Bupropion Hydrochloride

Treats major depressive disorder (MDD). Sold as Wellbutrin, Wellbutrin Sr, Zyban, Wellbutrin Xl, Forfivo Xl. Every FDA application for this active ingredient: 5 branded and 64 generic.

As of Nov 15, 2026, FDA lists 69 applications for Bupropion Hydrochloride (sold as Wellbutrin, Wellbutrin Sr, Zyban and others), first approved Dec 30, 1985, with 5 new uses approved and 0 published complete response letters.

First approved: Dec 30, 1985
Applications: 69
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $326M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Bupropion XL	Part D	$173M	+3%	1,627,090
Wellbutrin XL	Part D	$90.5M	+10%	3,191
Bupropion HCl SR	Part D	$41.1M	-11%	553,027
Bupropion HCl	Part D	$16.3M	-5%	181,732
Wellbutrin SR	Part D	$4.8M	-7%	1,256
Forfivo XL	Part D	$117K	-51%	57

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BUPROPION HCL 100 MG TABLET: $0.116 per unitGeneric · -5% in a year
BUPROPION HCL 75 MG TABLET: $0.095 per unitGeneric · -4% in a year
BUPROPION HCL SR 100 MG TABLET: $0.070 per unitGeneric · +10% in a year
BUPROPION HCL SR 150 MG TABLET: $0.081 per unitGeneric · +1% in a year
BUPROPION HCL SR 200 MG TABLET: $0.104 per unitGeneric · -1% in a year
BUPROPION HCL XL 150 MG TABLET: $0.078 per unitGeneric · -19% in a year
BUPROPION HCL XL 300 MG TABLET: $0.098 per unitGeneric · -32% in a year
BUPROPION HCL XL 450 MG TABLET: $8.10 per unitGeneric · +1% in a year
WELLBUTRIN SR 100 MG TABLET: $7.07 per unitBrand · +1% in a year
WELLBUTRIN SR 150 MG TABLET: $7.52 per unitBrand · 0% in a year
WELLBUTRIN SR 200 MG TABLET: $13.99 per unitBrand · +0% in a year

