DONEPEZIL HYDROCHLORIDE - Generic Drug Details

What are the generic drug 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, Aiping Pharm Inc, Chartwell Rx, Hisun Pharm Hangzhou, Macleods Pharms Ltd, 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 eighteen 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:	18
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
Rune Skovgaard Rasmussen	PHASE2
Herlev Hospital	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
Wockhardt	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	091267-001	May 31, 2011		DISCN	No	No
Alembic Pharms Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201724-002	Feb 25, 2013	AB	RX	No	No
Aurobindo	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090056-002	May 31, 2011	AB	RX	No	No
Prinston Inc	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	200292-001	May 31, 2011	AB	RX	No	No
Sun Pharm Inds	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090493-002	May 31, 2011		DISCN	No	No
Aiping Pharm Inc	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090290-001	May 31, 2011		DISCN	No	No
Rising	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202114-001	Jul 5, 2013	AB	RX	No	No

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
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996

International Patents for DONEPEZIL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20190034601
South Korea	102406528
South Korea	102545643
European Patent Office	3490541
Japan	7251033
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
Japan	2008525313

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: November 22, 2025

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Introduction

Donepezil Hydrochloride, marketed primarily under the brand name Aricept, is a cholinesterase inhibitor approved for the symptomatic treatment of mild to moderate Alzheimer’s disease. Since its approval by the FDA in 1996, the drug has played an increasingly vital role in managing cognitive decline associated with neurodegenerative disorders. This analysis explores the evolving market dynamics and financial trajectory of Donepezizil Hydrochloride, considering factors such as regulatory landscapes, competitive environment, patent challenges, clinical developments, and emerging market trends.

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Market Dynamics

1. Growing Global Alzheimer’s Disease Burden

The global prevalence of Alzheimer’s disease (AD) has surged, driven by aging populations. The World Health Organization (WHO) estimates over 55 million people worldwide live with dementia, primarily AD, with projections reaching 78 million by 2030 and 139 million by 2050 [1]. This demographic shift fuels persistent demand for symptomatic therapies such as Donepezizil.

2. Therapeutic Positioning and Competitive Landscape

Donepezil remains a first-line treatment for early to moderate AD, attributed to its proven efficacy and well-understood safety profile. Despite the advent of alternative agents like Rivastigmine and Galantamine, Donepezil’s once-daily dosing and extensive clinical history sustain its market prominence.

However, the market faces threats from disease-modifying therapies (DMTs) under development, aiming to alter disease progression rather than solely alleviate symptoms. Monoclonal antibodies like Aducanumab (approved by FDA in 2021) signify a paradigm shift, potentially diminishing the long-term market for purely symptomatic agents (though current DMTs are expensive and restricted initially).

3. Patent Expirations and Generic Competition

Patents protecting Donepezil’s formulations began expiring around 2012, leading to the proliferation of generic versions. According to IQVIA data, generics constitute approximately 80-90% of the global donepezil market, exerting considerable downward pressure on prices.

This increased competition has resulted in reduced revenue for originator companies but expanded access and adoption in emerging markets, where affordability remains critical.

4. Regulatory and Legal Challenges

Patent litigation and regulatory hurdles continue to influence market dynamics. While the original patents have expired, secondary patents on specific formulations or delivery methods occasionally delay generic entry or allow brand companies to sustain higher prices temporarily.

Regulatory agencies worldwide have approved domestically produced generics, further compounding the competitive landscape and pressuring profit margins.

5. Geographic Expansion and Market Penetration

Although North America and Europe represent mature Donepezil markets, Asia-Pacific and Latin America present significant growth opportunities due to increasing AD prevalence and healthcare infrastructure expansion. Furthermore, initiatives promoting earlier diagnosis boost treatment rates, enlarging potential market size.

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Financial Trajectory

1. Revenue Trends

Pre-patent expiry, Donepezil generated peak revenues exceeding $2 billion annually (2010-2012) for its original manufacturers. Post-patent, revenues declined substantially due to generic competition, with current estimates indicating a market value of approximately $300-500 million globally [2].

