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APLENZIN Drug Profile

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

Aplenzin is a drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-one patent family members in seventeen countries.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrobromide profile page.

Summary for APLENZIN

International Patents:	51
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	8
Clinical Trials:	1
Patent Applications:	47
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for APLENZIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APLENZIN
DailyMed Link:	APLENZIN at DailyMed

Generic Entry Opportunity Date for APLENZIN

NDA:

022108

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for APLENZIN

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

Synonyms for APLENZIN

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

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

( -)-2-(tert-Butylamino)-3'-chlorpropiophenon

(-)-2-(tert-butylamino)-3'-chloropropiophenone

(-)-2-(tert-Butylamino)-3'-chlorpropiophenon

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

(.+/-.)-Bupropion

(+-)-1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone

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

(+-)-2-(tert-Butylamino)-3'-chlorpropiophenon

(+-)-Bupropion

(+/-)-bupropion

1-(3-Chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone

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

1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]propan-1-one

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

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

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

1-Propanone, 1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl)amino]-

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

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

2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide

2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide

2-(Tert-Butylamino)-3'-chloropropiophenone

2-tert-Butylamino-1-(3-chlorophenyl)propan-1-one

3'-Chloro-alpha-(tert-butylamino)propiophenone

34841-39-9

34911-55-2

8068AH

905818-69-1

AB00053756

AB00053756_20

AB00053756_21

AB00053756-16

AB00053756-18

AB00053756-19

AC-197

AC1L198Y

ACM34841399

ACM34911552

AK-34646

AK-75761

AKOS015917698

AKOS015961770

alpha-(tert-butylamino)-m-chloropropiophenone

AM807634

Amfebutamon

Amfebutamona

Amfebutamona [INN-Spanish]

Amfebutamone

AMFEBUTAMONE HCl

amfebutamonum

Amfebutamonum [INN-Latin]

AN-16060

API0008795

Aplenzin ER

AX8020179

BBL029065

BC219839

BDBM50048392

BPBio1_000042

BRD-A05186015-003-05-7

BRN 2101062

BSPBio_000038

BSPBio_002247

Budeprion (Salt/Mix)

bupropion

bupropion (amfebutamone)

Bupropion (INN)

Bupropion (Old RN)

Bupropion (USAN)

Bupropion [INN:BAN]

bupropion HBr

Bupropion hydrobromide

Bupropion hydrobromide (USAN)

Bupropion hydrobromide [USAN]

Bupropion hydrocloride

Bupropion SR

Bupropion+naltrexone

bupropionhydrochloride

BW-323

C-6222

C06860

CCG-100858

CCG-204261

CHEBI:3219

CHEMBL1201735

CHEMBL894

Contrave (TN)

CPD000472526

D01TMQ

D07591

D07938

D0X4ZR

DB01156

DivK1c_007050

DR000564

DTXSID7022706

Elont

Elontril

FT-0630586

GTPL7135

HMS2051G10

HMS2089G14

HMS2232P04

HMS3369P11

HMS3393G10

HSDB 6988

I14-9201

Jsp006301

KB-213778

KBio1_001994

KBio2_002143

KBio2_004711

KBio2_007279

KBio3_001467

KBioGR_001168

KBioSS_002143

L000725

Lopac0_000166

LS-122817

MLS001424015

MRF-0000143

NC00108

NCGC00015122-03

NCGC00015122-04

NCGC00015122-06

NCGC00015122-07

NCGC00015122-09

NCGC00089751-02

NCI60_002714

NSC315851

OR261068

Prestwick0_000249

Prestwick1_000249

Prestwick2_000249

Prestwick3_000249

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

SAM001246699

SBI-0050154.P003

SCHEMBL38777

SCHEMBL636116

SMR000472526

SNPPWIUOZRMYNY-UHFFFAOYSA-N

SPBio_001817

SPBio_002257

SpecPlus_000954

Spectrum_001663

Spectrum2_001659

Spectrum3_000644

Spectrum4_000614

Spectrum5_001406

STL373006

TL8002604

Wellbatrin

Wellbutrin (Salt/Mix)

Wellbutrin, Zyban

WSTCENNATOVXKQ-UHFFFAOYSA-N

Zyban

Zyban (Salt/Mix)

US Patents and Regulatory Information for APLENZIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y

Paragraph IV (Patent) Challenges for APLENZIN

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	522 mg
	Extended-release Tablets	348 mg
	Extended-release Tablets	174 mg

International Patents for APLENZIN

Country	Document Number	Estimated Expiration
China	101903016
Ecuador	SP109923
Canada	2655596
New Zealand	561375
Japan	2010535740
Costa Rica	9609

Supplementary Protection Certificates for APLENZIN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
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
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
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
C/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607