DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for donepezil hydrochloride; memantine hydrochloride and what is the scope of patent protection?

Donepezil hydrochloride; memantine hydrochloride is the generic ingredient in two branded drugs marketed by Amneal, Ani Pharms, Macleods Pharms Ltd, Xiamen Lp Pharm Co, and Abbvie, and is included in five NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride; memantine hydrochloride has sixty-seven patent family members in nineteen countries.

Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

International Patents:	67
US Patents:	6
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
Clinical Trials:	27
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
DailyMed Link:	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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

Sponsor	Phase
Rune Skovgaard Rasmussen	PHASE2
Herlev Hospital	PHASE2
NeuroSense Therapeutics Ltd.	Phase 2

See all DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

N06DX	Other anti-dementia drugs
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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	8,293,794		Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016	AB	RX	Yes	No	8,039,009*PED				Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	AB	RX	Yes	No	8,580,858
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016	AB	RX	Yes	No	8,058,291

Expired US Patents for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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	8,338,486
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	5,061,703*PED
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016	8,293,794
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	8,338,485

EU/EMA Drug Approvals for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20070116996	METHODS AND COMPOSITIONS FOR TREATMENT OF CNS DISORDERS
South Korea	101406456
Japan	2009173669	COMPOSITION CONTAINING SUSTAINED RELEASE COATING OR MATRIX AND NMDA RECEPTOR ANTAGONIST, AND METHOD FOR ADMINISTRATION OF SUCH NMDA ANTAGONIST TO SUBJECT
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 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Donepezil Hydrochloride and Memantine Hydrochloride

Last updated: July 28, 2025

Introduction

The global landscape of neurodegenerative disorder management, particularly Alzheimer’s disease (AD), hinges critically on pharmacotherapy advancements. Donepezil hydrochloride and memantine hydrochloride have become cornerstone agents, shaping market dynamics and influencing financial trajectories within the pharmaceutical sector. Analyzing their role offers insights into market growth, competitive positioning, and future opportunities.

Market Overview

Alzheimer's disease afflicts an estimated 55 million individuals worldwide, with projections reaching 78 million by 2030 [1]. As no curative therapy exists, symptomatic treatments like donepezil and memantine, which ameliorate cognitive decline, dominate the market. The aging population, increasing disease prevalence, and improved diagnostic protocols underpin rising demand.

Product Profiles and Therapeutic Significance

• Donepezil Hydrochloride: An acetylcholinesterase inhibitor approved by the FDA in 1996 for mild to moderate AD. It enhances cholinergic transmission, improving cognition and daily functioning. Its favorable tolerability and established efficacy sustain its market presence.

• Memantine Hydrochloride: An NMDA receptor antagonist approved in 2003 for moderate to severe AD, offering neuroprotective effects by modulating glutamate activity. Its utility extends to combination therapy with donepezil, augmenting treatment effectiveness.

Market Dynamics

Growing Demand Driven by Demographics

Population aging and early diagnosis drive strong market expansion. According to the World Health Organization, the incidence of AD is expected to double every two decades, creating persistent demand for these therapeutics [1].

Patent Expiry and Generic Competition

Patent expirations historically catalyze market shifts. Donepezil's patents expired in 2018, opening avenues for generic manufacturers. This proliferation has led to a significant reduction in pharmaceutical prices, increasing affordability but exerting pressure on branded sales.

Conversely, memantine’s patent expired in 2010; generic versions have expanded accessibility, boosting volume sales but suppressing profit margins for originators.

Innovation and Formulation Trends

Recent R&D focuses on combination therapies and novel delivery systems. Notably, fixed-dose combinations and sustained-release formulations aim to optimize therapeutic regimens, possibly extending market lifecycle and differentiating products.

Regulatory and Reimbursement Landscapes

Regulatory agencies facilitate market entry for generics, where affordability is prioritized. Reimbursement policies, especially in developed markets, influence patient access and indirectly impact revenues for both branded and generic formulations.

Market Share Distribution

In developed markets, branded drugs like Aricept (donepezil) retain substantial market share due to established clinical trust, despite generic competition. Memantine (Namenda) similarly maintains a foothold, especially in severe AD cases where combination therapy is recommended.

