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 two 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:	2
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
Herlev Hospital	PHASE2
Rune Skovgaard Rasmussen	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	206439-002	Dec 23, 2014	AB	RX	Yes	Yes	8,039,009*PED				Y
Xiamen Lp Pharm Co	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	216901-001	Jul 15, 2025	AB	RX	No	No
Amneal	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208328-003	Feb 27, 2025	AB	RX	No	No
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	AB	RX	Yes	No	8,039,009*PED				Y

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	206439-001	Dec 23, 2014	8,338,486
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	206439-001	Dec 23, 2014	8,293,794
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	8,580,858

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	101301429
European Patent Office	2343057	Procédé et composition pour l'administration d'un antagoniste du récepteur NMDA à un sujet (Method and composition for administering an NMDA receptor antagonist to a subject)
Australia	2005309601	Composition comprising a sustained release coating or matrix and an NMDA receptor antagonist, method for administration such NMDA antagonist to a subject
European Patent Office	1734920	COMBINAISON D'UN ANTAGONISTE DU RECEPTEUR NMDA ET D'UN INHIBITEUR MAO OU GADPF POUR LE TRAITEMENT DES TROUBLES PSYCHIATRIQUES (COMBINATION OF A NMDA RECEPTOR ANTAGONIST AND AN 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

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 13, 2026

Market Dynamics and Financial Trajectory for Donepezil Hydrochloride and Memantine Hydrochloride

Overview

Donepezil Hydrochloride and Memantine Hydrochloride are leading drugs used in the treatment of Alzheimer’s disease. Their market performance reflects evolving treatment protocols, patent status, and competitive landscape. Projected revenue trajectories depend on patent expiries, generic entry, and adoption rates.

Market Size and Growth Trends

The global Alzheimer’s drug market was valued at approximately $10 billion in 2022. Donepezil and Memantine collectively account for roughly 70% of this market. These drugs are prescribed for mild to moderate (donepezil) and moderate-to-severe stages (memantine) of the disease.

Market growth is driven by:

• Aging populations in developed markets.
• Increased diagnosis rates.
• Continuing R&D in combination therapies.

Patent and Regulatory Status

Donepezil Hydrochloride:

• Patent expiry occurred in the U.S. in 2017, opening the market to generics.
• It remains under patent protection in select jurisdictions until 2024.
• Regulatory approvals are largely stable, with no significant new formulations.

Memantine Hydrochloride:

• Patented until 2015, with generic versions entering thereafter.
• It is off-patent globally now.
• New formulations, such as sustained-release forms, are under development.

Market Players and Competitive Landscape

Major manufacturers include Eisai Co., Ltd., Novartis AG (formerly under license), and generics manufacturers producing unbranded versions. Market share has shifted post-patent expiry, favoring generics which compete primarily on price and bioequivalence.

Revenue Projections and Financial Trajectory

Pre-Patent Expiry Years (2010–2017):

• Revenue for donepezil peaked at approximately $3.8 billion globally in 2013.
• Memantine generated around $1.2 billion in 2015.

Post-Patent Expiry Trends (2018–2022):

• Donepezil sales declined by approximately 45% due to generic competition.
• Generic sales volume increased, but overall revenue declined to roughly $2.1 billion by 2022.
• Memantine's sales stabilized around $600–700 million, with a slight decline due to newer therapies and evolving standards of care.

Future Trajectory:

• The market is expected to contract further by 10–15% annually over the next five years due to increasing generic penetration, unless new formulations or indications emerge.
• However, growth may be bolstered by combination therapies or disease-modifying drugs entering late-stage clinical trials.

Key Drivers and Risks

Drivers:

• Aging demographics increasing prevalence.
• National health systems emphasizing early diagnosis and treatment.
• Off-label use and expanded indications.

Risks:

• Patent litigation delaying generic entry.
• Competitive pressures from emerging disease-modifying therapies.
• Regulatory hurdles for novel formulations.

Emerging Trends and Opportunities

• Development of extended-release formulations aims to improve adherence.
• Combination therapies with other neuroprotective agents are in early stages.
• Biomarker-driven treatment selection could increase drug efficacy and market share.

Financial Outlook Summary

Aspect	Donepezil Hydrochloride	Memantine Hydrochloride
2013 Peak Revenue	~$3.8 billion	~$1.2 billion
2022 Revenue	~$2.1 billion	~$600 million
Post-Patent Revenue	Declining	Stabilized then declining
Future Growth	Limited without new formulations	Limited, contingent on new formulations or indications

Regulatory and Competitive Outlook

Generic competition will dominate the market with limited growth forecasts unless new patent protections or formulations are introduced. Investment opportunities may exist in drug reformulations, combination therapies, or biomarkers for personalized treatment.

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Key Takeaways

• The market for Donepezil and Memantine has declined post-patent expiry but remains sizable due to the prevalence of Alzheimer’s.
• Revenue will likely decline further, driven by generic competition and evolving treatment options.
• Innovation through formulations and combination therapies remains critical for future growth.
• The generics market has increased accessibility but exerted substantial price pressure.
• Monitoring clinical trial outcomes for emerging therapies will be essential for assessing future market shifts.

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FAQs

1. When did patents for Donepezil and Memantine expire?
Donepezil’s patent in the U.S. expired in 2017, with ongoing protection in some regions until 2024. Memantine patents expired globally by 2015.

2. How much revenue does the market generate annually now?
Global revenues for these drugs are approximately $2.7 billion combined, with declining trends expected.

3. Are new formulations or indications likely to revive market growth?
Yes. Sustained-release formulations and combination therapies could provide growth opportunities, contingent on successful clinical trials.

4. What risks do manufacturers face amid generic competition?
Price erosion, reduced profit margins, and regulatory delays pose risks. Companies differentiating through new formulations or indications mitigate these risks.

5. How does the regulatory environment influence market prospects?
The approval process impacts development timelines for reformulations or novel indications. Regulatory hurdles can delay market entry of innovative therapies.

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References

[1] MarketWatch, "Global Alzheimer’s Disease Therapeutics Market Size, Share & Trends," 2023.
[2] Fitch Solutions, "Pharmaceuticals Industry Outlook," 2023.
[3] U.S. FDA, "Drug Patent Expirations," 2022.
[4] IQVIA, "Global Pharmaceutical Market Data," 2022.