Wellbutrin, Mysimba(bupropion)

Aplenzin, Auvelity, Contrave, Forfivo, Mysimba, Wellbutrin (bupropion) is a small molecule pharmaceutical. Bupropion was first approved as Wellbutrin on 1985-12-30. It is used to treat attention deficit disorder with hyperactivity, depressive disorder, and tobacco use disorder in the USA. It has been approved in Europe to treat obesity and overweight. The pharmaceutical is active against sodium-dependent dopamine transporter and sodium-dependent noradrenaline transporter.

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Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750
signs and symptoms pathological conditions	D013568
chemically-induced disorders	D064419
diagnosis	D003933
mental disorders	D001523
physiological phenomena	D010829

Trade Name

FDA

EMA

Aplenzin, Forfivo, Wellbutrin (generic drugs available since 2000-02-07, discontinued: Zyban)

Combinations

Auvelity, Contrave

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Bupropion hydrobromide

Tradename	Company	Number	Date	Products
APLENZIN	Bausch Health Companies	N-022108 RX	2008-04-23	3 products, RLD, RS

Bupropion hydrochloride

Tradename	Company	Number	Date	Products
FORFIVO XL	Almatica Pharma	N-022497 RX	2011-11-10	1 products, RLD, RS
WELLBUTRIN XL	Bausch Health Companies	N-021515 RX	2003-08-28	2 products, RLD, RS
WELLBUTRIN SR	GSK	N-020358 RX	1996-10-04	3 products, RLD

Show 3 discontinued

Bupropion hydrochloride

Dextromethorphan hydrobromide

Tradename	Company	Number	Date	Products
AUVELITY	Axsome Malta	N-215430 RX	2022-08-18	1 products, RLD, RS

Bupropion hydrochloride

Naltrexone hydrochloride

Tradename	Company	Number	Date	Products
CONTRAVE	Nalpropion Pharmaceuticals	N-200063 RX	2014-09-10	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
aplenzin	New Drug Application	2021-07-13
auvelity	New Drug Application	2022-09-02
bupropion hydrochloride	ANDA	2023-06-20
contrave	New Drug Application	2021-11-04
forfivo	New Drug Application	2019-12-31
wellbutrin	New Drug Application	2020-10-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
attention deficit disorder with hyperactivity	EFO_0003888	D001289	F90
depressive disorder	EFO_1002014	D003866	F32.A
tobacco use disorder	—	D014029	F17

