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Last Updated: March 29, 2020

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ZYBAN Drug Profile


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When do Zyban patents expire, and what generic alternatives are available?

Zyban is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in ZYBAN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Additional details are available on the bupropion hydrochloride profile page.

Drug patent expirations by year for ZYBAN
Drug Prices for ZYBAN

See drug prices for ZYBAN

Recent Litigation for ZYBAN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.2013-05-17
Purdue Pharma LP v. Sandoz Inc.2012-10-10
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.2012-07-20

See all ZYBAN litigation

Synonyms for ZYBAN
.alpha.-(tert-Butylamino)-m-chloropropiophenone
( -)-2-(tert-Butylamino)-3'-chloropropiophenone
( -)-2-(tert-Butylamino)-3'-chlorpropiophenon
( inverted question mark)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride
(.+-.)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride
(.+/-.)-2-(tert-Butylamino)-3'-chloropropiophenone
(.+/-.)-Bupropion
(+-)-1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone
(+-)-2-(tert-Butylamino)-3'-chloropropiophenone
(+-)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride
(+-)-2-(tert-Butylamino)-3'-chlorpropiophenon
(+-)-alpha-tert-Butylamino-3-chloropropiophenone hydrochloride
(+-)-Bupropion
(+/-)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride
(+/-)-2-(t-butylamino)-3'-chloropropiophenone hydrochloride
01ZG3TPX31
1-(3-Chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone
1-(3-CHLOROPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-1-PROPANONE HYDROCHLORIDE
1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]propan-1-one
1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-
1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, (.+/-.)-
1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, (+-)-
1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, hydrochloride, (+-)-
1-Propanone, 1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl)amino]-
1-Propanone,1-dimethylethyl)amino]-, hydrochloride, (.+-.)-
2-(tert-Butylamino)-1-(3-chlorophenyl)-1-propanone #
2-(tert-Butylamino)-1-(3-chlorophenyl)-1-propanone Hydrochloride
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one HCl
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one hydrochloride
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one;hydrochloride
2-(Tert-Butylamino)-3'-chloropropiophenone
2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride
2-tert-Butylamino-1-(3-chlorophenyl)propan-1-one
3'-Chloro-alpha-(tert-butylamino)propiophenone
31677-93-7
34841-36-6
34841-39-9
34911-55-2
4CH-007122
77B937
8068AH
A820950
AB00053756
AB00053756_20
AB00053756_21
AB00053756-16
AB00053756-18
AB00053756-19
AB0012179
AB02273
AB2000567
AC-196
AC-197
ACM34841366
ACM34841399
ACM34911552
AK-34646
AK-75760
AKOS015844544
AKOS015961770
alpha-(tert-butylamino)-m-chloropropiophenone
alpha-(tert-Butylamino)-m-chloropropiophenone hydrochloride
AM20060780
AM807634
Amfebutamon
Amfebutamon hydrochlorid
Amfebutamon hydrochloride
Amfebutamona
Amfebutamona [INN-Spanish]
Amfebutamone
Amfebutamone (Bupropion)
Amfebutamone (Bupropion) HCl
AMFEBUTAMONE HCl
Amfebutamone hydrochloride
Amfebutamone-hydrochloride(Bupropion)
Amfebutamone(Bupropion)
amfebutamonum
Amfebutamonum [INN-Latin]
ANW-42367
API0001440
API0008795
AX8020179
AX8118984
B-102
B3649
BBL029065
BCP0726000049
BCP22394
BCP24193
BCP9000462
BDBM50048392
BG0117
BPBio1_000042
BRD-A05186015-003-05-7
BRD-A05186015-003-09-9
BRN 2101062
BSPBio_000038
BSPBio_002247
Budeprion
Budeprion (Salt/Mix)
Budeprion XL
Budeprion XL 300
bupropion
bupropion (amfebutamone)
Bupropion (hydrochloride)
Bupropion (INN)
