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-seven 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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Summary for ZYBAN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 205 |
| Patent Applications: | 4,371 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZYBAN |
| DailyMed Link: | ZYBAN at DailyMed |
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 | 020711-003 | 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 | 020711-002 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-003 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZYBAN
See the table below for patents covering ZYBAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | 223528 | Bupropiont tartalmazó, stabilizált gyógyászati készítmény (STABILIZED PHARMACEUTICAL COMPOSITION CONTAINING BUPROPION) | ⤷ Sign Up |
| Japan | H075457 | ⤷ Sign Up | |
| Hungary | 9501879 | ⤷ Sign Up | |
| Malaysia | 128088 | STABILIZED PHARMACEUTICAL COMPOSITION CONTAINING BUPROPION | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZYBAN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 17C1058 | France | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| 2316456 | 2017/059 | Ireland | ⤷ 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; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| 0656775 | CR 2000 00018 | Denmark | ⤷ Sign Up | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
| 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 |
| >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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