Donepezil hydrochloride; memantine hydrochloride - Generic Drug Details

What are the generic drug sources for donepezil hydrochloride; memantine hydrochloride and what is the scope of freedom to operate?

Donepezil hydrochloride; memantine hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Ani Pharms, and Abbvie, and is included in three NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride; memantine hydrochloride has sixty-seven patent family members in nineteen countries.

Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for donepezil hydrochloride; memantine hydrochloride

International Patents:	67
US Patents:	12
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for donepezil hydrochloride; memantine hydrochloride
DailyMed Link:	donepezil hydrochloride; memantine hydrochloride at DailyMed

Recent Clinical Trials for donepezil hydrochloride; memantine hydrochloride

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

Sponsor	Phase
NeuroSense Therapeutics Ltd.	Phase 2
Peking Union Medical College Hospital	Phase 2
Tongji University	Phase 2

See all donepezil hydrochloride; memantine hydrochloride clinical trials

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL
		10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL
		10MG;14MG	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; memantine hydrochloride

Drug Class	Cholinesterase Inhibitor N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cholinesterase Inhibitors NMDA Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for donepezil hydrochloride; memantine hydrochloride

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

N06DX	Other anti-dementia drugs
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	7 mg/10 mg	206439	1	2016-09-26
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	21 mg/10 mg	206439	1	2016-09-23
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	14 mg/10 mg and 28 mg/10 mg	206439	1	2015-05-18

US Patents and Regulatory Information for donepezil hydrochloride; memantine 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					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014		RX	Yes	No			Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016		RX	Yes	No
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	AB	RX	Yes	No
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014		RX	Yes	No			Y

Expired US Patents for donepezil hydrochloride; memantine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014

EU/EMA Drug Approvals for donepezil hydrochloride; memantine hydrochloride

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
H. Lundbeck A/S	Acrescent	memantine hydrochloride, donepezil hydrochloride	EMEA/H/C/002424 Treatment of Alzheimers disease	Refused	no	no	no		2013-02-20
Merz Pharmaceuticals GmbH	Balaxur	memantine hydrochloride, donepezil hydrochloride	EMEA/H/C/002708	Refused	no	no	no		2013-02-20

International Patents for donepezil hydrochloride; memantine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2005215775	Combination of a NMDA receptor antagonist and an anti-depressive drug mao-inhibitor or a GADPH-inhibitor for the treatment of psychiatric conditions
World Intellectual Property Organization (WIPO)	2005079756
Poland	1874282
Singapore	157415	COMPOSITION COMPRISING A SUSTAINED RELEASE COATING OR MATRIX AND AN NMDA RECEPTOR ANTAGONIST, METHOD FOR ADMINISTRATION SUCH NMDA ANTAGONIST TO A SUBJECT
Australia	2005215767	Combination of an NMDA receptor antagonist and an anti-epileptic drug for the treatment of epilepsy and other CNS disorders

Supplementary Protection Certificates for donepezil hydrochloride; memantine 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; memantine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Donepezil Hydrochloride and Memantine Hydrochloride

Introduction to Donepezil Hydrochloride and Memantine Hydrochloride

Donepezil hydrochloride and memantine hydrochloride are two pivotal drugs in the treatment of Alzheimer's disease, a condition that is increasingly prevalent as the global population ages. Here, we delve into the market dynamics and financial trajectories of these medications.

Market Size and Growth Projections

Donepezil Hydrochloride Market

The global donepezil hydrochloride market has been experiencing significant growth. 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 from 2024 to 2030[4].

Memantine Hydrochloride Market

The memantine hydrochloride market is also on an upward trajectory. In 2023, the global memantine hydrochloride tablets market was valued at $0.62 billion and is expected to reach $1.1 billion by 2032, with a CAGR of 5.9% during the forecast period[5].

Market Segmentation

Donepezil Hydrochloride

The donepezil hydrochloride market is segmented based on type (5 mg/tablet, 10 mg/tablet, 23 mg/tablet) and application (hospitals, clinics, drugstores). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa are also key segments[1][4].

Memantine Hydrochloride

The memantine hydrochloride market is segmented by type (purity ≥98%, purity ≥99%, pill, capsule, oral liquid) and application (hospitals, laboratories, others). Similar to donepezil, the market is also analyzed across various geographical regions[2][5].

Drivers of Market Growth

Increasing Prevalence of Alzheimer's Disease

The rising incidence of Alzheimer's disease, driven by the aging global population, is a significant driver for both markets. As more people are diagnosed with Alzheimer's, the demand for these medications increases[4][5].

Technological and Scientific Advancements

Advancements in medical science and technology have improved the effectiveness and attractiveness of these drugs. Better understanding of the underlying mechanisms of Alzheimer's disease has led to more successful treatment plans, boosting market growth[4].

Regulatory Support and Reimbursement Policies

Stringent regulatory frameworks ensuring drug safety and quality, along with favorable reimbursement policies, have enhanced patient and healthcare provider trust in these medications. Government initiatives and advantageous reimbursement rules further facilitate access to these treatments[4].