Despite the revenue decline, the drug remains a high-volume, low-cost medication, providing consistent cash flow for established pharmaceutical firms.

2. Pricing Strategies and Market Access

Generic competition has driven prices down by up to 80-90%, especially in price-sensitive regions. Manufacturers employ strategies such as discounts, flexible formularies, and inclusion in government-funded programs to maintain market share.

Innovator companies sometimes use patent settlements or exclusivity agreements to prolong market presence, though these strategies are increasingly scrutinized under legal frameworks.

3. Impact of New Formulations and Combination Therapies

While traditional Donepezil formulations remain dominant, pharmaceutical companies explore extended-release formulations and combination drugs (e.g., Donepezil with Memantine) to differentiate offerings and command premium pricing. Nonetheless, such innovations face regulatory hurdles and added development costs.

4. R&D Investments and Future Outlook

Investment in research aims to improve delivery, reduce side effects, and develop DMTs. The pipeline includes novel cholinesterase inhibitors with improved bioavailability or reduced peripheral side effects; however, successful commercialization remains uncertain.

Financial forecasts suggest that, absent paradigm shifts, the long-term revenue for Donepezil will continue to decline gradually, stabilizing at current levels barring new indications or formulations.

5. Emerging Markets and Access Programs

In low- and middle-income countries, government subsidization and international aid programs sustain sales volumes. These markets also present opportunities for increased penetration, mitigating revenue erosion in developed regions.

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Key Market Trends Impacting Financial Trajectory

• Aging Population: Persistent and growing, ensuring a steady demand for symptomatic AD therapies.
• Generic Competition and Price Erosion: Significant impact starting from 2012, leading to declining revenues.
• Emerging Therapeutics: Shift towards disease-modifying agents could cannibalize traditional sales.
• Market Expansion in Asia and Latin America: New opportunities for increased sales volume.
• Innovation in Delivery and Combination Therapies: Potential to sustain or grow revenues through differentiation.

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Conclusion

The market for Donepezil Hydrochloride exhibits a mature, highly competitive landscape experiencing steady decline post-patent expiration. While aging demographics sustain baseline demand, the advent of innovative treatments and generic competition threaten longer-term profitability. Companies focusing on geographic expansion, formulation improvements, and strategic collaborations may offset some revenue decline. However, pharmaceutical stakeholders must navigate patent expirations, price pressures, and evolving therapeutic paradigms proactively to optimize financial outcomes.

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Key Takeaways

• Market maturity and patent expiries have significantly reduced revenue, with generics dominating sales.
• Demographic trends—notably aging populations—maintain consistent demand, particularly in emerging markets.
• Emerging drug therapies, including DMTs and combination formulations, pose competitive risks.
• Pricing pressures necessitate strategic market access, especially in resource-limited settings.
• Innovation in formulations and expanding indications are crucial for future revenue sustainability.

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FAQs

1. How has patent expiration affected Donepezil’s market?
Patent expirations led to widespread generic manufacturing, drastically reducing prices and revenues—from over $2 billion pre-2012 to current estimates of less than $500 million globally. The shift increased market access but eroded profit margins for originator firms.

2. What are the growth prospects for Donepezil in emerging markets?
Rapid demographic aging, increasing healthcare infrastructure, and government initiatives improve access, making emerging markets vital growth nodes, despite intense price competition.

3. Are new formulations or combination therapies likely to revive Donepezil’s revenues?
Potentially. Extended-release formulations and combination drugs (e.g., with Memantine) could command premium prices and extend product lifecycle, but regulatory hurdles and clinical validation are challenges.

4. How do disease-modifying therapies impact Donepezil’s future?
DMTs, currently in developmental stages, aim to alter disease progression, threatening the market for symptomatic agents like Donepezil if they demonstrate superior efficacy and safety profiles in large trials.

5. What strategic moves should companies consider to maximize Donepezil’s value?
Investing in formulation innovation, exploring new indications, expanding into underserved markets, and forging strategic partnerships are key to sustaining revenue amid competitive pressures.

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References

[1] World Health Organization. (2021). Dementia Fact Sheet.
[2] IQVIA. (2022). Global Pharmaceutical Market Data.