Agency Specific

FDA

EMA

Expiration	Code
BUPROPION HYDROCHLORIDE / DEXTROMETHORPHAN HYDROBROMIDE, AUVELITY, AXSOME
2025-08-18	NP

Patent Expiration

Patent	Expires	Flag	FDA Information
Bupropion Hydrochloride / Dextromethorphan Hydrobromide, Auvelity, Axsome
10780064	2040-01-07		U-3419
10925842	2040-01-07		U-3419
10940124	2040-01-07		U-3419
10966942	2040-01-07		U-3419
10780066	2034-11-09		U-3419
9168234	2034-11-05		U-3419
9198905	2034-11-05		U-3419
9205083	2034-11-05		U-3419
9238032	2034-11-05		U-3419
9278095	2034-11-05		U-3419
9314462	2034-11-05		U-3419
9370513	2034-11-05		U-3419
9375429	2034-11-05		U-3419
9408815	2034-11-05		U-3419
9421176	2034-11-05		U-3419
9457023	2034-11-05		U-3419
9457025	2034-11-05		U-3419
9474731	2034-11-05		U-3419
9486450	2034-11-05		U-3419
9700528	2034-11-05		U-3419
9700553	2034-11-05		U-3419
9707191	2034-11-05		U-3419
9763932	2034-11-05		U-3419
9861595	2034-11-05		U-3419
9867819	2034-11-05		U-3419
9968568	2034-11-05		U-3419
10058518	2034-11-05		U-3419
10064857	2034-11-05		U-3419
10080727	2034-11-05		U-3419
10092560	2034-11-05		U-3419
10092561	2034-11-05		U-3419
10105327	2034-11-05		U-3419
10105361	2034-11-05		U-3419
10251879	2034-11-05		U-3419
10463634	2034-11-05		U-3419
10512643	2034-11-05		U-3419
10548857	2034-11-05		U-3419
10596167	2034-11-05		U-3419
10772850	2034-11-05		U-3419
10786469	2034-11-05		U-3419
10786496	2034-11-05		U-3419
10799497	2034-11-05		U-3419
10806710	2034-11-05		U-3419
10864209	2034-11-05		U-3419
10874663	2034-11-05		U-3419
10874664	2034-11-05		U-3419
10874665	2034-11-05		U-3419
10881624	2034-11-05		U-3419
10881657	2034-11-05		U-3419
10894046	2034-11-05		U-3419
10894047	2034-11-05		U-3419
10898453	2034-11-05		U-3419
10933034	2034-11-05		U-3419
10945973	2034-11-05		U-3419
10966941	2034-11-05		U-3419
10966974	2034-11-05		U-3419
11020389	2034-11-05		U-3419
11058648	2034-11-05		U-3419
11090300	2034-11-05		U-3419
11096937	2034-11-05		U-3419
11123343	2034-11-05		U-3419
11129826	2034-11-05		U-3419
11141388	2034-11-05		U-3419
11141416	2034-11-05		U-3419
11147808	2034-11-05		U-3419
11185515	2034-11-05		U-3419
11191739	2034-11-05	DP	U-3419
11197839	2034-11-05	DP	U-3419
11207281	2034-11-05		U-3419
11213521	2034-11-05		U-3419
11229640	2034-11-05		U-3419
11234946	2034-11-05		U-3419
11253491	2034-11-05		U-3419
11253492	2034-11-05		U-3419
11273133	2034-11-05		U-3419
11273134	2034-11-05		U-3419
11285118	2034-11-05		U-3419
11285146	2034-11-05		U-3419
11291638	2034-11-05		U-3419
11291665	2034-11-05		U-3419
11298351	2034-11-05		U-3419
11298352	2034-11-05		U-3419
11311534	2034-11-05		U-3419
11344544	2034-11-05		U-3419
11357744	2034-11-05		U-3419
11364233	2034-11-05		U-3419
11382874	2034-11-05		U-3419
11419867	2034-11-05		U-3419
11426370	2034-11-05		U-3419
11426401	2034-11-05		U-3419
11433067	2034-11-05	DP	U-3419
11439636	2034-11-05		U-3419
11478468	2034-11-05		U-3419
11497721	2034-11-05		U-3419
11510918	2034-11-05		U-3419
11517542	2034-11-05		U-3419
11517543	2034-11-05		U-3419
11524007	2034-11-05		U-3419
11524008	2034-11-05		U-3419
11534414	2034-11-05	DP	U-3419
11541021	2034-11-05		U-3419
11541048	2034-11-05		U-3419
11596627	2034-11-05		U-3419
11617728	2034-11-05		U-3419
11617747	2034-11-05		U-3563
8569328	2033-10-29	DP	U-3419
Bupropion Hydrochloride / Naltrexone Hydrochloride, Contrave, Nalpropion
10231964	2034-07-02		U-1583
10828294	2034-07-02		U-1583
10835527	2034-07-02		U-1583
9633575	2033-06-25		U-1583
10403170	2033-06-05		U-1583
11139056	2033-06-05		U-1583
9248123	2032-01-13		U-1808
11033543	2031-01-10		U-1583
8916195	2030-02-02		U-1639
11324741	2029-05-29		U-1583
8088786	2029-02-03	DP
8318788	2027-11-08		U-1584
8722085	2027-11-08		U-1585
9125868	2027-11-08		U-1585
10307376	2027-11-08		U-1585
9107837	2027-06-04		U-1639
7375111	2025-03-26	DP
7462626	2024-07-20		U-1583
8815889	2024-07-20		U-1586
11278544	2024-04-21		U-1583
Bupropion Hydrochloride, Forfivo Xl, Almatica
7674479	2027-06-25	DP
Bupropion Hydrobromide, Aplenzin, Bausch
7241805	2026-06-27	DP
7569610	2026-06-27		U-997
7572935	2026-06-27	DP
7585897	2026-06-27	DP
7645802	2026-06-27	DP
7649019	2026-06-27	DP
7662407	2026-06-27	DP
7671094	2026-06-27	DP

ATC Codes

A: Alimentary tract and metabolism drugs

— A08: Antiobesity preparations, excl. diet products

— A08A: Antiobesity preparations, excl. diet products

— A08AA: Centrally acting antiobesity products

— A08AA62: Bupropion and naltrexone

N: Nervous system drugs

— N06: Psychoanaleptics

— N06A: Antidepressants

— N06AX: Other antidepressants in atc

— N06AX12: Bupropion

HCPCS

Code	Description
S0106	Bupropion hcl sustained release tablet, 150 mg, per bottle of 60 tablets

Clinical

Clinical Trials

325 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Tobacco use disorder	D014029		F17	5	17	13	21	7	57
Major depressive disorder	D003865	EFO_0003761	F22	4	6	10	20	2	41
Smoking cessation	D016540	EFO_0004319		—	7	10	11	5	32
Depression	D003863		F33.9	4	3	5	11	3	24
Obesity	D009765	EFO_0001073	E66.9	—	10	10	8	1	24
Healthy volunteers/patients	—			20	—	—	2	1	23
Smoking	D012907	EFO_0003768	F17	3	5	5	7	5	22
Schizophrenia	D012559	EFO_0000692	F20	—	4	1	8	1	14
Depressive disorder	D003866	EFO_1002014	F32.A	3	2	3	1	3	12
Bipolar disorder	D001714	EFO_0000289	F30.9	1	2	1	3	3	9

