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, Endo Operations, Esjay Pharma, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Osmotica Pharm Us, 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 Pharms, Ani Pharms, and Abbvie, and is included in fifty-five NDAs. There are twenty-two 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-five patent family members in sixteen countries.

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

Summary for donepezil hydrochloride

International Patents:	125
US Patents:	22
Tradenames:	6
Applicants:	44
NDAs:	55
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	320
Patent Applications:	6,406
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
Duke University	Phase 2
NeuroSense Therapeutics Ltd.	Phase 2
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Phase 2

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
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014		RX	Yes	No	8,039,009*PED				Y
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		RX	Yes	Yes	10,835,499		Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes	8,058,291

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	6,245,911
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010	4,895,841
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	6,140,321

International Patents for donepezil hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	3032103	SYSTEMES D'ADMINISTRATION TRANSDERMIQUE DE MEMANTINE (MEMANTINE TRANSDERMAL DELIVERY SYSTEMS)
Japan	4999466
Canada	3010183	SYSTEMES ET PROCEDES D'ADMINISTRATION TRANSDERMIQUE A LONG TERME (SYSTEMS AND METHODS FOR LONG TERM TRANSDERMAL ADMINISTRATION)

Supplementary Protection Certificates for donepezil hydrochloride

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

Donepezil hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Donepezil Hydrochloride

Introduction to Donepezil Hydrochloride

Donepezil hydrochloride, commonly known by the brand name Aricept, is a medication prescribed for the treatment of Alzheimer's disease. It belongs to the class of cholinesterase inhibitors, which work by increasing the levels of a neurotransmitter called acetylcholine in the brain, thereby improving cognitive function.

Market Growth and Projections

The donepezil hydrochloride market has experienced significant growth in recent years and is expected to continue this upward trend. Here are some key points regarding its market dynamics and projections:

Rapid Expansion

The donepezil hydrochloride market has shown a swift and substantial surge, with forecasts indicating continued significant expansion from 2023 to 2031. This positive momentum suggests robust growth rates throughout the forecasted period[1][4].

Market Size and Revenue

The market size of the donepezil hydrochloride tablet market is anticipated to grow substantially, with the market reaching a significant value in USD billion by the end of 2031. This growth is driven by various factors, including the increasing prevalence of Alzheimer's disease and the rising demand for effective treatments[4].

Drivers of Market Growth

Several factors are driving the growth of the donepezil hydrochloride market:

Increasing Prevalence of Alzheimer's Disease

The rise in cases of Alzheimer's disease, particularly among the elderly population, is a major driver. As the global population ages, the demand for Alzheimer's treatments is expected to increase, contributing to the market's growth[3].

Government Spending on Healthcare

Increased government spending on healthcare, especially for research and development activities, is another significant factor. This investment in healthcare infrastructure and R&D activities boosts the development and approval of new drugs, including those for Alzheimer's disease[3].

Economic Benefits

Studies have shown that while the cost of donepezil includes higher expenditures for prescription drugs, it can be offset by a slower rate of institutionalization. For instance, patients receiving donepezil had a lower rate of institutionalization compared to those not receiving the drug, which can lead to overall cost savings in the long term[2].

Challenges and Restraints

Despite the positive growth trajectory, there are several challenges and restraints affecting the market:

High R&D Expenses

The high costs associated with research and development activities for Alzheimer's drugs can be a significant restraint. These expenses can be prohibitive for some pharmaceutical companies, limiting the number of new drugs in development[3].

Clinical Trial Disruptions

The non-performance, unreliability, and disruption of medical trials for Alzheimer's medicines also pose challenges. These issues can delay the approval and launch of new treatments, impacting market growth[3].

Financial Aspects of Donepezil Hydrochloride

The financial aspects of donepezil hydrochloride are multifaceted and influenced by several factors:

Cost of the Drug

The cost of donepezil hydrochloride can vary based on several factors, including the patient's treatment plan, insurance coverage, and the pharmacy used. Without insurance, the cost is typically higher, but savings programs and generic versions can reduce expenses[5].

Generic vs. Brand-Name

Generic versions of donepezil hydrochloride are generally cheaper than the brand-name version, Aricept. This is because generic drugs do not require the same costly testing as brand-name drugs and benefit from marketplace competition once the patent expires[5].

