APLENZIN Drug Patent Profile

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

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

This drug has fifty-two patent family members in eighteen 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.

DrugPatentWatch^® Generic Entry Outlook for Aplenzin

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2022 were $25mm indicating the motivation for generic entry (peak sales were $395mm in 2013).

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (bupropion hydrobromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for APLENZIN

International Patents:	52
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	177
Drug Prices:	Drug price information for APLENZIN
Drug Sales Revenues:	Drug sales revenues for APLENZIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APLENZIN
What excipients (inactive ingredients) are in APLENZIN?	APLENZIN excipients list
DailyMed Link:	APLENZIN at DailyMed

See drug prices for APLENZIN

See drug sales revenues for APLENZIN

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for APLENZIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4
SRI International	Phase 4

See all APLENZIN clinical trials

Pharmacology for APLENZIN

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

Paragraph IV (Patent) Challenges for APLENZIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APLENZIN	Extended-release Tablets	bupropion hydrobromide	522 mg	022108	1	2009-12-24
APLENZIN	Extended-release Tablets	bupropion hydrobromide	174 mg	022108	1	2009-09-28
APLENZIN	Extended-release Tablets	bupropion hydrobromide	348 mg	022108	1	2009-09-24

US Patents and Regulatory Information for APLENZIN

APLENZIN is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

International Patents for APLENZIN

When does loss-of-exclusivity occur for APLENZIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering APLENZIN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2006261788	Modified-release formulations of a bupropion salt
Australia	2008285660	Bupropion hydrobromide and therapeutic applications
Australia	2008320915	Bupropion hydrobromide and therapeutic applications
Canada	2578626	FORMULATIONS A LIBERATION MODIFIEE D'UN SEL DE BUPROPION (MODIFIED-RELEASE FORMULATIONS OF A BUPROPION SALT)

Supplementary Protection Certificates for APLENZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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	CR 2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201

DrugChatter Q&A for APLENZIN

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