WELLBUTRIN Drug Patent Profile

When do Wellbutrin patents expire, and when can generic versions of Wellbutrin launch?

Wellbutrin is a drug marketed by Glaxosmithkline and Bausch and is included in three NDAs.

The generic ingredient in WELLBUTRIN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Wellbutrin

A generic version of WELLBUTRIN was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7^th, 2000.

Summary for WELLBUTRIN

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	84
Patent Applications:	4,365
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for WELLBUTRIN
Drug Sales Revenues:	Drug sales revenues for WELLBUTRIN
What excipients (inactive ingredients) are in WELLBUTRIN?	WELLBUTRIN excipients list
DailyMed Link:	WELLBUTRIN at DailyMed

See drug prices for WELLBUTRIN

See drug sales revenues for WELLBUTRIN

Recent Clinical Trials for WELLBUTRIN

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

Sponsor	Phase
Mclean Hospital	Phase 4
National Cancer Institute (NCI)	Phase 4
Kenya Medical Research Institute	Phase 4

See all WELLBUTRIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for WELLBUTRIN

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for WELLBUTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985		DISCN	Yes	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	AB1	RX	Yes	Yes
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996		DISCN	No	No
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-001	Aug 28, 2003	AB3	RX	Yes	No
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985		DISCN	Yes	No
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985		DISCN	Yes	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996	AB1	RX	Yes	No

Expired US Patents for WELLBUTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985

International Patents for WELLBUTRIN

See the table below for patents covering WELLBUTRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S59112948	CHOLESTEROL LEVEL LOWERING AGENT
Czechoslovakia	209466	METHOD OF MAKING THE ALPHA-ALKYLAMINOPROPIOPHENON DERIVATIVES
Australia	558410
Australia	8365982
Ireland	55181	TREATMENT OF MINIMAL BRAIN DYSFUNCTION(MBD)
Norway	131127
France	2081326

Supplementary Protection Certificates for WELLBUTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	C201730057	Spain		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		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		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
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: 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	CR 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330