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Generated: May 26, 2019

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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 bupropion hydrochloride 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 Pharma Global, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zydus Pharms Usa Inc, Alvogen, Glaxosmithkline, Valeant Intl, Alembic Pharms Ltd, Apotex Inc, Heritage Pharma, Teva, and Nalpropion, and is included in fifty-six NDAs. There are eleven 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. Eighty-five suppliers are listed for this compound.

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)

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
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 206674-002 Feb 9, 2016 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Graviti Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 211020-002 Jan 28, 2019 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 206556-001 Aug 26, 2016 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077715-001 Nov 26, 2008 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 075914-001 May 27, 2004 AB2 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Twi Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 210081-002 Nov 3, 2017 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Valeant Intl WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for bupropion hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0656775 28/2000 Austria ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456 C201730057 Spain ➤ Sign Up PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456 300918 Netherlands ➤ Sign Up 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 65/2017 Austria ➤ Sign Up PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330
2316456 1790064-8 Sweden ➤ Sign Up 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
0467488 SPC/GB00/019 United Kingdom ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456 122017000109 Germany ➤ Sign Up 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

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