WELLBUTRIN SR Drug Patent Profile
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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-seven 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.
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Summary for WELLBUTRIN SR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Clinical Trials: | 85 |
| Patent Applications: | 1,189 |
| 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 |
|---|---|
| Pfizer | Phase 1 |
| Mclean Hospital | Phase 4 |
| Kenya Medical Research Institute | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-004 | Jun 14, 2002 | AB1 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-002 | Oct 4, 1996 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-003 | Oct 4, 1996 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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
International Patents for WELLBUTRIN SR
See the table below for patents covering WELLBUTRIN SR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 3485618 | ⤷ Sign Up | |
| European Patent Office | 0656775 | COMPRIMES A LIBERATION PROLONGEE CONTENANT DU BUPROPIONE (SUSTAINED RELEASE TABLETS CONTAINING BUPROPION) | ⤷ Sign Up |
| Singapore | 43911 | Sustained release-tablets containing bupropion | ⤷ Sign Up |
| European Patent Office | 0711154 | COMPOSITION PHARMACEUTIQUE STABILISEE CONTENANT DU BUPROPION (STABILIZED PHARMACEUTICAL COMPOSITION CONTAINING BUPROPION) | ⤷ Sign Up |
| Israel | 106693 | CONTROLLED SUSTAINED RELEASE TABLETS CONTAINING BUPROPION HYDROCHLORIDE | ⤷ Sign Up |
| Spain | 2111168 | ⤷ Sign Up | |
| Germany | 69432121 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for WELLBUTRIN SR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | CR 2017 00062 | Denmark | ⤷ Sign Up | 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 | 2017C/064 | Belgium | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | 300918 | Netherlands | ⤷ Sign Up | 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 | LUC00054 | Luxembourg | ⤷ Sign Up | 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 |
| 0467488 | 2000C/021 | Belgium | ⤷ Sign Up | |
| 2316456 | SPC/GB17/078 | United Kingdom | ⤷ Sign Up | 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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
| 2316456 | CA 2017 00062 | Denmark | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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