 1 · Anaxis Pharma · major depressive illness
  4. BUPRO-08-24 Phase 1 · Anaxis Pharma · major depressive illness
  5. zyban Approved · BRIGHT MINDS BIOSCIENCES · Smoking Cessation

Related & competitor drugs

  1. amphetamine adipate Dopamine transporter releasing agent
  2. amphetamine aspartate Norepinephrine transporter releasing agent
  3. amphetamine sulfate Norepinephrine transporter releasing agent
  4. armodafinil Dopamine transporter inhibitor
  5. dexmethylphenidate hydrochloride Norepinephrine transporter inhibitor
  6. dextroamphetamine sulfate Norepinephrine transporter releasing agent
  1. US 12357697

    Pharmaceutical compositions comprising bupropion and cysteine

    Expires Mon Jul 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12268693

    Pharmaceutical compositions comprising a tolfenamic acid

    Expires Mon Apr 03 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12156914

    Pharmaceutical compositions comprising bupropion and cysteine

    Expires Mon Nov 28 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11780805

    Carbamoyl phenylalaninol compounds and uses thereof

    Expires Mon Oct 05 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11129826

    Bupropion as a modulator of drug activity

    Expires Mon Sep 23 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11123344

    Bupropion as a modulator of drug activity

    Expires Mon Sep 16 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 6306436

    Stabilized, acid-free formulation for sustained release of bupropion hydrochloride

    Expires Mon Oct 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is bupropion hydrochloride?

bupropion hydrochloride (BUPROPION HYDROCHLORIDE) is a dopamine transporter inhibitor. Associated with Axsome Therapeutics. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for bupropion hydrochloride?

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

What is the US approval status of bupropion hydrochloride?

bupropion 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.