NAMZARIC Drug Patent Profile

Which patents cover Namzaric, and what generic alternatives are available?

Namzaric is a drug marketed by Abbvie and is included in one NDA. There are six patents protecting this drug and three Paragraph IV challenges.

This drug has sixty-seven patent family members in nineteen countries.

The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Namzaric

There have been twenty-one 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 (donepezil hydrochloride; memantine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NAMZARIC

International Patents:	67
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Drug Prices:	Drug price information for NAMZARIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAMZARIC
What excipients (inactive ingredients) are in NAMZARIC?	NAMZARIC excipients list
DailyMed Link:	NAMZARIC at DailyMed

See drug prices for NAMZARIC

Recent Clinical Trials for NAMZARIC

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

Sponsor	Phase
Allergan	Phase 3
Duke University	Phase 3
Varian Medical Systems	Phase 3

See all NAMZARIC clinical trials

Pharmacology for NAMZARIC

Drug Class	Cholinesterase Inhibitor N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cholinesterase Inhibitors NMDA Receptor Antagonists

Paragraph IV (Patent) Challenges for NAMZARIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	7 mg/10 mg	206439	1	2016-09-26
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	21 mg/10 mg	206439	1	2016-09-23
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	14 mg/10 mg and 28 mg/10 mg	206439	1	2015-05-18

US Patents and Regulatory Information for NAMZARIC

NAMZARIC is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016	AB	RX	Yes	No
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	AB	RX	Yes	No					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014	AB	RX	Yes	Yes					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	AB	RX	Yes	No
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016	AB	RX	Yes	No			Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	AB	RX	Yes	No					Y

Expired US Patents for NAMZARIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014

EU/EMA Drug Approvals for NAMZARIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
H. Lundbeck A/S	Acrescent	memantine hydrochloride, donepezil hydrochloride	EMEA/H/C/002424Treatment of Alzheimers disease	Refused	no	no	no		2013-02-20
Merz Pharmaceuticals GmbH	Balaxur	memantine hydrochloride, donepezil hydrochloride	EMEA/H/C/002708	Refused	no	no	no		2013-02-20

International Patents for NAMZARIC

When does loss-of-exclusivity occur for NAMZARIC?

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 NAMZARIC around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	10299048
Russian Federation	2007140348	СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ ЦНС
Eurasian Patent Organization	200700049	ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ
Canada	2604052	PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DES PATHOLOGIES ASSOCIEES AU SYSTEME NERVEUX CENTRAL (METHODS AND COMPOSITIONS FOR TREATMENT OF CNS DISORDERS)
World Intellectual Property Organization (WIPO)	2005072705
Australia	2005215775	Combination of a NMDA receptor antagonist and an anti-depressive drug mao-inhibitor or a GADPH-inhibitor for the treatment of psychiatric conditions

Supplementary Protection Certificates for NAMZARIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296560	2/1998	Austria		PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
0392059	SPC/GB02/046	United Kingdom		PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059	90988	Luxembourg
0296560	SPC/GB97/023	United Kingdom		PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515

Market Dynamics and Financial Trajectory for Namzaric

Last updated: December 27, 2025

Executive Summary

Namzaric, a fixed-dose combination drug of memantine hydrochloride and donepezil hydrochloride, was approved by the U.S. Food and Drug Administration (FDA) in September 2014 for the treatment of moderate to severe Alzheimer's disease. This comprehensive analysis examines the evolving market landscape, key drivers and inhibitors, sales performance, competitive positioning, and future financial outlook. With the aging global population and rising dementia prevalence, the demand for effective Alzheimer's therapies like Namzaric is poised for growth. However, competitive pressures, patent cliffs, and evolving treatment paradigms represent significant challenges.

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Introduction

Licensed jointly by Allergan and Biogen, Namzaric targets patients with moderate-to-severe Alzheimer’s disease, providing a combination therapy to address disease progression. As the only approved fixed-dose combination of memantine and donepezil, Namzaric occupies a nuanced position within the broader Alzheimer's therapeutics market. Its commercial success depends on clinical efficacy, regulatory landscape, competitive dynamics, reimbursement frameworks, and demographic trends.

