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Last Updated: June 14, 2021

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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-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

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   Get Started Free   Get Started Free Y   Get Started Free
>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 C201730057 Spain   Get Started Free 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
0656775 CR 2000 00018 Denmark   Get Started Free PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2316456 300918 Netherlands   Get Started Free 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
>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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