Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Medtronic
Harvard Business School
McKinsey
Baxter

Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Bupropion hydrochloride - Generic Drug Details

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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, 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. Seventy-six 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
University of California, San FranciscoPhase 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
WELLBUTRIN TABLET;ORAL bupropion hydrochloride 018644
WELLBUTRIN SR TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020358
ZYBAN TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020711

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
Alembic Pharms Ltd BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 203013-002 Jun 8, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 207479-002 Apr 12, 2017 AB3 RX No 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 bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 020358-004 Jun 14, 2002   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-002 Oct 4, 1996   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 2017C/064 Belgium   Start Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND 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 122017000109 Germany   Start Trial PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
>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:

Harvard Business School
Colorcon
AstraZeneca
Baxter
Boehringer Ingelheim
McKesson

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 verifification 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.