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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.
Summary for FORFIVO XL
| International Patents: | 1 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 104 |
| Patent Applications: | 916 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FORFIVO XL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FORFIVO XL |
| DailyMed Link: | FORFIVO XL at DailyMed |
Pharmacology for FORFIVO XL
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
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 |
International Patents for FORFIVO XL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2008038155 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
