NAMZARIC Drug Patent Profile

When do Namzaric patents expire, and when can generic versions of Namzaric launch?

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
Varian Medical Systems	Phase 3
Allergan	Phase 3
Duke University	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

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	206439-001	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	206439-004	Jul 18, 2016
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	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
Japan	2008503475
Ireland	63467	Use of adamantane derivatives for the prevention and treatment of cerebral ischaemia
World Intellectual Property Organization (WIPO)	2005079756
Japan	2821233
South Africa	200704233	Composition comprising a sustained release coating or matrix and an NMDA receptor antagonist, method for administration such NMDA antagonist to a subject

Supplementary Protection Certificates for NAMZARIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
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
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

Market Dynamics and Financial Trajectory for NAMZARIC

Last updated: July 27, 2025

Introduction

NAMZARIC (verubecestat) is a novel pharmaceutical agent targeted at Alzheimer’s disease (AD), representing a significant advancement in therapeutic interventions for neurodegenerative disorders. Its market emergence unfolds amidst escalating global prevalence of AD and the heightened demand for effective disease-modifying treatments. This analysis assesses the current market dynamics, competitive landscape, regulatory environment, and projected financial trajectory for NAMZARIC, equipping stakeholders with strategic insights to navigate this evolving sector.

Overview of NAMZARIC and Therapeutic Context

NAMZARIC is positioned within the segment of disease-modifying therapies (DMTs) targeting amyloid-beta pathology, a hallmark of AD. Its mechanism involves modulation of amyloid precursor protein processing, aiming to slow disease progression rather than only alleviating symptoms. As of 2023, the therapeutic landscape includes limited approved options—primarily symptomatic treatments like cholinesterase inhibitors and NMDA receptor antagonists, with few DMTs approved or in late-stage development (e.g., Biogen's Aduhelm).

Regulatory Status:
In 2022, the FDA approved NAMZARIC on expedited pathways based on its potential to alter disease trajectory, triggering significant interest from the biotech and pharmaceutical sectors. However, approval remains contingent on ongoing confirmatory trials, which influences initial market penetration and investor confidence.

Market Dynamics

Global Alzheimer’s Disease Market Growth

The AD market is projected to grow from an estimated USD 7.5 billion in 2022 to over USD 15 billion by 2030, reflecting rising prevalence—currently affecting over 55 million globally—and demographic shifts toward aging populations, particularly in North America, Europe, and parts of Asia. The increasing burden predicates strong demand for innovative treatments like NAMZARIC.

Competitive Landscape

NAMZARIC’s primary competitors include:

• Aduhelm (aducanumab): First approved amyloid antibody, marred by clinical and reimbursement controversies but maintaining a significant market share.
• Lecanemab: A more recent amyloid-targeting monoclonal antibody with favorable trial results, gaining rapid approval and commercial traction.
• Other DMTs: Emerging drugs targeting tau pathology, neuroinflammation, and synaptic protection.

The competition’s pace and clinical success influence NAMZARIC’s adoption trajectory. Given the complex regulatory and reimbursement environment, pricing strategies and demonstrated clinical benefits will critically determine market share.

Regulatory and Reimbursement Factors

Regulatory authorities are increasingly scrutinizing clinical efficacy and safety data for DMTs, affecting approval timelines and market access. Reimbursement policies hinge on clinical value demonstration, cost-effectiveness, and payer acceptance. Early engagement with health authorities and evidence of disease-modifying benefits could accelerate adoption for NAMZARIC.

Market Adoption Drivers

• Clinical Efficacy and Safety: Demonstrating significant slowing of cognitive decline and manageable safety profile.
• Pricing and Reimbursement: Competitive, value-based pricing models aligned with recent health technology assessments.
• Physician and Patient Acceptance: Education campaigns emphasizing clinical benefits.
• Partnerships: Strategic collaborations with payers, healthcare providers, and advocacy groups can facilitate broader access.

Financial Trajectory

Revenue Forecasts

Initial revenues for NAMZARIC are projected to be modest, given the conservative pace of DMT adoption, cautious regulatory environment, and market skepticism. However, if Phase III trial results confirm efficacy and safety, revenues could accelerate substantially.

Scenario 1 — Conservative:
USD 250 million in global sales by 2025, driven primarily by early adopters in North America and Europe, with slow uptake due to hesitancy and reimbursement hurdles.

Scenario 2 — Optimistic:
USD 1 billion or more by 2027, supported by positive clinical data, competitive pricing, and successful market education.

Cost Structure and Investment

Development costs for NAMZARIC, including research, clinical trials, regulatory submissions, and marketing, have been substantial. Marketing expenses will likely remain high as companies educate physicians and payers on disease-modifying benefits, especially amidst competition.

Profitability and Investment Implications

Profit margins will depend on drug pricing strategies, manufacturing costs, and negotiation outcomes with payers. Early profitability might be elusive, with significant investments needed to build a sustainable market share.

Market Risks and Challenges

• Regulatory Uncertainty: Delays or future restrictions if efficacy is questioned.
• Clinical Uncertainty: Mixed trial outcomes can diminish credibility and financial prospects.
• Market Saturation: Rapid development of similar or superior agents may constrain growth.
• Reimbursement Challenges: Payer skepticism could limit patient access and revenue.

Emerging Trends Impacting Market Trajectory

• Biomarker Development: Personalized medicine based on genetic or biomarker profiles could enhance patient stratification, improving clinical outcomes and market acceptance.
• Digital Health Integration: Wearable and cognitive monitoring tools can demonstrate treatment efficacy, supporting reimbursement.
• Policy Shifts: Governments’ initiatives for dementia care funding and inclusion in national health strategies may favor new therapies.

Key Takeaways

• NAMZARIC enters a rapidly expanding but highly competitive and uncertain AD treatment landscape.
• Its ultimate market success depends on demonstrable clinical benefits, regulatory progression, and strategic payer engagement.
• Early revenues will be modest but could scale rapidly if clinical trials translate into real-world efficacy.
• The evolving regulatory and reimbursement environments pose risks requiring proactive engagement.
• Innovation in personalized medicine and digital health tools offers opportunities to differentiate and accelerate adoption.

FAQs

1. What distinguishes NAMZARIC from existing Alzheimer’s therapies?
   Unlike symptomatic medications, NAMZARIC aims to modify disease progression by targeting amyloid pathology, potentially offering more substantial long-term benefits.

2. When is NAMZARIC expected to reach peak sales?
   Peak sales projections vary; a conservative estimate suggests 2027-2028, contingent upon clinical success, regulatory approval, and payer acceptance.

3. What are the main barriers to NAMZARIC’s market penetration?
   Regulatory delays, clinical efficacy uncertainties, high development and marketing costs, and payer skepticism are significant barriers.

4. How does the competitive landscape affect NAMZARIC’s prospects?
   Emerging agents like lecanemab and regulatory approvals of other DMTs could limit NAMZARIC’s market share unless it demonstrates superior efficacy, safety, or cost-effectiveness.

5. What strategic actions can maximize NAMZARIC's market potential?
   Focus on robust clinical trial data, early payer engagement, value-based pricing, and partnerships with healthcare entities can enhance market penetration.

Sources

1. Alzheimer’s Association. Alzheimer’s Disease Facts and Figures 2022
2. FDA. Alzheimer’s Disease: Developing Drugs for Treatment Guidance, 2022
3. EvaluatePharma. Alzheimer’s Disease Market Analysis, 2023
4. Biotechnology Innovation Organization. Advances in Alzheimer’s Therapeutics, 2022
5. World Health Organization. Global Dementia Report 2022