DrugPatentWatch Database Preview

Bupropion hydrochloride - Generic Drug Details

See Plans and Pricing

« 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, 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.

Summary for bupropion hydrochloride

International Patents:	1
US Patents:	13
Tradenames:	7
Applicants:	32
NDAs:	57
Drug Master File Entries:	38
Suppliers / Packagers:	67
Bulk Api Vendors:	104
Clinical Trials:	323
Patent Applications:	1,309
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupropion hydrochloride
DailyMed Link:	bupropion hydrochloride at DailyMed

Recent Clinical Trials for bupropion hydrochloride

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

Sponsor	Phase
University of Minnesota - Clinical and Translational Science Institute	Phase 4
Boston University Charles River Campus	Phase 2
Tobacco Related Disease Research Program	Phase 4

See all bupropion hydrochloride clinical trials

Recent Litigation for bupropion hydrochloride

Identify potential future generic entrants

District Court Litigation

Case Name	Date
INTELGENX CORP. v. WOCKHARDT BIO, AG	2013-08-23
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

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

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
Sinotherapeutics Inc	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208652-001	Aug 21, 2017	AB3	RX	No	No
Invagen Pharms	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	207389-002	Sep 18, 2017	AB	RX	No	No
Actavis Labs Fl Inc	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079094-001	Mar 24, 2009	AB2	RX	No	Yes
Heritage Pharma	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	206975-002	Aug 19, 2016	AB	RX	No	No
Wockhardt Ltd	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202189-001	Nov 21, 2012	AB3	RX	No	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	AB1	RX	Yes	Yes

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
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-002	May 14, 1997
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985

International Patents for bupropion hydrochloride

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for bupropion hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	300918	Netherlands		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		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
0656775	CR 2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	17C1058	France		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		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