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Last Updated: December 22, 2024

DONEPEZIL HYDROCHLORIDE Drug Patent Profile


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Which patents cover Donepezil Hydrochloride, and when can generic versions of Donepezil Hydrochloride launch?

Donepezil Hydrochloride is a drug marketed by 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, and Zydus Pharms. and is included in forty-seven NDAs.

The generic ingredient in DONEPEZIL HYDROCHLORIDE 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 Donepezil Hydrochloride

A generic version of DONEPEZIL HYDROCHLORIDE was approved as donepezil hydrochloride by AUROBINDO on May 31st, 2011.

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Drug patent expirations by year for DONEPEZIL HYDROCHLORIDE
Recent Clinical Trials for DONEPEZIL HYDROCHLORIDE

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

SponsorPhase
Duke UniversityPhase 2
NeuroSense Therapeutics Ltd.Phase 2
FundaciĆ³ Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPhase 2

See all DONEPEZIL HYDROCHLORIDE clinical trials

Pharmacology for DONEPEZIL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DONEPEZIL HYDROCHLORIDE
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
Torrent Pharms DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090686-001 May 31, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203034-002 Jan 30, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202723-001 Jul 24, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202782-001 Oct 30, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202656-001 Oct 22, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Indicus Pharma DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201634-001 Jun 13, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201146-001 Aug 17, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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