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Last Updated: February 23, 2020

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Bupropion hydrochloride - Generic Drug Details

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What are the generic sources for bupropion hydrochloride and what is the scope of freedom to operate?

Bupropion hydrochloride is the generic ingredient in seven branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Anchen Pharms, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alvogen, Glaxosmithkline, Valeant Intl, Alembic Pharms Ltd, Apnar Pharma Lp, Apotex Inc, Heritage Pharma, Invatech, and Nalpropion, and is included in fifty-seven NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride has one patent family member in one country.

There are thirty-eight drug master file entries for bupropion hydrochloride. Sixty-seven suppliers are listed for this compound.

Recent Clinical Trials for bupropion hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Minnesota - Clinical and Translational Science InstitutePhase 4
Boston University Charles River CampusPhase 2
Tobacco Related Disease Research ProgramPhase 4

See all bupropion hydrochloride clinical trials

Recent Litigation for bupropion hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
INTELGENX CORP. v. WOCKHARDT BIO, AG2013-08-23
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.2013-05-17
Purdue Pharma LP v. Sandoz Inc.2012-10-10

See all bupropion hydrochloride litigation

Pharmacology for bupropion hydrochloride
Synonyms for bupropion hydrochloride
( 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 hydrochloride
(+-)-alpha-tert-Butylamino-3-chloropropiophenone hydrochloride
(+/-)-1-(3-Chlorophenyl)-2- [(1,1-dimethylethyl)amino]- 1-propanone hydrochloride
(+/-)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride
(+/-)-2-(t-butylamino)-3'-chloropropiophenone hydrochloride
1-(3-CHLOROPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-1-PROPANONE HYDROCHLORIDE
1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, hydrochloride, (+-)-
1-Propanone,1-dimethylethyl)amino]-, hydrochloride, (.+-.)-
2-(tert-Butylamino)-1-(3-chlorophenyl)-1-propanone Hydrochloride
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 hydrochloride
31677-93-7
34841-36-6
4CH-007122
77B937
A820950
AB0012179
AB02273
AB2000567
AC-196
AC1L1XZA
ACM34841366
AK-75760
AKOS015844544
alpha-(tert-Butylamino)-m-chloropropiophenone hydrochloride
AM20060780
Amfebutamon hydrochlorid
Amfebutamon hydrochloride
Amfebutamone (Bupropion)
Amfebutamone (Bupropion) HCl
AMFEBUTAMONE HCl
Amfebutamone hydrochloride
Amfebutamone(Bupropion)
AN-16061
ANW-42367
API0001440
AX8118984
B3649
BC208314
BCP0726000049
BCP22394
BCP9000462
BG0117
Budeprion
Budeprion XL
Budeprion XL 300
Bupropion (hydrochloride)
Bupropion Hcl
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
BW 322U; BVF 033; Amfebutamone
BW 323
BW-323
BW-323U66
CAS-31677-93-7
CCG-100911
CCG-39085
CHEBI:3220
CHEMBL1698
CPD000058423
CPI-300
CS-2503
CTK8B3357
D00817
DSSTox_CID_24561
DSSTox_GSID_44561
DSSTox_RID_80314
DTXSID6044561
EINECS 250-759-9
EINECS 252-243-9
Elontril
EU-0100166
Forfivo XL
FT-0081218
FT-0623288
HEYVINCGKDONRU-UHFFFAOYSA-N
HMS1568B20
HMS1922F09
HSDB 6988
HY-B0403A
I06-0019
I06-19
J10311
Jsp005899
KB-224632
KS-00000XL2
KS-1034
LP00166
LS-125089
M-5146
m-Chloro-alpha-tert-butylaminopropionphenone hydrochloride
m-Chloro-alpha-tert-butylaminopropiophenone hydrochloride
MFCD00055209
MLS000069376
MLS001401370
MLS002320678
NC00161
NCGC00015122-11
NCGC00016807-01
NCGC00093650-01
NCGC00093650-02
NCGC00093650-03
NCGC00093650-04
NCGC00093650-05
NCGC00180895-01
NCGC00180895-02
NCGC00255927-01
NCGC00260851-01
NSC 315851
NSC-315851
NSC-758686
NSC315851
NSC758686
Pharmakon1600-01504174
Prestwick_668
Propiophenone, 2-(tert-butylamino)-3'-chloro-, hydrochloride, (+-)-
Propiophenone, hydrochloride, (.+-.)-
PubChem20752
Quomem
S2452
SAM001246723
SC-12179
SCHEMBL41602
SMR000058423
SMR001338824
SPECTRUM1504174
SR-01000002989
SR-01000002989-10
SR-01000002989-2
ST24027672
SW196823-6
TC-010273
Tox21_110621
Tox21_110621_1
Tox21_301844
Tox21_500166
V2047
Voxra
Wellbutrin
Wellbutrin (TN)
Wellbutrin Retard
Wellbutrin SR
Wellbutrin XL
Wellbutrin XR
Wellbutrin;Zyban;Voxra;Budeprion;Aplenzin;Bupropion
Zyban
Zyban (pharmaceutical)
Zyban (TN)
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
FORFIVO XL TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 022497 2013-02-28
WELLBUTRIN XL TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 021515 2004-09-21
ZYBAN TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020711
WELLBUTRIN TABLET;ORAL bupropion hydrochloride 018644
WELLBUTRIN SR TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020358

US Patents and Regulatory Information for bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Generics BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 202774-002 Oct 11, 2013 AB1 RX No No   Start Trial   Start Trial   Start Trial
Sinotherapeutics Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 208652-001 Aug 21, 2017 AB3 RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 207389-002 Sep 18, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 079094-001 Mar 24, 2009 AB2 RX No Yes   Start Trial   Start Trial   Start Trial
Heritage Pharma BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 206975-002 Aug 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Ltd BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 202189-001 Nov 21, 2012 AB3 RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002 AB1 RX Yes Yes   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 bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985   Start Trial   Start Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-001 Oct 4, 1996   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for bupropion hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 300918 Netherlands   Start Trial PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 132017000142109 Italy   Start Trial PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
0656775 CR 2000 00018 Denmark   Start Trial PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Boehringer Ingelheim
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Dow
McKesson

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