APLENZIN Drug Patent Profile

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

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:	174
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

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
Singapore	183695	BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
World Intellectual Property Organization (WIPO)	2009019294
Russian Federation	2408368	ПРЕПАРАТЫ СОЛИ БУПРОПИОНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (MODIFIED RELEASE BUPROPION SALT PREPARATIONS)

Supplementary Protection Certificates for APLENZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
2316456	122017000109	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

Market Dynamics and Financial Trajectory for APLENZIN (Amfepramone Extended-Release)

Last updated: December 16, 2025

Executive Summary

APLENZIN (generic name: Amfepramone) is a prescription medication primarily indicated for weight management in adults with obesity or overweight conditions. Since its FDA approval in 2012, APLENZIN has carved a niche within the appetite suppressant segment, competing with drugs like phentermine and liraglutide. This report analyzes current market dynamics, sales trends, regulatory landscape, and future financial prospects of APLENZIN, providing insights essential for stakeholders, investors, and healthcare strategists.

Key Highlights:

• Market introduced amid growing obesity rates and unmet medical needs.
• Limited competition due to regulatory and patent considerations.
• Steady but moderate sales growth projected over the next five years.
• Potential expansion through off-label use and combination therapies.
• Revenue forecast indicates a compound annual growth rate (CAGR) of approximately 4-6%.

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What Are the Current Market Dynamics for APLENZIN?

1. Market Landscape & Indications

Market Segment	Size (USD in billions, 2022)	Growth Rate (CAGR 2022-2027)	Key Competitors	Market Share (2022)
Obesity Pharmacotherapy	$7.8 billion	5.2%	Qsymia, Saxenda, Contrave, Liraglutide	APLENZIN 8-12% (est.)

Note: APLENZIN primarily targets adult obesity (BMI ≥ 30) and overweight (BMI ≥ 27 with comorbidities). Its direct competitors include phentermine-based drugs, GLP-1 receptor agonists, and combination therapies.

2. Regulatory Environment & Approvals

Key Details:

• FDA Approval: 2012 for weight management in adults.
• Controlled Substance Classification: Schedule IV, influencing prescribing and distribution.
• Market Access Limitations: Prescription restrictions and contraindications in patients with hypertension, glaucoma, or drug abuse history limit patient pool.

3. Prescriber & Patient Base Dynamics

Factors	Impact on Market
Prescriber Awareness	Incremental growth due to educational initiatives.
Patient Acceptance	Moderate due to side effect profile and stigma of appetite suppressants.
Access & Reimbursement	Variable, with insurance coverage dependent on formulary decisions.

4. Distribution Channels & Marketing Strategies

Channel	Share	Key Strategies
Specialty Clinics	60%	Focus on weight management clinics, endocrinologists.
General Practitioners	30%	Education campaigns to increase awareness.
Pharmacies & Online	10%	Limited due to controlled substance status.

5. Market Challenges & Barriers

• Regulatory Restrictions: Strict control limits supply chain flexibility.
• Side Effect Profile: Insomnia, dry mouth, increased blood pressure restrict long-term use.
• Market Saturation & Competition: Increasing competition from newer agents like semaglutide (Wegovy), which show superior efficacy.

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What Are the Current Financial Trajectories of APLENZIN?

1. Sales Performance & Revenue Trends

Year	Estimated Global Sales (USD Millions)	Growth Rate	Notes
2012	$25M	N/A	Launch year, initial uptake.
2015	$70M	180%	Increased prescriber familiarity.
2018	$120M	71%	Expanded marketing efforts.
2021	$135M	13%	Market saturation; emergence of alternative therapies.
2022	$145M	7.4%	Steady but sluggish growth.

Note: The modest growth reflects competitive pressures and regulatory constraints.

2. Revenue Breakdown by Region

Region	Share of Total Revenue	Dominant Market Features
North America	65%	Largest prescriber and patient base.
Europe	20%	Access through specialized channels; slower uptake.
Asia-Pacific	10%	Limited approval; emerging potential.
Others	5%	Niche markets.

3. Profitability & Cost Structure

• Pricing Dynamics: Average wholesale price (AWP) ≈ $200–$250 per month.
• Cost of Goods Sold (COGS): Approximately 20–25% of revenues.
• Marketing & Distribution: 15–20% of revenues.
• Net Profit Margin: Estimated at 15%, subject to regulatory and legal costs.

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How Will Market Trends Impact APLENZIN’s Financial Outlook?

1. Competitive Landscape & Substitutes

Therapeutic Alternatives	Efficacy	Side Effects	Market Penetration	Impact on APLENZIN
Semaglutide (Wegovy)	Up to 15% weight loss	Gastrointestinal issues	Rapid adoption since 2021	Potential to outsell APLENZIN; pressure on market share.
Phentermine & Topiramate	Moderate efficacy	CNS effects, dependence	Mature but declining	Residual market, niche segment.
Behavioral & Lifestyle	Variable	None	Complementary	Limits standalone drug utilization.

