ARICEPT Drug Patent Profile

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

Aricept is a drug marketed by Eisai Inc and is included in four NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in fifteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aricept

A generic version of ARICEPT was approved as donepezil hydrochloride by AUROBINDO on May 31^st, 2011.

Summary for ARICEPT

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	152
Patent Applications:	4,660
Drug Prices:	Drug price information for ARICEPT
What excipients (inactive ingredients) are in ARICEPT?	ARICEPT excipients list
DailyMed Link:	ARICEPT at DailyMed

See drug prices for ARICEPT

See drug sales revenues for ARICEPT

Recent Clinical Trials for ARICEPT

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

Sponsor	Phase
University of Virginia	PHASE2
Changchun University of Chinese Medicine	EARLY_PHASE1
Vanderbilt University Medical Center	Early Phase 1

See all ARICEPT clinical trials

Pharmacology for ARICEPT

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Paragraph IV (Patent) Challenges for ARICEPT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARICEPT	Tablets	donepezil hydrochloride	23 mg	022568		2013-07-09

US Patents and Regulatory Information for ARICEPT

ARICEPT is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	SOLUTION;ORAL	021719-001	Oct 18, 2004		DISCN	Yes	No
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010	AB	RX	Yes	Yes			Y
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	AB	RX	Yes	No
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	AB	RX	Yes	Yes
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004		DISCN	Yes	No
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004		DISCN	Yes	No

Expired US Patents for ARICEPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996

International Patents for ARICEPT

See the table below for patents covering ARICEPT around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3855028
Japan	2012144568	METHOD FOR STABILIZING ANTI-DEMENTIA DRUG
Germany	19775093
Australia	731282
German Democratic Republic	283377	VERFAHREN ZUR HERSTELLUNG ZYKLISCHER AMINVERBINDUNG
South Korea	100545851

Supplementary Protection Certificates for ARICEPT

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
0296560	98C0015	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228

Market Dynamics and Financial Trajectory for Aricept (Donepezil)

Last updated: December 31, 2025

Executive Summary

Aricept (donepezil) remains a cornerstone therapy in the management of Alzheimer's disease (AD), with a market presence spanning over two decades. Its market dynamics are influenced by factors including demographic aging, competing therapies, regulatory landscapes, and patent expirations. The drug’s financial trajectory is characterized by steady revenues, challenges from generic competition, and evolving global adoption rates. This analysis departs with a comprehensive overview of Aricept's therapeutic profile, followed by in-depth insights into market drivers, revenue trends, competitive landscape, regulatory influences, and future outlook.

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What is Aricept, and How Does It Fit in Alzheimer's Management?

Aricept (donepezil) is an acetylcholinesterase inhibitor approved for mild to severe Alzheimer's disease. It enhances cholinergic transmission by increasing extracellular acetylcholine concentrations, addressing cognitive deficits associated with AD.

Key Specs	Details
Indication	Mild to severe Alzheimer's disease (FDA-approved)
Formulations	5 mg, 10 mg tablets; orally disintegrating tablets available
Mechanism of Action	Acetylcholinesterase inhibition
Approval Date	1996 (FDA)

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What Are the Key Market Drivers Influencing Aricept?

Demographics and Disease Prevalence

• Global Alzheimer’s prevalence projected to reach approximately 131 million by 2050 ([1])—a significant driver for drug demand.
• Aging populations in North America, Europe, and Asia contribute to increased prescription rates, especially among populations aged 65+.

Diagnosed Patient Population

• An estimated 15 million Alzheimer’s patients globally are under treatment with cholinesterase inhibitors, with Aricept comprising approximately 60-70% of prescriptions (IQVIA, 2022).

Regulatory and Reimbursement Policies

• Stringent approvals and national reimbursement schemes influence access.
• USA: Medicare coverage favors traditional branded prescriptions; however, generic entry affects pricing.

Competitive Landscape

• Entry of generic donepezil products post-patent expiry (~2010s) has intensified price competition.

Innovation and Pipeline Developments

• Adjunctive therapies, including NMDA receptor antagonists (e.g., Namenda), complement Aricept, shaping prescribing patterns.

Market Challenges

• Limited disease-modifying options; current drugs only manage symptoms.
• Slow adoption of disease-modifying therapies constrains long-term expansion.

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How Has Aricept’s Revenue Trajectory Evolved Over Time?

Historical Revenue Data (Approximate Figures)

Year	Brand Name Revenue (USD millions)	Notes
2000s	$1.2 billion (peak in early 2000s)	Dominant market share initially
2010	~$700 million	Patent expiry leading to generic entry
2020	~$300 million	Continued decline due to generics and biosimilars
2022	~$180 million	Further decline, with some stabilization

Impact of Patent Expiry and Generics

• 2010: U.S. patent expiration led Pfizer and Eisai to launch generic variants.
• Post-2010: Revenue declines accelerated, with generics capturing significant market share.
• 2022: Generics account for 85-90% of prescriptions ([2]).

Geographical Revenue Breakdown

Region	Market Share of total revenue	Notes
North America	50%	Largest market; high reimbursement rate
Europe	30%	Fragmented markets, regulatory hurdles
Asia-Pacific	15%	Growing adoption, price-sensitive
Rest of the World	5%	Emerging markets

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What Is the Competitive Landscape and Patent Implications?