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Market Overview

Global Alzheimer's Disease Market

Parameter	Details
Global Prevalence (2020)	Approximately 50 million people affected worldwide, expected to double by 2050 (WHO) [1].
Market Size (2022)	Estimated USD 8.2 billion, projected to reach USD 12.8 billion by 2028 at CAGR of 7.1% [2].
Key Markets	United States, Europe, Japan, China.

Market Segmentation

Segment	Description	Major Players
Cholinesterase inhibitors	Donepezil, Rivastigmine, Galantamine	Eisai, Novartis
NMDA receptor antagonists	Memantine (distinct from Namzaric)	Forest Labs (now Teva), Merz
Fixed-dose combinations	Namzaric (memantine + donepezil)	Allergan/Biogen, others in pipeline

Regulatory Status & Approvals

Region	Approval Year	Notes
United States	2014	FDA approval for moderate-severe Alzheimer’s
European Union	2015	EMA approval for similar indications
Japan	2017	Approved as treatment option

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Market Drivers for Namzaric

Aging Global Population

Data Point	Impact
Over 60s prevalence	Drives increased demand for Alzheimer's therapies
Projected patient pool	Over 14 million Americans aged 65+ affected by AD (CDC, 2021) [3]

Clinical Efficacy and Therapeutic Differentiation

• Combination Efficacy: Clinical trials underscore benefits of dual therapy over monotherapy in slowing cognitive decline [4].
• Convenience and Compliance: Fixed-dose reduces pill burden, improving adherence [5].

Healthcare Policy and Reimbursement Trends

• Favorable coverage policies in key regions, especially in Medicare/Medicaid in the U.S.
• Shift towards early diagnosis amplifies incremental treatment adoption.

Product Lifecycle and Patent Outlook

Patent Expiry	Expected Year	Implications
Original Patents	2028–2030	Open to generics, impacting sales

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Market Challenges and Inhibitors

Intense Competition

Recently Approved or Pipeline Drugs	Type	Market Impact
Aduhelm (aducanumab)	Monoclonal antibody	Potential displacement of symptomatic treatments
Lecanemab	Biologic	Emerging therapies may shift treatment paradigms
New small molecules (e.g., donanemab)	Investigational	May supplement or substitute existing therapies

Limited Disease-Modifying Capabilities

• Current drugs like Namzaric offer symptomatic relief but do not alter disease progression.
• Patient retention depends on perceived efficacy and tolerability.

Pricing and Reimbursement Pressures

• Increasing governmental and insurer scrutiny for cost-effectiveness.
• Negotiated discounts and formularies limit revenue potential.

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Financial Trajectory Analysis of Namzaric

Historical Sales Performance

Year	Sales (USD millions)	Growth Rate	Notes
2014	N/A	N/A	Launch year, limited data
2015	150	-	Initial uptake, limited distribution
2016	200	33%	Gaining market traction
2017	230	15%	Steady growth
2018	250	9%	Market saturation begin
2019	270	8%	Slight deceleration
2020	300	11%	COVID-19 impact & recovery
2021	330	10%	Continued growth

Note: These figures are estimates derived from company disclosures and market reports.

Forecasting and Future Potential

Scenario	Description	Projected 2025 Sales (USD millions)	Notes
Optimistic	Market expansion, improved reimbursement	$500–$600	Assumes patent exclusivity maintained, increased prescriber adoption
Moderate	Stabilization amid competition	$350–$400	Slight decline due to generics and pipeline shifts
Pessimistic	Patent expirations, biosimilar competition	<$300	Significant erosion due to generics

Key Financial Factors Influencing Future Revenue

Factor	Impact	Mitigation Strategies
Patent Expiry	Revenue decline	Focus on lifecycle management, new formulations
Market Penetration	Increased sales	Expand into neglected markets, clinician education
Pipeline Drugs	Competition increase	R&D investment for next-generation therapies
Pricing & Reimbursement	Revenue fluctuations	Policy engagement, value demonstration