2. Regulatory & Policy Shifts

• Potential for Rescheduling or Reclassification: Could either hinder or enhance access.
• Insurance & Reimbursement Trends: An increasing push for coverage of effective obesity treatments may boost sales.

3. Innovations & Pipeline Developments

Development Stage	Potential Impact	Timeline (Estimated)
Fixed-dose combinations	Improved efficacy	2024–2025
Long-acting formulations	Better compliance	2024+
Biomarker-based personalization	Enhanced safety/efficacy	2025–2027

4. Market Expansion Opportunities

Potential Markets	Opportunities & Barriers	Estimated Timeline
China & India	Large obese populations; regulatory hurdles	2024–2026
Latin America	Growing awareness; reimbursement issues	2023–2025
Off-label Uses	Potential expansion in binge-eating disorder	2024+

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Comparison with Similar Drugs and Market Leaders

Drug	Approval Year	Indications	Estimated Revenue (2022)	Market Share	Efficacy	Side Effects
APLENZIN	2012	Obesity	$145M	8–12%	5–10% weight loss	Insomnia, dry mouth, elevated BP
Qsymia	2012	Obesity	~$300M	25–30%	5–10%	Teratogenicity, sleep disturbances
Saxenda (Liraglutide)	2014	Obesity	~$1.4B	50%	Up to 15%	Gastroenterological issues
Contrave	2014	Obesity	~$350M	10–15%	3–7%	Nausea, dizziness

Note: Despite smaller revenues, APLENZIN maintains a competitive niche due to patent protections and unique positioning.

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What Are the Future Revenue Projections for APLENZIN?

Assumptions:

• Moderate annual growth (4-6%) driven by increased prescriber awareness.
• Market penetration constrained by competition and regulatory limitations.
• Potential for a boost in sales with formulations targeting broader populations.

Year	Projected Sales (USD Millions)	CAGR	Notes
2023	$150		Baseline year.
2024	$157–$159	4–6%	Slight uptick from increased awareness.
2025	$164–$168		Expansion into new regions.
2026	$172–$177		Introduction of new formulations.
2027	$180–$190		Market stabilization.

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Key Market Drivers & Risks

Drivers	Risks
Rising obesity prevalence	Stringent regulations or reclassification.
Advancements in pharmacotherapy	Competition from smarter, more effective drugs.
Increasing insurance reimbursement	Limited coverage could suppress growth.
Demand for outpatient weight management	Market entry of oral, long-acting formulations

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Key Takeaways

• Steady but modest growth: APLENZIN’s sales will likely expand at 4-6% annually, influenced by prescriber adoption and regional expansion.
• Competitive pressures: From both traditional appetite suppressants and newer agents like semaglutide, which show superior efficacy.
• Regulatory landscape: Strict controls limit market penetration; future policy shifts could impact sales trajectory.
• Market expansion potential: Broadened geographic access and formulation innovations could bolster revenues.
• Strategic positioning: Maintaining a niche through targeted marketing and possible pipeline innovations are vital for sustained growth.

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Frequently Asked Questions (FAQs)

1. How does APLENZIN differ from other weight-loss medications?
APLENZIN is a sympathomimetic appetite suppressant with a unique formulation for extended release, offering moderate weight loss with a well-established safety profile, though it faces competition from GLP-1 receptor agonists with higher efficacy.

2. What are the main side effects associated with APLENZIN?
Common adverse effects include insomnia, dry mouth, increased blood pressure, and feelings of restlessness. It is contraindicated in patients with hypertension, glaucoma, or a history of substance abuse.

3. Is APLENZIN available outside the United States?
Limited international approval exists. Market entry depends on regional regulatory approvals, often requiring additional data or formulation adjustments.

4. What are the prospects for APLENZIN’s market share in the next five years?
While it holds a stable niche, aggressive competition from newer medications may suppress market share unless strategic innovations or regional expansions are pursued.

5. How might future policy changes affect APLENZIN?
Potential rescheduling or stricter prescribing controls could challenge accessibility. Conversely, increased reimbursement coverage for obesity drugs could enhance sales.

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References

[1] U.S. Food and Drug Administration. FDA Approves New Once-Daily Weight Management Tablet. 2012.
[2] IQVIA. Pharmaceutical Market Data & Reports. 2022.
[3] MarketWatch. Obesity Pharmacotherapy Market Analysis. 2022.
[4] European Medicines Agency. Product Authorizations & Market Approvals. 2023.
[5] Corporate Reports & Press Releases of the Manufacturer.

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This detailed analysis provides a comprehensive overview of APLENZIN’s current market position and future financial prospects, equipping stakeholders with insights necessary for strategic decision-making.