Clinical Trials

56 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Study of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Jiangsu Simcere Pharmaceutical Co., Ltd.	Phase 1	Not yet recruiting	Nov 3, 2026
A Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult SubjectsHealthy Adult Participants · Basilea Pharmaceutica	Phase 1	Recruiting	Oct 19, 2026
Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation TrialTobacco Use Disorder/Cigarette Smoking, HIV · Yale University	Phase 4	Not yet recruiting	Sep 23, 2026
Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1sObesity & Overweight, Cardiometabolic Health Indicators · Jing Luo	Phase 4	Not yet recruiting	Sep 21, 2026
The BAARD Study : Evaluating a Computerized Approach to Treatment Selection in Older Adults With Treatment Resistant Depression.Late Life Treatment Resistant Depression, Depression - Major Depressive Disorder · Washington University School of Medicine	Phase 2	Not yet recruiting	Sep 9, 2026
Lifestyle Changes, Mushroom Supplementation, and Bupropion to Reduce Adiposity and Cardiometabolic RiskCardiometabolic Syndrome, Obesity and Cardiovascular Risk · Uppsala University	Phase 3	Not yet recruiting	Sep 8, 2026
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)Smoking Cessation · Axsome Therapeutics, Inc.	Phase 3	Recruiting	Aug 14, 2026
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy ParticipantsHealthy Volunteers · Eisai Inc.	Phase 1	Recruiting	Aug 14, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 30, 1985	WellbutrinNDA 18644 · New molecular entity	Glaxosmithkline	53	Discontinued
Oct 4, 1996	Wellbutrin SrNDA 20358 · New dosage form	Glaxosmithkline	59	Marketed
May 14, 1997	ZybanNDA 20711 · New dosage form	Glaxosmithkline	42	Discontinued
Nov 29, 1999	Bupropion HydrochlorideANDA 75310	Heritage Pharma	22	Discontinued
Feb 7, 2000	Bupropion HydrochlorideANDA 75584	Pharmazone	25	Marketed
Apr 17, 2000	Bupropion HydrochlorideANDA 75491	Aurobindo Pharma USA	25	Marketed
Oct 10, 2000	Bupropion HydrochlorideANDA 75613	Invatech	0	Discontinued
Aug 28, 2003	Wellbutrin XlNDA 21515 · New dosage form	Bausch	27	Marketed
Nov 25, 2003	Bupropion HydrochlorideANDA 75932	Epic Pharma LLC	30	Marketed
Jan 28, 2004	Bupropion HydrochlorideANDA 75913	Impax Labs	13	Marketed
May 27, 2004	Bupropion HydrochlorideANDA 75914	Impax Labs	11	Marketed
Dec 3, 2004	Bupropion HydrochlorideANDA 76711	Impax Labs	20	Discontinued
Jul 14, 2005	Bupropion HydrochlorideANDA 76834	Chartwell Rx	6	Discontinued
Jul 14, 2005	Bupropion HydrochlorideANDA 76845	Sandoz	3	Discontinued
Jan 17, 2006	Bupropion HydrochlorideANDA 76143	Apotex	22	Marketed
Dec 14, 2006	Bupropion HydrochlorideANDA 77284	Ph Health	15	Discontinued
Dec 15, 2006	Bupropion HydrochlorideANDA 77415	Impax Labs	19	Discontinued
Jun 13, 2007	Bupropion HydrochlorideANDA 77715	Actavis Labs Fl Inc	15	Marketed
Mar 12, 2008	Bupropion HydrochlorideANDA 77455	Watson Labs Inc	10	Discontinued
Mar 12, 2008	Bupropion HydrochlorideANDA 77475	Sandoz	13	Marketed
Aug 15, 2008	Bupropion HydrochlorideANDA 77285	Watson Labs Inc	15	Marketed
Mar 24, 2009	Bupropion HydrochlorideANDA 79094	Actavis Labs Fl Inc	13	Marketed
Mar 24, 2009	Bupropion HydrochlorideANDA 79095	Actavis Labs Fl Inc	15	Marketed
Apr 6, 2010	Bupropion HydrochlorideANDA 78866	Sun Pharm	11	Discontinued
Apr 8, 2010	Bupropion HydrochlorideANDA 90325	Aurobindo Pharma USA	12	Marketed
May 3, 2010	Bupropion HydrochlorideANDA 90941	Rising	8	Discontinued
Jul 14, 2010	Bupropion HydrochlorideANDA 90942	Aurobindo Pharma USA	4	Discontinued
Jun 9, 2011	Bupropion HydrochlorideANDA 91459	Ph Health	7	Discontinued
Jun 9, 2011	Bupropion HydrochlorideANDA 91520	Ph Health	6	Discontinued
Nov 10, 2011	Forfivo XlNDA 22497 · New dosage form	Twi Pharms	6	Marketed
Aug 30, 2012	Bupropion HydrochlorideANDA 201331	Wockhardt Ltd	2	Discontinued
Nov 21, 2012	Bupropion HydrochlorideANDA 202189	Wockhardt Ltd	1	Marketed
Oct 11, 2013	Bupropion HydrochlorideANDA 202774	Jubilant Generics	2	Discontinued
Oct 11, 2013	Bupropion HydrochlorideANDA 202775	Jubilant Generics	6	Discontinued
Jan 17, 2014	Bupropion HydrochlorideANDA 201567	Zydus Pharms	9	Marketed
Oct 31, 2014	Bupropion HydrochlorideANDA 203969	Torrent	2	Discontinued
Dec 18, 2014	Bupropion HydrochlorideANDA 200695	Sun Pharm	3	Discontinued
May 26, 2015	Bupropion HydrochlorideANDA 202304	Prinston	8	Marketed
Feb 9, 2016	Bupropion HydrochlorideANDA 206674	Invagen Pharms	4	Discontinued
Mar 1, 2016	Bupropion HydrochlorideANDA 205794	Sciegen Pharms	7	Marketed
Aug 17, 2016	Bupropion HydrochlorideANDA 206122	Sciegen Pharms	6	Marketed
Aug 19, 2016	Bupropion HydrochlorideANDA 206975	Heritage Pharma	7	Marketed
Aug 26, 2016	Bupropion HydrochlorideANDA 206556	Invagen Pharms	5	Discontinued
Apr 6, 2017	Bupropion HydrochlorideANDA 90693	Lupin	7	Marketed
Apr 12, 2017	Bupropion HydrochlorideANDA 207479	Sciegen Pharms	2	Marketed
Jun 30, 2017	Bupropion HydrochlorideANDA 207224	Anbison Lab	5	Marketed
Jun 30, 2017	Bupropion HydrochlorideANDA 207459	Jubilant Generics	2	Discontinued
Aug 21, 2017	Bupropion HydrochlorideANDA 208652	Sinotherapeutics Inc	5	Marketed
Sep 18, 2017	Bupropion HydrochlorideANDA 207389	Invagen Pharms	5	Discontinued
Nov 3, 2017	Bupropion HydrochlorideANDA 210081	Twi Pharms	3	Discontinued
Jun 8, 2018	Bupropion HydrochlorideANDA 203013	Alembic	6	Marketed
Jun 14, 2018	Bupropion HydrochlorideANDA 210015	Yichang Humanwell	7	Marketed
Oct 16, 2018	Bupropion HydrochlorideANDA 211347	Yichang Humanwell	8	Marketed
Oct 31, 2018	Bupropion HydrochlorideANDA 210497	Accord Hlthcare	3	Marketed
Jan 28, 2019	Bupropion HydrochlorideANDA 211020	Graviti Pharms	7	Marketed
Sep 5, 2019	Bupropion HydrochlorideANDA 211200	Zhejiang Jutai Pharm	4	Marketed
Jan 16, 2020	Bupropion HydrochlorideANDA 208606	Cadila Pharms Ltd	4	Marketed
Apr 17, 2020	Bupropion HydrochlorideANDA 207403	Micro Labs	6	Discontinued
Nov 30, 2020	Bupropion HydrochlorideANDA 200216	Sun Pharm	3	Discontinued
Dec 31, 2020	Bupropion HydrochlorideANDA 203650	Sun Pharm	2	Discontinued
Feb 2, 2022	Bupropion HydrochlorideANDA 215568	Granules	2	Marketed
Jan 9, 2023	Bupropion HydrochlorideANDA 216766	Yichang Humanwell	4	Marketed
May 31, 2023	Bupropion HydrochlorideANDA 216800	Annora Pharma	1	Marketed
Oct 17, 2024	Bupropion HydrochlorideANDA 218385	Granules	0	Marketed
May 2, 2025	Bupropion HydrochlorideANDA 207874	Ipca Labs Ltd	0	Marketed
Oct 1, 2025	Bupropion HydrochlorideANDA 217898	Annora Pharma	0	Marketed
May 4, 2026	Bupropion HydrochlorideANDA 220529	Yichang Humanwell	0	Marketed
Jun 23, 2026	Bupropion HydrochlorideANDA 218567	Macleods Pharms	0	Marketed
Jul 21, 2026	Bupropion HydrochlorideANDA 216051	Aurobindo Pharma Ltd	0	Marketed

Show all 69

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA