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-six 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.
Summary for FORFIVO XL
International Patents: | 1 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 138 |
Patent Applications: | 1,189 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
Anatomical Therapeutic Chemical (ATC) Classes for FORFIVO XL
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORFIVO XL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2316456 | C201730057 | Spain | ⤷ Sign Up | 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 | 65/2017 | Austria | ⤷ Sign Up | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330 |
2316456 | 349 22-2017 | Slovakia | ⤷ Sign Up | 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 |
0656775 | 28/2000 | Austria | ⤷ Sign Up | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |