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: ⤷ 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 | 65/2017 | Austria | ⤷ Try a Trial | 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 | CR 2017 00062 | Denmark | ⤷ Try a 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 | 300918 | Netherlands | ⤷ Try a Trial | 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 |
2316456 | 2017/059 | Ireland | ⤷ 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; REGISTRATION NO/DATE: EU/1/14/988 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |