ARICEPT ODT Drug Patent Profile

When do Aricept Odt patents expire, and what generic alternatives are available?

Aricept Odt is a drug marketed by Eisai Inc and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aricept Odt

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

Summary for ARICEPT ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	285
Clinical Trials:	150
Patent Applications:	4,244
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARICEPT ODT
DailyMed Link:	ARICEPT ODT at DailyMed

Recent Clinical Trials for ARICEPT ODT

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 ODT clinical trials

Paragraph IV (Patent) Challenges for ARICEPT ODT

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

US Patents and Regulatory Information for ARICEPT ODT

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 ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004		DISCN	Yes	No
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004		DISCN	Yes	No

Expired US Patents for ARICEPT ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004

International Patents for ARICEPT ODT

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

Country	Patent Number	Title	Estimated Expiration
China	1073939
Japan	S6479151	CYCLIC AMINE DERIVATIVE
Hungary	T50768

Supplementary Protection Certificates for ARICEPT ODT

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

ARICEPT ODT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARICEPT ODT

Introduction to ARICEPT ODT

ARICEPT ODT, also known as donepezil, is a medication primarily used to manage the symptoms of Alzheimer's disease and other forms of dementia. It is classified as a cholinesterase inhibitor, which works by increasing levels of acetylcholine, a neurotransmitter crucial for memory and cognitive function[4].

Market Size and Growth

The global donepezil market, which includes ARICEPT ODT, was valued at $0.9 billion in 2023 and is projected to reach $1.1 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 1.9% from 2024 to 2033. This growth is driven by the increasing prevalence of Alzheimer’s disease, the rising geriatric population, and the growing demand for effective cognitive-enhancing treatments[4].

Regional Market Dynamics

North America holds a significant share of the donepezil market, largely due to the presence of leading biotechnology and pharmaceutical companies, advanced healthcare infrastructure, and significant investments in research and development. The U.S. in particular has a high adoption rate of genomic technologies, driven by government initiatives and growing demand for molecular diagnostics. The Asia-Pacific region is expected to exhibit the fastest growth rate during the forecast period, driven by increasing healthcare expenditure, growing awareness of personalized medicine, and an expanding biotechnology sector[4].

Competitive Landscape

The market for donepezil, including ARICEPT ODT, is competitive with several key players such as Intas Pharmaceuticals Ltd., Alkem, Eisai Co., Ltd., Dr. Reddy’s Laboratories Ltd., and others. The competition is further intensified by the availability of generic versions of donepezil. For instance, Sandoz launched generic donepezil HCL tablets and orally disintegrating tablets (ODT) in 2011, which are identical in dosing regimens to ARICEPT and ARICEPT ODT[5].

Financial Performance and Sales

Historically, ARICEPT and its generic versions have generated significant revenue. For example, US sales for donepezil HCL film-coated tablets and donepezil HCL ODT were approximately $2.3 billion for the 12 months ending March 2011[5].

In the broader Alzheimer's disease market, ARICEPT ODT is part of a segment that is expected to grow substantially. By 2026, the global Alzheimer's disease market is anticipated to reach $14.8 billion, with a CAGR of 17.5% from 2016 to 2026. This growth is largely driven by the introduction of disease-modifying therapies (DMTs) and the increasing prevalence of Alzheimer’s disease and mild cognitive impairment (MCI)[1].

Impact of Generic Versions

The launch of generic versions of donepezil has significantly impacted the market dynamics. Generic versions offer more affordable alternatives, which can reduce the market share of branded drugs like ARICEPT ODT. However, the branded version still maintains a strong presence due to its established reputation and patient loyalty. For instance, despite the availability of generics, Namzaric (a combination of donepezil and memantine) is expected to continue growing, with peak sales forecasted to be $574.1 million in 2025 before its patent expires[1].

Research and Development

The ongoing research and development in Alzheimer’s disease treatments are crucial for the future of ARICEPT ODT and similar medications. The lack of DMTs remains a significant unmet need, and many physicians believe that the first DMT for Alzheimer’s will be approved within the next 5 to 10 years. This anticipation drives continued investment in research, including collaborations such as the Dominantly Inherited Alzheimer’s Network Trials Unit (DIAN-TU), which aims to prevent the onset of Alzheimer’s disease[1].

Government and Public Health Initiatives

Government initiatives and public health programs play a vital role in the market dynamics of Alzheimer’s treatments. For example, the Alzheimer’s Drug Therapy Initiative (ADTI) in British Columbia was a partnership between the government and pharmaceutical companies to provide coverage for Alzheimer’s medications. Such initiatives help in making these medications more accessible to patients and can influence market growth[2].

Challenges and Limitations

Despite the growth prospects, the Alzheimer’s disease market, including ARICEPT ODT, faces several challenges. These include high research and development expenses, the unreliability and disruption of medical trials, and regulatory uncertainties. These factors can restrict the growth of the market and impact the financial trajectory of specific drugs[3].

Future Outlook

The future outlook for ARICEPT ODT and the broader Alzheimer’s disease market is promising but complex. With the increasing prevalence of Alzheimer’s disease and the introduction of new therapies, the market is expected to grow. However, the competition from generics, the need for innovative treatments, and the challenges in drug development will continue to shape the market dynamics.

Key Takeaways

• The global donepezil market, including ARICEPT ODT, is projected to grow at a CAGR of 1.9% from 2024 to 2033.
• North America and the Asia-Pacific region are key markets due to advanced healthcare infrastructure and growing demand.
• Generic versions of donepezil impact the market share of branded drugs but do not eliminate their presence.
• Research and development are critical for future growth, with a focus on disease-modifying therapies.
• Government initiatives and public health programs are essential for making Alzheimer’s treatments accessible.

Frequently Asked Questions

Q: What is the current market size of the donepezil market? A: The global donepezil market was valued at $0.9 billion in 2023[4].

Q: What is the projected growth rate of the donepezil market? A: The donepezil market is projected to grow at a CAGR of 1.9% from 2024 to 2033[4].

Q: Which regions are expected to drive the growth of the donepezil market? A: North America and the Asia-Pacific region are expected to drive the growth of the donepezil market[4].

Q: How do generic versions impact the market for ARICEPT ODT? A: Generic versions offer more affordable alternatives, reducing the market share of branded drugs but not eliminating their presence[5].

Q: What are the main challenges facing the Alzheimer’s disease market? A: High research and development expenses, unreliability and disruption of medical trials, and regulatory uncertainties are significant challenges[3].

Cited Sources

1. MARKET BRIEF - Alzheimer's Disease Market Report (2016-2026) - GlobalData
2. Manufacturer Comments – Clinical Evidence Review Report and Supplemental Update and Pharmacoeconomic Review Report - Pfizer Canada Inc.
3. Global Alzheimer's Drugs Market Report 2023 - 2027: Key Players Include Sanofi, F. Hoffmann-La Roche, Pfizer, and Abbott Laboratories - GlobeNewswire
4. Donepezil Market Size, Share, Trends & Growth Statistics, 2033 - Allied Market Research
5. Sandoz launches donepezil HCL tablets, a generic version of Aricept - FiercePharma