ARICEPT Drug Patent Profile

When do Aricept patents expire, 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-six 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:	285
Clinical Trials:	150
Patent Applications:	4,244
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
Vanderbilt University Medical Center	Early Phase 1
Inventage Lab., Inc.	Phase 1/Phase 2
G2GBio, Inc.	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	020690-002	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
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996

International Patents for ARICEPT

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

Country	Patent Number	Title	Estimated Expiration
Norway	20073482
Greece	3036553
Hungary	211165
World Intellectual Property Organization (WIPO)	2006070930
Norway	321267
European Patent Office	1116716

Supplementary Protection Certificates for ARICEPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296560	98C0015	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
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 Aricept (Donepezil)

Introduction

Aricept, also known as donepezil, is a widely used medication for the treatment of Alzheimer's disease and other forms of dementia. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting key trends, drivers, and forecasts.

Market Size and Growth

The global donepezil market has been experiencing steady growth driven by several factors. As of 2023, the market was valued at approximately $1.241 billion and is projected to reach $1.8225 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.5% during the forecast period of 2024-2030[4].

Drivers of Growth

Increasing Prevalence of Alzheimer's Disease

The rising incidence of Alzheimer's disease and other neurological disorders, particularly among the aging population, is a significant driver of the donepezil market. As the global population ages, the demand for medications like donepezil that help manage symptoms and slow the progression of the disease is increasing[4].

Technological and Scientific Advancements

Advancements in medical science and technology have improved the understanding of Alzheimer's disease mechanisms, leading to more effective treatment plans. This increased understanding supports the development and marketing of donepezil, enhancing its effectiveness and attractiveness to patients and healthcare professionals[4].

Regulatory and Healthcare Policies

Regulatory actions and healthcare policies play a crucial role in the market environment for donepezil. Strict regulations ensure the safety and quality of the drug, while government initiatives and favorable reimbursement policies facilitate access to healthcare treatments for patients with Alzheimer's disease. These factors contribute to the market's growth by building trust among patients and healthcare providers[4].

Key Players and Competitive Landscape

The donepezil market is competitive, with several major players including Eisai, Pfizer, Teva, Novartis, Apotex, Dr. Reddy's Laboratories, Sun Pharmaceutical, Hansoh Pharma, Cipla, ARK PHA.LTD, Jishengtang Pharma, and Luoxin. These companies invest heavily in research and development, marketing, and the launch of new dosage forms and formulations, which helps in expanding the market and improving patient outcomes[4].

Regional Market Trends

Global Market

The global donepezil market is diverse, with different regions exhibiting varying trends. For instance, the market in the United States is significant due to the high prevalence of Alzheimer's disease and the availability of advanced healthcare facilities. In contrast, markets in Asia and Latin America are growing rapidly due to increasing awareness and improving healthcare infrastructure[4].

European Market

In Europe, the trends vary by country. For example, France saw a significant decline in Alzheimer's disease drug sales, including donepezil, over the past decade due to changes in health policy and prescription practices. However, other countries like the UK have seen an increase in sales, while Germany has maintained stable sales levels[3].

Financial Performance

Revenue and Sales

Aricept, being a key drug in the donepezil market, has contributed significantly to the revenue of its manufacturers. For instance, Eisai, the original developer of Aricept, has seen substantial revenue from this drug. Although the patent for Aricept has expired, leading to the entry of generic versions, the drug still generates considerable revenue due to its established brand and patient loyalty[1].

Impact of Generic Versions

The expiration of the Aricept patent has led to the introduction of generic donepezil, which has affected the sales of the branded version. However, the overall market for donepezil continues to grow due to the increasing demand for Alzheimer's disease treatments. Generic versions have made the drug more accessible, but the branded version still maintains a significant market share due to its reputation and trust among patients and healthcare providers[1].

Future Outlook

Forecasted Growth

The donepezil market is expected to continue growing, driven by the increasing prevalence of Alzheimer's disease and the ongoing development of new treatment options. The forecasted CAGR of 5.5% from 2024 to 2030 indicates a robust growth trajectory for the market[4].

Emerging Trends

Emerging trends include the development of combination therapies and novel formulations that enhance the efficacy and safety of donepezil. Additionally, strategic marketing initiatives and R&D investments by pharmaceutical companies are expected to further expand the market and improve patient outcomes[4].

Key Takeaways

• The global donepezil market is valued at $1.241 billion as of 2023 and is expected to reach $1.8225 billion by 2030.
• The market is driven by the increasing prevalence of Alzheimer's disease, technological advancements, and favorable regulatory policies.
• Key players include Eisai, Pfizer, Teva, and others, with significant investments in R&D and marketing.
• Regional trends vary, with the US market being significant and European markets showing mixed trends.
• The financial performance of Aricept is strong despite the entry of generic versions, with ongoing revenue generation due to its established brand.

FAQs

Q: What is the current market size of the donepezil drug market? A: The global donepezil drug market was valued at approximately $1.241 billion in 2023[4].

Q: What is the projected growth rate of the donepezil market from 2024 to 2030? A: The donepezil market is expected to grow at a CAGR of 5.5% from 2024 to 2030[4].

Q: Who are the main players in the donepezil market? A: The main players include Eisai, Pfizer, Teva, Novartis, Apotex, Dr. Reddy's Laboratories, and others[4].

Q: How has the sales of Alzheimer's disease drugs, including donepezil, trended in France over the past decade? A: Sales of Alzheimer's disease drugs, including donepezil, have declined significantly in France over the past decade, primarily due to changes in health policy and prescription practices[3].

Q: What impact has the expiration of the Aricept patent had on its sales? A: The expiration of the Aricept patent has led to the introduction of generic versions, which has affected the sales of the branded version. However, the overall market for donepezil continues to grow due to increasing demand[1].

Sources

1. GlobalData: MARKET BRIEF - Alzheimer's Disease Market Report (2016-2026)
2. FY 2022 Full Year Financial Results: Materials and information provided in this announcement include current forecasts, targets, evaluations, estimates.
3. JAMA Health Forum: Ten-Year Trends in Sales of Alzheimer Disease Drugs in France
4. Valuates Reports: Donepezil Drug Market Research Report, Industry Forecast Analysis
5. H1 FY2023 Financial Results: Accelerating our transformation into a fully integrated biopharma company committed to helping patients in Japan and across the APAC region.