Insurance Coverage

Insurance coverage plays a crucial role in determining the cost of donepezil hydrochloride. Different insurance plans, including Medicare, may cover the drug differently, and prior authorization may be required in some cases[5].

Market Segmentation

The donepezil hydrochloride market is segmented based on several criteria:

Type

The market is segmented by the type of tablet, typically 5 mg and 10 mg per tablet. This segmentation helps in understanding the demand for different dosages and their respective market shares[4].

Application

The market is also segmented by application, including hospitals, drugstores, and other healthcare facilities. This segmentation provides insights into where the drug is most commonly prescribed and used[4].

Geographical Regions

The market is analyzed across various geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. This helps in identifying regional trends and growth opportunities[4].

Economic Evaluation

An economic evaluation of donepezil hydrochloride highlights its cost-effectiveness:

"Mean 6-month direct medical expenses for a patient receiving donepezil were $3443, including the cost of the drug, whereas the per-patient mean expenses for the comparison group were $3476. Although the patients receiving donepezil had greater expenditures for prescription drugs, these costs were offset by a slower rate of institutionalization."[2]

This evaluation underscores the potential long-term cost savings associated with donepezil treatment.

Key Players and Market Competition

The Alzheimer's drugs market, including donepezil hydrochloride, is competitive with several key players involved:

Major Pharmaceutical Companies

Companies like Sanofi, F. Hoffmann-La Roche, Pfizer, and Abbott Laboratories are significant players in the Alzheimer's drugs market. These companies invest heavily in R&D and marketing, which influences market dynamics[3].

Future Outlook

The future outlook for the donepezil hydrochloride market is promising, driven by the increasing demand for Alzheimer's treatments and advancements in healthcare:

Rising Demand

The growing elderly population and the increasing prevalence of Alzheimer's disease will continue to drive the demand for donepezil hydrochloride and other Alzheimer's treatments[3].

Technological Advancements

Advancements in medical technology and ongoing research are expected to improve the efficacy and safety of donepezil hydrochloride, further boosting its market growth[1].

Conclusion

The donepezil hydrochloride market is poised for significant growth, driven by the increasing prevalence of Alzheimer's disease, government spending on healthcare, and the economic benefits associated with the drug. While challenges such as high R&D expenses and clinical trial disruptions exist, the overall trajectory indicates robust growth rates in the foreseeable future.

Key Takeaways

• Market Growth: The donepezil hydrochloride market is expected to experience significant growth from 2023 to 2031.
• Drivers: Increasing prevalence of Alzheimer's disease, government spending on healthcare, and economic benefits of the drug.
• Challenges: High R&D expenses, clinical trial disruptions, and insurance coverage complexities.
• Financial Aspects: Cost varies based on insurance, pharmacy, and generic vs. brand-name options.
• Market Segmentation: Segmented by type, application, and geographical regions.
• Economic Evaluation: Donepezil hydrochloride is cost-effective due to reduced institutionalization rates.

FAQs

Q: What is the primary use of donepezil hydrochloride?

A: Donepezil hydrochloride is primarily used for the treatment of Alzheimer's disease.

Q: How does the cost of donepezil hydrochloride vary?

A: The cost of donepezil hydrochloride varies based on factors such as insurance coverage, the pharmacy used, and whether a generic or brand-name version is prescribed.

Q: What are the key drivers of the donepezil hydrochloride market?

A: Key drivers include the increasing prevalence of Alzheimer's disease, government spending on healthcare, and the economic benefits associated with the drug.

Q: What challenges does the donepezil hydrochloride market face?

A: Challenges include high R&D expenses, clinical trial disruptions, and complexities in insurance coverage.

Q: How does donepezil hydrochloride impact medical expenses?

A: Donepezil hydrochloride can lead to higher prescription drug costs but is offset by a slower rate of institutionalization, resulting in overall cost savings.

Sources

1. Market Research Intellect: Donepezil Hydrochloride Market Size, Scope And Forecast Report.
2. PubMed: An economic evaluation of donepezil in the treatment of Alzheimer's disease.
3. GlobeNewswire: Global Alzheimer's Drugs Market Report 2023 - 2027.
4. Market Research Intellect: Donepezil Hydrochloride Tablet Market Size, Scope And Forecast Report.
5. Medical News Today: Cost and Aricept: Financial assistance options, savings, more.