Donepezil hydrochloride - Generic Drug Details

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

Donepezil hydrochloride is the generic ingredient in six branded drugs marketed by Eisai Inc, Corium, Chartwell Rx, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Novitium Pharma, Osmotica Pharm Us, Ph Health, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, Zydus Lifesciences, Zydus Pharms, Amneal, Ani Pharms, Xiamen Lp Pharm Co, and Abbvie, and is included in fifty-seven NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride has one hundred and twenty-eight patent family members in sixteen countries.

There are thirty drug master file entries for donepezil hydrochloride. Thirty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for donepezil hydrochloride

International Patents:	128
US Patents:	24
Tradenames:	6
Applicants:	45
NDAs:	57
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	333
Patent Applications:	7,382
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for donepezil hydrochloride
What excipients (inactive ingredients) are in donepezil hydrochloride?	donepezil hydrochloride excipients list
DailyMed Link:	donepezil hydrochloride at DailyMed

Recent Clinical Trials for donepezil hydrochloride

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

Sponsor	Phase
New York State Psychiatric Institute	PHASE2
Herlev Hospital	PHASE2
Rune Skovgaard Rasmussen	PHASE2

See all donepezil hydrochloride clinical trials

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET; ORAL
		5MG	TABLET; ORAL
		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

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for donepezil hydrochloride

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

Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARICEPT	Tablets	donepezil hydrochloride	23 mg	022568		2013-07-09
ARICEPT ODT	Orally Disintegrating Tablets	donepezil hydrochloride	5 mg and 10 mg	021720	1	2010-06-30

US Patents and Regulatory Information for donepezil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202782-001	Oct 30, 2015	AB	RX	No	No
Sun Pharm Industries	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	077975-002	Dec 11, 2009		DISCN	No	No
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	AB	RX	Yes	No	8,039,009*PED				Y
Heritage Pharma	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	077344-001	May 31, 2011		DISCN	No	No
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		RX	Yes	Yes	10,307,379		Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016	AB	RX	Yes	No	8,293,794		Y

Expired US Patents for donepezil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	4,895,841
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004	4,895,841
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004	4,895,841
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	6,372,760
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	6,245,911
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	4,895,841

International Patents for donepezil hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3490559	SYSTÈMES D'ADMINISTRATION TRANSDERMIQUE À PHARMACOCINÉTIQUE BIOÉQUIVALENT À L'ADMINISTRATION ORALE (TRANSDERMAL DELIVERY SYSTEMS WITH PHARMACOKINETICS BIOEQUIVALENT TO ORAL DELIVERY)
Singapore	11201805570W	SYSTEMS AND METHODS FOR LONG TERM TRANSDERMAL ADMINISTRATION
China	109789134	与口服递送药代动力学生物等效的透皮递送系统 (TRANSDERMAL DELIVERY SYSTEMS WITH PHARMACOKINETICS BIOEQUIVALENT TO ORAL DELIVERY)
Japan	2019523268	塩薬物のｉｎ ｓｉｔｕでの塩から中性の薬物変換による、低溶解度または不安定非イオン化中性薬物の経皮配合物および送達方法
Israel	303255	מערכות ושיטות למתן דרך העור לטווח ארוך (Systems and methods for long term transdermal administration)
South Korea	20220082929	아민 약물의 나트륨 바이카보네이트 제자리 전환 구동된 경피성 전달 (SODIUM BICARBONATE IN SITU CONVERSION DRIVEN TRANSDERMAL DELIVERY OF AMINE DRUG)

Supplementary Protection Certificates for donepezil hydrochloride

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
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 Donepezil Hydrochloride

Last updated: July 28, 2025

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Introduction

Donepezil hydrochloride, marketed globally as Aricept among other brand names, remains a cornerstone in the management of Alzheimer’s disease, a neurodegenerative disorder with growing prevalence. As the first-line cholinesterase inhibitor approved for mild to moderate Alzheimer’s, its market holds a distinctive position within the global neuropharmacology landscape. This analysis explores the underlying market forces and financial trends shaping the trajectory of donepezil hydrochloride, leveraging recent data to inform strategic decision-making for stakeholders.

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Global Market Overview

Market Size and Growth Rate

The global Alzheimer’s disease therapeutics market, valued at approximately USD 6 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of 7-8% through 2030, driven predominantly by increased aging populations and heightened diagnostic awareness (1). Donepezil hydrochloride, accounting for approximately 40% of this market segment, is expected to maintain its dominant position for the foreseeable future.

Historical sales data indicate that the donepezil market volume reached around 10 million units in 2022, with global revenues approximating USD 2.4 billion. The market’s expansion correlates directly with rising Alzheimer’s prevalence, estimated to affect over 55 million individuals worldwide as of 2023, projected to more than double by 2050 (2).

Geographical Dynamics

North America currently leads with nearly 50% of global donepezil sales, benefitting from early adoption, extensive healthcare infrastructure, and high disease awareness. Europe follows, with similar factors influencing its sustained demand. Meanwhile, Asia-Pacific exhibits rapid growth potential, attributed to aging demographics and increasing healthcare expenditure, albeit constrained by pricing sensitivities and regulatory hurdles (3).

