FORFIVO XL Drug Patent Profile

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

Forfivo Xl is a drug marketed by Almatica 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-five 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 7^th, 2000.

Summary for FORFIVO XL

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	1,179
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

See drug prices for FORFIVO XL

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

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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

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

Supplementary Protection Certificates for FORFIVO XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	CA 2017 00062	Denmark		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
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	17C1058	France		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	C201730057	Spain		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	122017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326