APLENZIN Drug Patent Profile

Which patents cover Aplenzin, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APLENZIN

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.

This potential generic entry date is based on patent 7,241,805.

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	7,569,610
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	7,572,935		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	7,585,897		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	7,649,019		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	7,585,897		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No	7,585,897		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	7,671,094		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
Russian Federation	2485943	БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF)
New Zealand	582925	Use of bubropion hydrobromide for the prevention of seizures associated with bupropion administration
South Africa	200711123	Modified-release formulations of a bupropion salt
China	101534808
Australia	2008320915	Bupropion hydrobromide and therapeutic applications
Costa Rica	9609
Canada	2655596	SYSTEME DE DELIVRANCE OSMOTIQUE MULTIPARTICULAIRE (MULTIPARTICULATE OSMOTIC DELIVERY SYSTEM)

Supplementary Protection Certificates for APLENZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	2017/059	Ireland		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; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
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
2316456	SPC/GB17/078	United Kingdom		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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
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

Investment Scenario and Fundamentals Analysis for APLENZIN (Nuvigil)

Last updated: February 20, 2026

What Is APLENZIN?

APLENZIN is the brand name for a combination of phentermine and topiramate. It is marketed as a weight management medication aimed primarily at obese or overweight adults with comorbidities. The drug was approved by the FDA in 2012 under the brand name Qsymia and marketed by Vivus Inc. It is not a standalone treatment but a combination drug targeting both appetite suppression and weight loss enhancement.

Market Overview and Commercial Positioning

Industry Context

The global weight management drug market was valued at approximately $3 billion in 2021. It is expected to grow at a compound annual growth rate (CAGR) of about 8% through 2030 [1]. The increase hinges on rising obesity prevalence in developed and emerging markets, coupled with the failure of lifestyle interventions alone.

Competitive Landscape

Competitors include:

• Semaglutide (Wegovy): Marketed by Novo Nordisk, approved in 2021, with sales reaching $1.2 billion in 2022.
• Orlistat (Xenical, Alli): Over-the-counter and prescription options, established market presence.
• Contrave (naltrexone/bupropion): Approved since 2014, limited efficacy compared to newer drugs.
• Qsymia (phentermine and topiramate): A direct predecessor, marketed by Vivus Inc.

APLENZIN (Qsymia) holds a marginal market share because of safety concerns, partly due to the teratogenic risk associated with topiramate.

Revenue and Sales Data

Vivus Inc. reports revenue fluctuations driven by prescription patterns:

Year	Approximate Sales (USD millions)	Comments
2020	$60	Stable, pending generic challenges
2021	$72	Slight increase, market stabilization
2022	$75	Marginal growth due to increased awareness

Pharmacological and Regulatory Fundamentals

Mechanism of Action

• Phentermine: Sympathomimetic that suppresses appetite.
• Topiramate: Originally an anticonvulsant, promotes weight loss via appetite suppression and increased satiety.

FDA Status and Labeling

• Approval: 2012 under Qsymia brand.
• Indications: Chronic weight management in adults with BMI ≥30, or ≥27 with comorbidities.
• Safety Concerns:
  • Teratogenic risk: Women are advised to use contraception during treatment.
  • Cognitive effects, mood changes, and metabolic disturbances reported.

Patent and Exclusivity Status

• Original patent expired in 2021.
• Current formulations can face generics entry which may impact revenue.

Investment Considerations

Market Growth Potential

The increasing obesity rate globally suggests steady demand. The segment's growth depends on increasing acceptance, reimbursement policies, and approval of next-generation combinations.

R&D and Pipeline

Vivus Inc. and other producers are exploring new formulations, extended-release versions, and adjunct therapies, although no recent registration trials for APLENZIN-specific enhancements have been announced.

Regulatory and Safety Risks

Post-market safety issues and the potential need for black box warnings could hinder market expansion. The teratogenic risk limits its appeal for certain demographics.

Competitive Advantages and Barriers

• Established safety profile, albeit with reservations.
• Limited differentiation from newer agents with better safety profiles.
• Patent expiry opening avenues for generics, putting pressure on pricing.

Financial Outlook

Vivus Inc. has faced financial challenges due to sales stagnation and patent expiry. The company reports operating losses, with revenues primarily coming from existing sales and licensing agreements.

Investment Risks and Opportunities

Risks	Opportunities
Patent expiry leads to generic competition	Market expansion driven by rising obesity prevalence
Safety concerns limit prescription	Development of next-generation formulations
Competition from newer drugs with better safety profiles	Potential for partner licensing agreements

Key Data Summary

Aspect	Details
Market Size (2021)	$3 billion globally
CAGR (2022–2030)	8%
Major Competitors	Wegovy, Xenical, Contrave
Revenue Trend (2020–2022)	Marginal growth from $60M to $75M
Patent Status	Expired 2021
Approved Indications	BMI ≥30 or ≥27 with comorbidities

Key Takeaways

• APLENZIN/RQysmia remains a niche product, with sales plateauing post-patent expiry.
• Growth prospects depend on the successful launch of new formulations or combination therapies.
• Safety concerns act as barriers to broader adoption.
• Competition from newer agents favors the latter’s market share, especially those with better safety profiles.
• The absence of recent pipeline breakthroughs limits near-term outlooks.

FAQs

1. What are the main drivers for APLENZIN's market performance?
Obesity prevalence, safety profile, patent status, and the response to safety concerns influence sales.

2. How does APLENZIN's efficacy compare to newer weight management drugs?
It demonstrates moderate efficacy but is often overshadowed by drugs like semaglutide with superior weight loss results.

3. What are regulatory risks affecting APLENZIN?
Black box warnings for teratogenic effects and adverse cognitive effects can restrict use and impact sales.

4. How significant is patent expiry for potential generic competition?
Patent expiry in 2021 opens the market to generics, pressuring price and margins.

5. What are potential growth avenues for APLENZIN?
Reformulations, combination with other agents, and expanding indications could provide growth, contingent on safety and efficacy improvements.

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[1] MarketResearch.com. (2022). Global Obesity and Weight Management Drug Market Forecast.