Market Drivers

Epidemiological Trends

The escalating incidence of Alzheimer’s disease is the primary driver. The WHO reports Alzheimer’s as the seventh leading cause of death worldwide, with the elderly population (above 65) burgeoning globally. The increasing prevalence directly amplifies demand for symptomatic treatments like donepezil.

Regulatory Approvals

Existing approval for donepezil across multiple jurisdictions sustains steady market access. Additionally, ongoing research and potential new indications—such as off-label use for other cognitive disorders—could further broaden its utilization.

Healthcare Infrastructure

Enhanced diagnostic capabilities, particularly in developed nations, contribute to early detection and treatment initiation, bolstering market volume. Initiatives to increase awareness and screening programs further support sustained demand.

Market Challenges

Generic Competition

Patent expirations, notably the expiration of the original patent in the U.S. in 2010, precipitated a surge in generic versions, significantly reducing prices and profit margins. Despite this, branded formulations maintain market share through strategic marketing and formulation differentiation, such as extended-release versions.

Efficacy and Safety Concerns

While effective in symptom management, donepezil does not alter disease progression. Adverse effects, including gastrointestinal disturbances and potential cardiotoxicity, may lead to discontinuation, influencing prescribing patterns.

Emerging Therapeutics

The development pipeline includes disease-modifying agents, monoclonal antibodies (e.g., lecanemab), which could diminish the reliance on symptomatic drugs like donepezil. These novel therapies threaten to cannibalize market share over the long term.

Financial Trajectory and Future Outlook

Revenue Projections

Despite generic competition, established brands of donepezil are projected to generate USD 1.2-1.5 billion annually through 2025. This stability stems from manufacturing infrastructure, clinician familiarity, and formulary listings. However, a gradual decline is anticipated beyond 2025 as newer therapies gain approval.

Pricing Trends

Pricing pressures persist, particularly with generic proliferation; however, innovator companies seek differentiation via formulation advances—such as Once-Daily Extended-Release (ER) versions—and combination therapies.

Research and Development Investment

Investments in pharmacovigilance, personalized medicine approaches, and new formulations aim to extend product lifecycle and improve tolerability. In addition, collaboration with biotech firms to explore adjunctive or combination therapies represents a strategic avenue.

Regulatory and Market Entry Barriers

Market entry barriers include stringent regulatory requirements, patent landscapes, and clinical trial costs. Entry into emerging markets often involves navigating complex registration processes and price controls, impacting profit margins.

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Strategic Implications for Stakeholders

• Pharmaceutical companies should monitor emerging disease-modifying therapies, investing in product line extensions and improved delivery systems to maintain relevance.
• Investors must weigh the declining revenue potential post-patent expiry against ongoing sales stabilization driven by market penetration.
• Regulatory agencies are pivotal in facilitating timely approvals of innovative formulations and combination regimens that could alter the current financial trajectory.

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Conclusion

The market for donepezil hydrochloride remains robust amidst a shifting therapeutic landscape. While aging demographics serve as an enduring demand driver, evolving treatment paradigms, competitive pressures, and regulatory factors hint at eventual market contraction. Stakeholders should strategize around innovation, lifecycle management, and market expansion into emerging economies to sustain growth over the medium term.

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Key Takeaways

• The global donepezil market is poised for steady growth until 2025, driven primarily by aging populations and increased diagnosis rates.
• Generic competition has significantly reduced prices, pressuring profitability but maintaining substantial revenue streams.
• Emerging disease-modifying therapies threaten to displace symptomatic treatments in the long term.
• Differentiation strategies, including extended-release formulations and combination therapies, are essential for sustained market share.
• Entering emerging markets offers growth prospects, albeit with noted regulatory and pricing challenges.

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FAQs

1. How does patent expiration influence donepezil’s market share?
Patent expiration introduces generic competitors, leading to substantial price reductions and erosion of profits for branded formulations. Despite this, brand loyalty and formulation innovations help preserve a segment of the market.

2. What are the main limitations of donepezil in treating Alzheimer’s disease?
Donepezil offers symptomatic relief without altering disease progression. Additionally, adverse effects and variable patient response can limit its long-term use.

3. Which emerging therapies pose the greatest threat to donepezil’s market?
Disease-modifying agents such as monoclonal antibodies (e.g., lecanemab) targeting amyloid plaques present significant future competition, especially if they demonstrate disease-stopping efficacy.

4. How are pricing pressures affecting donepezil revenues?
Pricing pressures from generics and healthcare payers have reduced per-unit revenue, prompting companies to seek formulation innovations and therapeutic combinations to maintain profitability.

5. What strategies can pharmaceutical companies adopt to sustain donepezil’s market presence?
Companies can focus on developing new formulations (e.g., extended-release), exploring combination therapies, expanding into emerging markets, and investing in clinical research for new indications or improving tolerability.

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References

1. MarketWatch. "Global Alzheimer’s Disease Therapeutics Market Size, Share & Trends Analysis Report." 2022.
2. World Health Organization. "Dementia Fact Sheet." 2023.
3. Grand View Research. "Neuropharmacology Market Outlook." 2022.