Strategic Marketing and R&D

Pharmaceutical companies' strategic marketing initiatives and significant R&D expenditures have driven innovation, leading to the development of new dosage forms and formulations. This has expanded the market for both donepezil and memantine hydrochloride, improving patient outcomes[4].

Market Challenges

High Failure Rate in AD Drug Development

The Alzheimer's disease market is known for its high failure rate in drug development, with a failure rate of 99%. This makes it a challenging and risky market for pharmaceutical companies, despite its potential[3].

Generic Competition

The launch of generic versions of these drugs can significantly impact the market. For example, the sales of Namzaric (a combination of donepezil and memantine) are expected to drop once its patent expires and generic versions become available[3].

Key Players

Donepezil Hydrochloride Market

Key players in the donepezil hydrochloride market include Eisai, Pfizer, Teva, Novartis, Apotex, Dr. Reddy's Laboratories, Sun Pharmaceutical, Hansoh Pharma, Cipla, ARK PHA.LTD, Jishengtang Pharma, and Luoxin[4].

Memantine Hydrochloride Market

Prominent companies in the memantine hydrochloride market are similar, with a focus on pharmaceutical giants that specialize in neurological treatments. These include companies like Eisai, Pfizer, and other generic drug manufacturers[2].

Financial Outlook

Revenue Forecast

• Donepezil Hydrochloride: Expected to grow from $1.241 billion in 2023 to $1.8225 billion by 2030[4].
• Memantine Hydrochloride: Projected to grow from $0.62 billion in 2023 to $1.1 billion by 2032[5].

Sales Performance

The sales of combination drugs like Namzaric, which includes both donepezil and memantine, have been steadily increasing since its launch in 2016. Peak sales for Namzaric are forecasted to be $574.1 million in 2025, with overall sales in the Alzheimer's disease market expected to grow at a CAGR of 26.3% during the forecast period[3].

Market Dynamics Analysis

Porter's 5 Forces Framework

The market dynamics for both donepezil and memantine hydrochloride can be analyzed using Porter's 5 Forces Framework. This includes the bargaining power of suppliers, the bargaining power of buyers, the threat of new entrants, the threat of substitute products, and the competitive rivalry among existing competitors. The analysis highlights the competitive landscape and the potential for new entrants, which is somewhat limited due to the high regulatory barriers and the need for significant R&D investments[2].

Value Chain Analysis

A detailed value chain analysis reveals the critical stages from drug development to distribution. This includes the impact of raw material suppliers, manufacturing processes, distribution channels, and end-users. The value chain is influenced by factors such as regulatory approvals, pricing strategies, and the role of intermediaries like pharmacies and hospitals[2].

Conclusion

The markets for donepezil hydrochloride and memantine hydrochloride are poised for significant growth driven by the increasing prevalence of Alzheimer's disease, technological advancements, and supportive regulatory environments. Despite challenges such as high drug development failure rates and generic competition, these markets offer substantial opportunities for pharmaceutical companies.

Key Takeaways

• Growing Demand: Increasing incidence of Alzheimer's disease drives demand for donepezil and memantine hydrochloride.
• Technological Advancements: Improved understanding and treatment plans for Alzheimer's disease boost market growth.
• Regulatory Support: Stringent regulations and favorable reimbursement policies enhance market trust and access.
• Competitive Landscape: Key players invest heavily in R&D and marketing, expanding market reach.
• Financial Outlook: Both markets are expected to grow significantly, with donepezil reaching $1.8225 billion by 2030 and memantine reaching $1.1 billion by 2032.

FAQs

Q: What is the projected market size for donepezil hydrochloride by 2030?

A: The donepezil hydrochloride market is expected to reach $1.8225 billion by 2030[4].

Q: What is the CAGR for the memantine hydrochloride market from 2023 to 2032?

A: The memantine hydrochloride market is expected to exhibit a CAGR of 5.9% from 2023 to 2032[5].

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

A: The main drivers include the rising incidence of Alzheimer's disease, technological and scientific advancements, and supportive regulatory and reimbursement policies[4].

Q: Which companies are key players in the donepezil hydrochloride market?

A: Key players include Eisai, Pfizer, Teva, Novartis, Apotex, and others[4].

Q: How does the launch of generic versions impact the market for these drugs?

A: The launch of generic versions can significantly reduce the sales of branded drugs, as seen with the expected drop in Namzaric sales after its patent expires[3].

Sources

1. Market Research Intellect, "Global Donepezil Hydrochloride Market Size, Scope And Forecast Report".
2. Market Research Intellect, "Global Memantine HCl Market Size, Scope And Forecast Report".
3. Drug Development, "MARKET BRIEF - Alzheimer's Disease Market Report (2016-2026)".
4. Valuates Reports, "Donepezil Drug Market Research Report, Industry Forecast Analysis".
5. Business Research Insights, "Memantine Hydrochloride Tablets Market Trends, Forecast, 2032".