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Last Updated: August 11, 2020

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FORFIVO XL Drug Profile

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

Forfivo Xl is a drug marketed by Alvogen 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. Sixty-eight suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

US ANDA 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.

  Start Trial

Paragraph IV (Patent) Challenges for FORFIVO XL
Tradename Dosage Ingredient NDA Submissiondate
FORFIVO XL TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 022497 2013-02-28

US Patents and Regulatory Information for FORFIVO XL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen FORFIVO XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497-001 Nov 10, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for FORFIVO XL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 17C1058 France   Start 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
2316456 CR 2017 00062 Denmark   Start Trial 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 C 2017 047 Romania   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Express Scripts
Colorcon
Dow
AstraZeneca

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