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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-seven 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:	2
Bulk Api Vendors:	95
Patent Applications:	814
Formulation / Manufacturing:	see details
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

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-PROPANE, MONOHYDROCHLORIDE

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) HCl

Amfebutamone hydrochloride

Amfebutamone(Bupropion)

AN-16061

ANW-42367

API0001440

AX8118984

B3649

BC208314

BCP0726000049

BCP9000462

BG0117

Bio-0883

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; traceable to USP

Bupropion hydrochloride, United States Pharmacopeia (USP) Reference Standard

Bupropion hydrocloride

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

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

OR147496

Pharmakon1600-01504174

Prestwick_668

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

Propiophenone, hydrochloride, (.+-.)-

PubChem20752

Quomem

S2452

SAM001246723

SC-12179

SCHEMBL41602

SMR000058423

SMR001338824

SPECTRUM1504174

ST24027672

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)

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

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Paragraph IV (Patent) Challenges for FORFIVO XL

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Tablets	450 mg		2013-02-28

Non-Orange Book US Patents for FORFIVO XL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,703,191	Controlled-release pharmaceutical tablets

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International Patents for FORFIVO XL

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for FORFIVO XL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017000109	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
0918	Netherlands		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
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
2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201