WELLBUTRIN SR Drug Patent Profile
✉ Email this page to a colleague
When do Wellbutrin Sr patents expire, and when can generic versions of Wellbutrin Sr launch?
Wellbutrin Sr is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in WELLBUTRIN SR 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 Sr
A generic version of WELLBUTRIN SR was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7th, 2000.
Summary for WELLBUTRIN SR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 138 |
Clinical Trials: | 84 |
Patent Applications: | 1,205 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for WELLBUTRIN SR |
DailyMed Link: | WELLBUTRIN SR at DailyMed |
Recent Clinical Trials for WELLBUTRIN SR
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 |
Pharmacology for WELLBUTRIN SR
Drug Class | Aminoketone |
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Anatomical Therapeutic Chemical (ATC) Classes for WELLBUTRIN SR
US Patents and Regulatory Information for WELLBUTRIN SR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||||
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 | 020358-002 | Oct 4, 1996 | AB1 | RX | 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 SR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-001 | Oct 4, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-001 | Oct 4, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-004 | Jun 14, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for WELLBUTRIN SR
See the table below for patents covering WELLBUTRIN SR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2189804 | ⤷ Try a Trial | |
European Patent Office | 0467488 | Composition à libération contrÔlée d'une substance active. (Composition for the controlled discharge of an active ingredient.) | ⤷ Try a Trial |
Japan | H06206817 | MEDICINAL COMPOSITION | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for WELLBUTRIN SR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2316456 | 1790064-8 | Sweden | ⤷ 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; REG. NO/DATE: EU/1/14/988 20150330 |
0656775 | 28/2000 | Austria | ⤷ Try a Trial | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
2316456 | C201730057 | Spain | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |