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Last Updated: March 18, 2024

FORFIVO XL Drug Patent Profile


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

Forfivo Xl is a drug marketed by Twi Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in FORFIVO XL 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 Forfivo Xl

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

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Paragraph IV (Patent) Challenges for FORFIVO XL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FORFIVO XL Extended-release Tablets bupropion hydrochloride 450 mg 022497 1 2013-02-28

US Patents and Regulatory Information for FORFIVO XL

FORFIVO XL is protected by one US patents.

Patents protecting FORFIVO XL

Sustained-release bupropion and bupropion/mecamylamine tablets
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Twi Pharms FORFIVO XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497-001 Nov 10, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for FORFIVO XL

See the table below for patents covering FORFIVO XL around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2008038155 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FORFIVO XL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 349 22-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
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
2316456 17C1058 France ⤷  Try a Trial 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
0656775 28/2000 Austria ⤷  Try a Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
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 SPC/GB17/078 United Kingdom ⤷  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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2316456 2017C/064 Belgium ⤷  Try a Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND 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.