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Last Updated: June 2, 2024

ZYBAN Drug Patent Profile


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When do Zyban patents expire, and what generic alternatives are available?

Zyban is a drug marketed by Glaxosmithkline and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Zyban

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

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US Patents and Regulatory Information for ZYBAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 DISCN 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 ZYBAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZYBAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 1790064-8 Sweden ⤷  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; REG. NO/DATE: EU/1/14/988 20150330
2316456 C201730057 Spain ⤷  Sign Up 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 132017000142109 Italy ⤷  Sign Up PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
0656775 CR 2000 00018 Denmark ⤷  Sign Up PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
>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.