In emerging markets, affordability dictates reliance on generics, aligning revenues with volume rather than premium pricing.

Financial Trajectory Analysis

Revenue Trends

Post-patent expiry, revenues for donepezil declined significantly in developed markets, with estimates indicating an approximate 50% drop within two years [2]. Generic sales fill revenue gaps, but profit margins diminish. For memantine, similar patterns emerged post-2010, with revenues stabilizing at lower levels but compensating through increased volume.

Market Penetration and Growth

Despite patent expiries, global revenues for donepezil and memantine continue to grow, driven by increasing AD prevalence and diagnostic improvements. The World Alzheimer Report states the global market for AD medications, including these agents, is projected to reach USD 10 billion by 2025, growing at an annual CAGR of approximately 4% [3].

Innovative Pipelines and Strategic Investments

Pharmaceutical companies invest in next-generation drugs that target multiple pathways involved in AD. Investments in disease-modifying therapies may redefine the market trajectory, potentially overshadowing current symptomatic drugs.

Competitive Landscape

• Major pharmaceutical players such as Pfizer, Eisai, and Merz dominate the market.
• Generics and biosimilars have increased competition post-patent expiry.
• Strategic alliances focus on developing combination therapies and personalized medicine, aiming to sustain growth amid patent challenges.

Market Challenges and Opportunities

Challenges

• Efficacy Limitations: Current drugs provide symptomatic relief but do not address disease progression.
• Pricing Pressures: Generics and healthcare policies favor cost reduction.
• Regulatory Barriers: Slower approval processes for novel therapies may delay market shifts.

Opportunities

• Combination and Personalized Treatment: Precision medicine approaches could improve outcomes.
• Pipeline Innovations: Novel drug candidates targeting amyloid, tau, and neuroinflammation signal future growth.
• Emerging Markets: Growing awareness and affordability open untapped markets.

Implications for Stakeholders

Pharma Companies: Need to diversify portfolios, invest in pipeline development, and explore partnerships. Patent strategies and lifecycle management are critical to sustain revenues.

Investors: Should monitor pipeline progress, regulatory landscapes, and shifting market shares influenced by generics and generative innovations.

Healthcare Providers: Must adopt cost-effective, evidence-based treatments while anticipating future therapeutic advances.

Key Takeaways

• The aging global population drives sustained demand for donepezil and memantine, ensuring continued market relevance.
• Patent expiries significantly shifted revenues toward generics, compressing profit margins but expanding access and volume.
• Innovation in drug formulation, combination therapies, and disease-modifying agents presents growth avenues.
• Market dynamics are increasingly shaped by regulatory policies and healthcare reimbursement strategies.
• Strategic positioning, including pipeline investments and lifecycle management, is essential to maintain competitiveness and financial viability.

FAQs

1. How will patent expiries affect the profitability of donepezil and memantine?
Patent expiries in 2018 (donepezil) and 2010 (memantine) led to increased generic competition, reducing prices and gross margins for branded formulations. However, overall market volume growth offsets some profit declines, especially in emerging markets.

2. Are there upcoming alternatives to these drugs in Alzheimer's treatment?
Yes, numerous disease-modifying therapies and novel agents targeting amyloid and tau proteins are in late-stage trials, potentially transforming treatment paradigms.

3. How does healthcare policy influence the market trajectory of these drugs?
Policies favoring generic substitution and cost containment reduce revenue for branded drugs but improve access. Reimbursement landscapes vary, impacting patient affordability and market share.

4. What role do combination therapies play in the future of AD treatment?
Combination therapies, integrating donepezil and memantine or novel agents, aim to improve efficacy and delay disease progression, potentially expanding market opportunities and extending product life cycles.

5. What emerging geographic markets present growth prospects?
Emerging markets in Asia, Latin America, and Africa show increasing AD prevalence, rising awareness, and affordability, offering significant growth potential for both branded and generic formulations.

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References

[1] World Health Organization. Dementia Fact Sheet. 2021.
[2] IQVIA Institute. The Global Use of Medicine in 2020. 2021.
[3] Alzheimer's Disease International. World Alzheimer Report 2022.

Note: Data and forecasts are indicative and based on industry reports and market analyses as of 2023.