Major Competitors

Product	Class	Market Share	Notes
Aricept (Donepezil)	Acetylcholinesterase inhibitor	~60-70% (prescription volume)	Leading globally
Rivastigmine (Exelon)	Acetylcholinesterase & butyrylcholinesterase inhibitor	20-25%	Alternative treatment
Galantamine (Razadyne)	Similar mechanism	10-15%	Market share smaller

Generic Competition

• Patent expiry (~2010) led to widespread availability of generics, drastically reducing branded sales and price points.

Implication	Details
Price erosion	Branded Aricept prices decreased by approx. 70% post-generic entry
Market penetration	Generics dominate prescription volume
Manufacturer strategies	Some manufacturers introduced fixed-dose combinations or formulations to maintain market share

Patent Status and Future Exclusivities

• Patent protections for Aricept have expired in all major markets.
• Currently, no second-generation IP protections prevent generic proliferation.

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How Do Regulatory Policies Affect Aricept's Market?

Global Regulatory Framework

• Stringent approval processes in the US, EU, and Japan influence access.
• Reimbursement policies directly impact prescribing behaviors.

Favorable Policies

• Some countries provide subsidies for symptomatic AD treatment, bolstering sales.
• Accelerated approval pathways for new formulations or indications.

Market Access Barriers

• Limited provision of new indications restricts revenue expansion.
• Variability in approval and reimbursement across countries affects global sales.

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What Is the Future Outlook for Aricept and Its Market?

Emerging Trends

• Shift toward combination therapies (e.g., donepezil with memantine) could impact monotherapy sales.
• Biomarker-driven diagnosis and earlier intervention could alter prescribing patterns.
• Pipeline developments: Currently, no market-approved disease-modifying agents replace symptomatic treatments like Aricept.

Potential Market Expansion

Area	Opportunity	Challenges
Developing countries	Growing diagnosed population	Price sensitivity, regulatory hurdles
New formulations	Improved adherence (e.g., transdermal patches)	Clinical validation required

Forecasted Revenue (Next 5–10 years)

Projection	Estimate (USD millions)	Assumptions
Stabilization	~$100–150 million	Due to generics, continued market share decline, but some growth in emerging markets
Potential Upside	Conditional on new formulations or adjunctive therapies	Announcements of innovation could alter trajectory

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Deep-Dive Comparison: Aricept vs. Alternative Therapies

Parameter	Aricept (Donepezil)	Rivastigmine	Galantamine	Memantine (Namenda)
Mechanism	Cholinesterase inhibition	Cholinesterase + butyrylcholinesterase	Cholinesterase inhibition, nicotinic modulation	NMDA receptor antagonist
Approval Year	1996	2000	2001	2003
Formulations	Oral, disintegrating	Oral, transdermal	Oral	Oral
Efficacy	Moderate	Moderate	Moderate	Moderate to severe stages
Market Share (approx.)	60-70%	20-25%	10-15%	10-20%
Pricing (USD per dose)	$2–3	$2–4	$2–3	$3–5

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Key Takeaways

• Market decline: Aricept’s revenue has experienced significant contraction post-2010 due to patent expiry and generic competition, yet it remains a dominant symptomatic treatment globally.
• Demographic drivers: Aging populations sustain demand in emerging markets; developed markets' adoption is plateauing.
• Competitive pressures: Generics claim the majority of prescriptions, forcing price reductions; innovative formulations and combination therapies are being explored.
• Regulatory landscape: Variations in approval and reimbursement policies globally influence adoption and sales.
• Future prospects: Market stabilization expected; growth depends on developing novel formulations, expanding into emerging markets, and potentially combination therapies.

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FAQs

1. Will Aricept regain market share against generics?
Limited likelihood unless new formulations or indications are developed. Market share stabilization may occur through improved adherence products, such as transdermal patches, or combination therapies.

2. Are there new drugs in the pipeline that could replace Aricept?
Current pipeline of disease-modifying drugs remains uncertain; emerging symptomatic therapies focus on biomarkers and early intervention but have yet to replace established cholinesterase inhibitors.

3. How does the global age demographic trend impact Aricept?
An aging global population is a key driver; by 2050, the number of dementia cases is expected to nearly double, supporting sustained demand.

4. What role do reimbursement policies play in Aricept’s sales?
Reimbursement significantly influences prescribing behaviors; countries with comprehensive coverage tend to maintain higher utilization rates despite generic competition.

5. How do costs and price pressures affect Aricept’s profitability?
Price erosion post-generic entry has markedly reduced margins, compelling manufacturers to innovate or diversify product offerings to preserve profitability.

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References

1. Alzheimer's Association. (2022). 2022 Alzheimer's Disease Facts and Figures.
2. IQVIA. (2022). Prescription Audit Data.
3. U.S. Food & Drug Administration. (1996). Aricept (donepezil) approval details.
4. World Health Organization. (2021). Dementia Fact Sheet.
5. MarketWatch. (2022). Alzheimer’s disease therapeutics market analysis.

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In conclusion, Aricept’s market remains vital yet challenged by patent expirations and generics. The future hinges on innovation, strategic market expansion, and evolving treatment paradigms that could modify its longstanding trajectory. Business professionals should monitor regulatory shifts, pipeline developments, and demographic trends to navigate this landscape effectively.