Show 47 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369		C80	3	—	1	—	3	7
Overweight	D050177		E66.3	—	1	4	—	1	6
Binge-eating disorder	D056912		F50.2	—	5	5	—	1	6
Cocaine-related disorders	D019970		F14	2	3	2	—	1	6
Alzheimer disease	D000544	EFO_0000249	F03	1	1	2	—	—	3
Acute coronary syndrome	D054058	EFO_0005672		1	1	1	—	—	2
Opioid-related disorders	D009293	EFO_0005611	F11	—	1	2	—	—	2
Psychomotor agitation	D011595			—	1	2	—	—	2
Psychological sexual dysfunctions	D020018		F52.0	—	2	1	—	—	2
Psychophysiologic disorders	D011602		F45.9	—	—	1	—	—	1

Show 7 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Marijuana abuse	D002189	EFO_0007191	F12	—	2	—	—	1	3
Amphetamine-related disorders	D019969	EFO_0004701	F15	1	2	—	—	—	3
Non-small-cell lung carcinoma	D002289			1	1	—	—	1	2
Pregnancy	D011247	EFO_0002950	Z33.1	—	1	—	—	1	2
Hiv infections	D015658	EFO_0000764	B20	1	1	—	—	—	2
Chronic renal insufficiency	D051436		N18	—	1	—	—	—	1
Second primary neoplasms	D016609			—	1	—	—	—	1
Anhedonia	D059445		R45.84	—	1	—	—	—	1
Ovarian neoplasms	D010051	EFO_0003893	C56	—	1	—	—	—	1
Vaginal neoplasms	D014625		C52	—	1	—	—	—	1

Show 7 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Squamous cell carcinoma of head and neck	D000077195			1	—	—	—	1	2
Melanoma	D008545			1	—	—	—	—	1
Mitochondrial diseases	D028361	EFO_0000591		1	—	—	—	—	1
Drug interactions	D004347			1	—	—	—	—	1
Prostatic neoplasms	D011471		C61	1	—	—	—	—	1
Nasopharyngeal neoplasms	D009303			1	—	—	—	—	1
Recurrence	D012008			1	—	—	—	—	1
Cognition	D003071	EFO_0003925		1	—	—	—	—	1
Hepatolenticular degeneration	D006527	Orphanet_905	E83.01	1	—	—	—	—	1
B-cell chronic lymphocytic leukemia	D015451		C91.1	1	—	—	—	—	1

Show 3 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Health behavior	D015438			—	—	—	—	1	1
Periodontitis	D010518	EFO_0000649	K05.3	—	—	—	—	1	1
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	—	—	—	—	1	1
Gambling	D005715		F63.0	—	—	—	—	1	1
Pulmonary tuberculosis	D014397	EFO_1000049	A15	—	—	—	—	1	1
Breast feeding	D001942			—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	BUPROPION
INN	bupropion
Description	Bupropion is an aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring. It has a role as an antidepressant, an environmental contaminant and a xenobiotic. It is a secondary amino compound, a member of monochlorobenzenes and an aromatic ketone.
Classification	Small molecule
Drug class	Antidepressants
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1

Identifiers

PDB	—
CAS-ID	34911-55-2
RxCUI	42347
ChEMBL ID	CHEMBL894
ChEBI ID	3219
PubChem CID	444
DrugBank	DB01156
UNII ID	01ZG3TPX31 (ChemIDplus, GSRS)

Target

Agency Approved

SLC6A3

SLC6A2

Organism

Homo sapiens

Gene name

SLC6A3

Gene synonyms

DAT1

NCBI Gene ID

6531

Protein name

sodium-dependent dopamine transporter

Protein synonyms

DA transporter, dopamine transporter 1, solute carrier family 6 (neurotransmitter transporter), member 3, solute carrier family 6 (neurotransmitter transporter, dopamine), member 3, Solute carrier family 6 member 3

Uniprot ID

Q14996

Mouse ortholog

Slc6a3 (13162)

sodium-dependent dopamine transporter (Q9R1I2)

Alternate

No data

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 16,908 documents

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Safety

Black-box Warning

Black-box warning for: Aplenzin, Auvelity, Bupropion hydrochloride, Contrave, Forfivo , Wellbutrin

Adverse Events

Top Adverse Reactions

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1,053 adverse events reported

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Real-time Data on

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MATERIALS

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