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FORFIVO XL Drug Profile

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Which patents cover Forfivo Xl, 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. Seventy-six suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for FORFIVO XL

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	4
Bulk Api Vendors:	103
Patent Applications:	888
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

Recent Litigation for FORFIVO XL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
INTELGENX CORP. v. WOCKHARDT BIO, AG	2013-08-23

See all FORFIVO XL litigation

Pharmacology for FORFIVO XL

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Synonyms for FORFIVO XL

( inverted question mark)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride

(.+-.)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride

(+-)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride

(+-)-alpha-tert-Butylamino-3-chloropropiophenone hydrochloride

(+/-)-1-(3-Chlorophenyl)-2- [(1,1-dimethylethyl)amino]- 1-propanone hydrochloride

(+/-)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride

(+/-)-2-(t-butylamino)-3'-chloropropiophenone hydrochloride

1-(3-CHLOROPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-1-PROPANONE HYDROCHLORIDE

1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, hydrochloride, (+-)-

1-Propanone,1-dimethylethyl)amino]-, hydrochloride, (.+-.)-

2-(tert-Butylamino)-1-(3-chlorophenyl)-1-propanone Hydrochloride

2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one HCl

2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one hydrochloride

2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one;hydrochloride

2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride

31677-93-7

34841-36-6

4CH-007122

77B937

A820950

AB0012179

AB02273

AB2000567

AC-196

AC1L1XZA

ACM34841366

AK-75760

AKOS015844544

alpha-(tert-Butylamino)-m-chloropropiophenone hydrochloride

AM20060780

Amfebutamon hydrochlorid

Amfebutamon hydrochloride

Amfebutamone (Bupropion)

Amfebutamone (Bupropion) HCl

AMFEBUTAMONE HCl

Amfebutamone hydrochloride

Amfebutamone(Bupropion)

AN-16061

ANW-42367

API0001440

AX8118984

B3649

BC208314

BCP0726000049

BCP22394

BCP9000462

BG0117

Budeprion

Budeprion XL

Budeprion XL 300

Bupropion (hydrochloride)

Bupropion Hcl

Bupropion hydrochloride

Bupropion hydrochloride (JAN/USP)

Bupropion hydrochloride [USAN:USP:JAN]

Bupropion hydrochloride [USAN:USP]

Bupropion Hydrochloride 1.0 mg/ml in Methanol (as free base)

Bupropion hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material

Bupropion hydrochloride, >=98% (HPLC), solid

Bupropion Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

Bupropion hydrochloride, United States Pharmacopeia (USP) Reference Standard

Bupropion hydrocloride

Bupropion SR

BW 322U; BVF 033; Amfebutamone

BW 323

BW-323

BW-323U66

CAS-31677-93-7

CCG-100911

CCG-39085

CHEBI:3220

CHEMBL1698

CPD000058423

CPI-300

CS-2503

CTK8B3357

D00817

DSSTox_CID_24561

DSSTox_GSID_44561

DSSTox_RID_80314

DTXSID6044561

EINECS 250-759-9

EINECS 252-243-9

Elontril

EU-0100166

FT-0081218

FT-0623288

HEYVINCGKDONRU-UHFFFAOYSA-N

HMS1568B20

HMS1922F09

HSDB 6988

HY-B0403A

I06-0019

I06-19

J10311

Jsp005899

KB-224632

KS-00000XL2

KS-1034

LP00166

LS-125089

M-5146

m-Chloro-alpha-tert-butylaminopropionphenone hydrochloride

m-Chloro-alpha-tert-butylaminopropiophenone hydrochloride

MFCD00055209

MLS000069376

MLS001401370

MLS002320678

NC00161

NCGC00015122-11

NCGC00016807-01

NCGC00093650-01

NCGC00093650-02

NCGC00093650-03

NCGC00093650-04

NCGC00093650-05

NCGC00180895-01

NCGC00180895-02

NCGC00255927-01

NCGC00260851-01

NSC 315851

NSC-315851

NSC-758686

NSC315851

NSC758686

Pharmakon1600-01504174

Prestwick_668

Propiophenone, 2-(tert-butylamino)-3'-chloro-, hydrochloride, (+-)-

Propiophenone, hydrochloride, (.+-.)-

PubChem20752

Quomem

S2452

SAM001246723

SC-12179

SCHEMBL41602

SMR000058423

SMR001338824

SPECTRUM1504174

SR-01000002989

SR-01000002989-10

SR-01000002989-2

ST24027672

SW196823-6

TC-010273

Tox21_110621

Tox21_110621_1

Tox21_301844

Tox21_500166

V2047

Voxra

Wellbutrin

Wellbutrin (TN)

Wellbutrin Retard

Wellbutrin SR

Wellbutrin XL

Wellbutrin XR

Wellbutrin;Zyban;Voxra;Budeprion;Aplenzin;Bupropion

Zyban

Zyban (pharmaceutical)

Zyban (TN)

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			Y

International Patents for FORFIVO XL

Country	Patent Number	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	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	65/2017	Austria		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	1790064-8	Sweden		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; REG. NO/DATE: EU/1/14/988 20150330