Bupropion (USAN)
Bupropion [INN:BAN]
Bupropion Hcl
Bupropion hydrochloride
Bupropion hydrochloride (JAN/USP)
Bupropion hydrochloride [USAN:USP:JAN]
Bupropion hydrochloride [USAN:USP]
Bupropion Hydrochloride 1.0 mg/ml in Methanol (as free base)
Bupropion hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Bupropion hydrochloride, >=98% (HPLC), solid
Bupropion Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Bupropion hydrochloride, United States Pharmacopeia (USP) Reference Standard
Bupropion hydrocloride
Bupropion SR
BVF 033
BW 322U
BW 323
BW-323
BW-323U66
C-6222
C06860
CAS-31677-93-7
CCG-100858
CCG-100911
CCG-204261
CCG-39085
CHEBI:3219
CHEBI:3220
CHEMBL1698
CHEMBL894
CPD000058423
CPD000472526
CPI-300
CS-2503
CTK8B3357
D00817
D07591
DB-048697
DB01156
DivK1c_007050
DSSTox_CID_24561
DSSTox_GSID_44561
DSSTox_RID_80314
DTXSID6044561
DTXSID7022706
EINECS 250-759-9
EINECS 252-243-9
Elontril
EU-0100166
Forfivo XL
FT-0081218
FT-0623288
FT-0630586
GTPL7135
HEYVINCGKDONRU-UHFFFAOYSA-N
HMS1568B20
HMS1922F09
HMS2051G10
HMS2089G14
HMS2232P04
HMS3369P11
HMS3393G10
HSDB 6988
HY-B0403A
J10311
KBio1_001994
KBio2_002143
KBio2_004711
KBio2_007279
KBio3_001467
KBioGR_001168
KBioSS_002143
KS-00000XL2
KS-1034
L000725
Lopac0_000166
LP00166
LS-122817
LS-125089
M-5146
m-Chloro-alpha-tert-butylaminopropionphenone hydrochloride
m-Chloro-alpha-tert-butylaminopropiophenone hydrochloride
MFCD00055209
MLS000069376
MLS001401370
MLS001424015
MLS002320678
MRF-0000143
NC00108
NC00161
NCGC00015122-03
NCGC00015122-04
NCGC00015122-06
NCGC00015122-07
NCGC00015122-09
NCGC00015122-11
NCGC00015122-14
NCGC00016807-01
NCGC00089751-02
NCGC00093650-01
NCGC00093650-02
NCGC00093650-03
NCGC00093650-04
NCGC00093650-05
NCGC00180895-01
NCGC00180895-02
NCGC00255927-01
NCGC00260851-01
NCI60_002714
NSC 315851
NSC-315851
NSC-758686
NSC315851
NSC758686
Pharmakon1600-01504174
Prestwick_668
Prestwick0_000249
Prestwick1_000249
Prestwick2_000249
Prestwick3_000249
Propiophenone, 2-(tert-butylamino)-3'-chloro-
Propiophenone, 2-(tert-butylamino)-3'-chloro-, hydrochloride, (+-)-
Propiophenone, hydrochloride, (.+-.)-
PubChem20752
Q27295463
Q834280
Quomem
S2452
SAM001246699
SAM001246723
SBI-0050154.P003
SC-12179
SCHEMBL38777
SCHEMBL41602
SMR000058423
SMR000472526
SMR001338824
SNPPWIUOZRMYNY-UHFFFAOYSA-N
SPBio_001817
SPBio_002257
SpecPlus_000954
Spectrum_001663
SPECTRUM1504174
Spectrum2_001659
Spectrum3_000644
Spectrum4_000614
Spectrum5_001406
SR-01000002989
SR-01000002989-10
SR-01000002989-2
ST24027672
STL373006
SW196823-6
TC-010273
Tox21_110621
Tox21_110621_1
Tox21_301844
Tox21_500166
UNII-01ZG3TPX31
V2047
Voxra
Wellbatrin
Wellbutrin
Wellbutrin (Salt/Mix)
Wellbutrin (TN)
Wellbutrin Retard
Wellbutrin SR
Wellbutrin XL
Wellbutrin XR
Wellbutrin;Zyban;Voxra;Budeprion;Aplenzin;Bupropion
Zyban (pharmaceutical)
Zyban (Salt/Mix)
Zyban (TN)
Paragraph IV (Patent) Challenges for ZYBAN
Tradename Dosage Ingredient NDA Submissiondate
ZYBAN TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020711

US Patents and Regulatory Information for ZYBAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZYBAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997   Start Trial   Start Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997   Start Trial   Start Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997   Start Trial   Start Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZYBAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 17C1058 France   Start Trial PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 1790064-8 Sweden   Start Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
2316456 2017C/064 Belgium   Start Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0467488 SPC/GB00/019 United Kingdom   Start Trial PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Baxter
McKinsey
Moodys
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.