MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Drug Patent Profile

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

Memantine Hydrochloride And Donepezil Hydrochloride is a drug marketed by Amneal Pharms and Ani Pharms and is included in two NDAs.

The generic ingredient in MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

Summary for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	26
DailyMed Link:	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MEMANTINE HYDROCHLORIDE AND DONEPEZIL 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 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE clinical trials

Pharmacology for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

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

US Patents and Regulatory Information for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208328-001	Jan 27, 2017		DISCN	No	No
Amneal Pharms	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208328-002	Jan 27, 2017		DISCN	No	No
Ani Pharms	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208237-001	Dec 15, 2023	AB	RX	No	No

EU/EMA Drug Approvals for MEMANTINE HYDROCHLORIDE AND DONEPEZIL 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

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Memantine Hydrochloride and Donepezil Hydrochloride

Introduction to Memantine Hydrochloride and Donepezil Hydrochloride

Memantine hydrochloride and donepezil hydrochloride are two widely used medications in the treatment of Alzheimer's disease. When combined, they form the drug NAMZARIC, which has been a significant player in the Alzheimer’s disease market since its launch in 2015.

Market Launch and Initial Performance

NAMZARIC, the combination drug of memantine hydrochloride and donepezil hydrochloride, was introduced to the US market in May 2015. Despite lacking significant differentiation from generic versions of its constituent drugs, NAMZARIC achieved substantial revenue. In its first year, the drug generated around $90 million in sales, which steadily increased to over $200 million annually by 2017[3].

Sales Growth and Revenue

The sales of NAMZARIC have shown a consistent growth pattern. From 2015 to 2020, the drug's annual sales ranged from $90 million to $267 million. This growth is notable, especially considering that the drug has not been actively promoted since 2018. By 2020, NAMZARIC's yearly sales had stabilized around $200-250 million[3].

Market Share and Competition

NAMZARIC operates in a highly competitive Alzheimer’s disease market, facing competition from both branded and generic versions of memantine and donepezil. However, it has managed to capture a significant market share due to its convenience as a single-dose capsule. Many physicians still prescribe the generic versions of these drugs separately, but the combined formulation of NAMZARIC offers a convenient alternative[1][3].

Financial Projections

Financial projections indicate that NAMZARIC's sales will continue to grow, albeit at a slower rate. Peak sales of NAMZARIC are forecast to reach $574.1 million by 2025. After this peak, sales are expected to decline due to the expiration of its patent and the subsequent availability of generic versions[1][3].

Cost-Effectiveness and Clinical Outcomes

Studies have shown that the combination of memantine and donepezil is cost-effective and improves clinical outcomes. A phase III trial demonstrated that patients with moderate-to-severe Alzheimer's disease receiving memantine in addition to donepezil had improved cognitive function and reduced total costs of care. The cost-effectiveness analysis indicated that while pharmacotherapy costs increased by $1250 during the year of memantine treatment, costs of formal and informal services decreased by $1240 over the same period[2].

Broader Market Trends

The Alzheimer’s disease market is poised for significant growth driven by innovative therapies. Monoclonal antibody-based immunotherapies and BACE inhibitors are expected to dominate the market, with drugs like aducanumab leading the charge. Despite the high failure rate of Alzheimer’s disease drugs, the pipeline is large and consists of many novel mechanisms, making it an exciting and rapidly changing market[1].

Impact of Aging Population and Public Awareness

The global aging population and growing public awareness of Alzheimer’s disease are key drivers of the market. The prevalence of Alzheimer’s disease is projected to rise sharply, with the number of affected individuals in the US expected to increase from 6.7 million in 2023 to 14 million by 2060. This demographic shift and the increasing demand for effective treatments drive pharmaceutical manufacturers to invest in Alzheimer’s disease research and development[4].

Regional Market Dynamics

The market for donepezil, a component of NAMZARIC, varies by region. North America has a significant market share due to advanced healthcare infrastructure and significant investment in research and development. The Asia-Pacific region is expected to exhibit the fastest growth rate, driven by increasing healthcare expenditure, growing awareness of personalized medicine, and an expanding biotechnology sector[4].

Competitive Landscape

NAMZARIC faces competition from generic versions of memantine and donepezil, as well as from other branded Alzheimer’s disease treatments. However, its convenience and the established efficacy of its constituent drugs have helped it maintain a strong market position. The broader competitive landscape is evolving with the introduction of novel disease-modifying therapies, which are expected to reshape the market in the coming years[1][3].

Future Outlook

The future outlook for NAMZARIC is mixed. While it is expected to continue generating revenue, its sales will likely decline post-2025 due to patent expiration. The broader Alzheimer’s disease market, however, is poised for significant growth driven by innovative therapies. Pharmaceutical companies are investing heavily in research and development to find the first disease-modifying drug for Alzheimer’s, which could significantly alter the market dynamics[1][3].

Key Takeaways

• Steady Sales Growth: NAMZARIC has shown consistent sales growth since its launch in 2015.
• Peak Sales Forecast: Peak sales are expected to reach $574.1 million by 2025.
• Decline Post-Patent Expiration: Sales are anticipated to decline after 2025 due to patent expiration.
• Market Competition: Faces competition from generic versions of memantine and donepezil.
• Broader Market Trends: The Alzheimer’s disease market is growing rapidly due to the introduction of novel disease-modifying therapies.
• Cost-Effectiveness: The combination of memantine and donepezil is cost-effective and improves clinical outcomes.

FAQs

What is NAMZARIC and how does it treat Alzheimer’s disease?

NAMZARIC is a combination drug of memantine hydrochloride and donepezil hydrochloride, used to treat moderate-to-severe Alzheimer’s disease. It combines two commonly prescribed drugs into a single capsule for convenience.

How has NAMZARIC performed in terms of sales since its launch?

NAMZARIC has shown steady sales growth since its launch in 2015, reaching annual sales of over $200 million by 2017 and stabilizing around $200-250 million by 2020.

What are the financial projections for NAMZARIC?

Peak sales of NAMZARIC are forecast to reach $574.1 million by 2025, after which sales are expected to decline due to patent expiration.

How does NAMZARIC fit into the broader Alzheimer’s disease market?

NAMZARIC operates in a competitive market but has managed to capture a significant share. However, the broader market is driven by the development of novel disease-modifying therapies.

What are the key drivers of the Alzheimer’s disease market?

The global aging population, growing public awareness, and advancing diagnostic capabilities are key drivers of the Alzheimer’s disease market.

Sources

1. MARKET BRIEF - Alzheimer's Disease Market Report (2016-2026) - Drug Development.
2. Cost-effectiveness of memantine in moderate-to-severe Alzheimer's ... - PubMed.
3. NAMZARIC Drug Patent Profile - DrugPatentWatch.
4. Donepezil Market Size, Share, Trends & Growth Statistics, 2033 - Allied Market Research.