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APLENZIN Drug Profile

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Which patents cover Aplenzin, and when can generic versions of Aplenzin launch?

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
Prior Art and Litigation Support	Order Prior Art and Litigation support 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

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

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

905818-69-1

AKOS015917698

Aplenzin (TN)

Aplenzin ER

bupropion HBr

Bupropion hydrobromide

Bupropion hydrobromide (USAN)

Bupropion hydrobromide [USAN]

CHEMBL1201735

D07938

I14-9201

SCHEMBL636116

WSTCENNATOVXKQ-UHFFFAOYSA-N

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

Paragraph IV (Patent) Challenges for APLENZIN

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

International Patents for APLENZIN

Country	Patent Number	Estimated Expiration
Canada	2655596
South Korea	20100055402
Mexico	2010001449
Russian Federation	2010116863
European Patent Office	2185139

Supplementary Protection Certificates for APLENZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	LUC00054	Luxembourg		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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	CR 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
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