WELLBUTRIN Drug Patent Profile
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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 7th, 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 |
Recent Clinical Trials for WELLBUTRIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mclean Hospital | Phase 4 |
Kenya Medical Research Institute | Phase 4 |
National Cancer Institute (NCI) | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for WELLBUTRIN
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-004 | Jun 14, 2002 | AB1 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-001 | Oct 4, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bausch | WELLBUTRIN XL | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021515-001 | Aug 28, 2003 | AB3 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-002 | Dec 30, 1985 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 WELLBUTRIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-003 | Dec 30, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-001 | Dec 30, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-001 | Dec 30, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN | bupropion hydrochloride | TABLET;ORAL | 018644-001 | Dec 30, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for WELLBUTRIN
See the table below for patents covering WELLBUTRIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 302276 | ⤷ Try a Trial | |
Belgium | 759838 | ⤷ Try a Trial | |
Australia | 4531585 | ⤷ Try a Trial | |
Germany | 2064934 | ⤷ Try a Trial | |
South Africa | 7008179 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for WELLBUTRIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0656775 | CR 2000 00018 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
2316456 | 300918 | Netherlands | ⤷ Try a Trial | 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 | C 2017 047 | Romania | ⤷ Try a Trial | 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 |
2316456 | CA 2017 00062 | Denmark | ⤷ Try a Trial | 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 |
2316456 | 2017/059 | Ireland | ⤷ Try a 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; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |