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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 patent protection?

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, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, and Nalpropion, and is included in fifty-nine 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-six suppliers are listed for this compound.

Summary for bupropion hydrochloride

International Patents:	1
US Patents:	13
Tradenames:	7
Applicants:	34
NDAs:	59
Drug Master File Entries:	38
Suppliers / Packagers:	66
Bulk Api Vendors:	103
Clinical Trials:	330
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
Oslo University Hospital	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2
Vanderbilt University Medical Center	Phase 2

See all bupropion hydrochloride clinical trials

Pharmacology for bupropion hydrochloride

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

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
Watson Labs Inc	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077455-001	Jul 19, 2010		DISCN	No	No
Heritage Pharma	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	206975-002	Aug 19, 2016	AB	RX	No	No
Anchen Pharms	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091520-001	Jun 9, 2011	AB2	RX	No	No
Sciegen Pharms Inc	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206122-001	Aug 17, 2016	AB2	RX	No	No

Expired US Patents for bupropion hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Intl	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-001	Aug 28, 2003
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	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	2017/059	Ireland		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; REGISTRATION NO/DATE: EU/1/14/988 20150326
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	LUC00054	Luxembourg		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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326