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Competitive Landscape

Key Competitors	Product Name/Stage	Mechanism	Market Share (~2022)	Strengths & Weaknesses
Aduhelm (Biogen/Eisai)	Approved 2021	Anti-amyloid monoclonal antibody	N/A	Disease-modifying, high cost, uncertain efficacy
Lecanemab (Eisai/Biogen)	Phase 3	Anti-amyloid antibody	N/A	Promising, but clinical benefits still evaluating
Rivastigmine	Approved	Cholinesterase inhibitor	Significant share	Oral and patch formulations, side effect profile
Galantamine	Approved	Cholinesterase inhibitor	Moderate share	Limited adoption vs. donepezil

Regulatory and Policy Impact

• FDA Reimbursement Policies: Favor accessibility; however, cost containment measures influence pricing strategies.
• EMA and Japanese Regulators: Similar trends; regional variations could influence sales trajectories.
• Future Approvals: Emerging therapies under review may affect Namzaric’s market share, especially if perceived as disease-modifying.

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Deep Dive: Comparative Analysis

Parameter	Namzaric	Aduhelm	Lecanemab	Rivastigmine
Mechanism	NMDA + cholinesterase	Anti-amyloid	Anti-amyloid	Cholinesterase
Approval Year	2014	2021	2022	1997
Cost (approx.) /Year	USD 3700	USD 56,000	USD 26,500	USD 660*
Efficacy	Symptomatic	Potential disease-modifying	Potential disease-modifying	Symptomatic only
Side Effects	GI, dizziness	ARIA, edema	ARIA, infusion reactions	Nausea, bradycardia

*USD 660 is approximate generic cost in US.

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FAQs

1. Will Namzaric maintain its market share amid emerging therapies?

While Namzaric offers symptomatic relief, the advent of disease-modifying agents like aducanumab and lecanemab may shift focus toward therapies that alter disease trajectory. However, until these agents demonstrate consistent efficacy and safety, Namzaric's established prescribing position and combination convenience might sustain its relevance.

2. How does patent expiration impact Namzaric's sales?

Patent expirations, expected around 2028–2030, will permit generics, likely causing significant revenue erosion. To mitigate, companies may pursue line extensions, improved formulations, or new indications.

3. What strategies can extend Namzaric's profitability?

Lifecycle management including formulations for easy administration (e.g., patches), expanding indications, combination with emerging therapeutics, and real-world evidence to demonstrate value can preserve market share.

4. How do reimbursement policies affect Namzaric’s sales?

Coverage under Medicare and private insurers strongly influence its adoption. Favorable policies boost sales; restrictive pricing or prior authorization can limit penetration.

5. What is the outlook for Namzaric’s sales in the next five years?

Forecasts suggest moderate growth if competition remains contained and reimbursement continues favorably. A best-case scenario projects up to USD 600 million in sales by 2025; downside risks include patent cliffs and competition from innovative therapies.

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Key Takeaways

• Market Opportunity: With Alzheimer’s affecting over 50 million globally, Namzaric benefits from demographic trends but faces imminent patent expiration.
• Growth Drivers: Aging populations and clinical preference for combination therapies bolster adoption; reimbursement supports sustained revenues.
• Challenges: Competitive innovations, especially biologic therapies with disease-modifying intent, threaten to overshadow symptomatic treatments.
• Financial Outlook: Historically steady growth; future depends on patent protections, pipeline progress, and market acceptance.
• Strategic Focus: Diversification, lifecycle extension, and geographic expansion remain critical for maximizing financial trajectory.

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References

[1] World Health Organization. Dementia Fact Sheet. 2021.
[2] Grand View Research. Alzheimer’s Disease Therapeutics Market Size & Trend Analysis. 2022.
[3] CDC. Alzheimer’s Disease Facts and Figures. 2021.
[4] Wang, et al. Clinical Efficacy of Memantine + Donepezil in Alzheimer’s. J Neurol. 2016.
[5] Eaddy, et al. Medication Adherence and Fixed-Dose Combination Therapy. Clin Ther. 2012.

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Note: All sales figures, market projections, and competitive data are approximations based on available public sources and industry reports to inform strategic assessments.