NAMENDA Drug Patent Profile

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

Namenda is a drug marketed by Allergan and Abbvie and is included in three NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in NAMENDA is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Namenda

A generic version of NAMENDA was approved as memantine hydrochloride by DR REDDYS LABS LTD on April 14^th, 2010.

Summary for NAMENDA

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	76
Patent Applications:	2,697
Drug Prices:	Drug price information for NAMENDA
What excipients (inactive ingredients) are in NAMENDA?	NAMENDA excipients list
DailyMed Link:	NAMENDA at DailyMed

See drug prices for NAMENDA

See drug sales revenues for NAMENDA

Recent Clinical Trials for NAMENDA

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

Sponsor	Phase
University of Chicago	Phase 2/Phase 3
Children's Hospital Medical Center, Cincinnati	Early Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1

See all NAMENDA clinical trials

Pharmacology for NAMENDA

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

Paragraph IV (Patent) Challenges for NAMENDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAMENDA	Tablets	memantine hydrochloride	5 mg and 10 mg	021487	14	2007-10-16

US Patents and Regulatory Information for NAMENDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	NAMENDA	memantine hydrochloride	SOLUTION;ORAL	021627-001	Apr 18, 2005		DISCN	Yes	No
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010		DISCN	Yes	No	8,039,009*PED				Y
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010		DISCN	Yes	No	8,039,009*PED				Y
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-001	Oct 16, 2003	AB	RX	Yes	No

Expired US Patents for NAMENDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	5,061,703*PED
Allergan	NAMENDA	memantine hydrochloride	SOLUTION;ORAL	021627-001	Apr 18, 2005	5,061,703*PED
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	5,614,560
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-001	Oct 16, 2003	5,614,560

EU/EMA Drug Approvals for NAMENDA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merz Pharmaceuticals GmbH	Memantine Merz	memantine hydrochloride	EMEA/H/C/002711 Treatment of patients with moderate to severe Alzheimer’s disease.	Authorised	no	no	no	2012-11-22

International Patents for NAMENDA

See the table below for patents covering NAMENDA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	215592	Eljárás adamantánszármazékokat tartalmazó agyi ischemia megelőzésére és kezelésére alkalmas gyógyászati készítmények előállítására (PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITION CONTAINING ADAMANTANE DERIVATIVES FOR TREATING AND PROFILACTING CEREBRAL ISCHEMIA)
Japan	H04504260
Spain	2264122
Japan	2006117693	METHOD OF PREVENTING N-METHYL-D-ASPARTATE (NMDA) RECEPTOR COMPLEX-MEDIATED NEURONAL DAMAGE

Supplementary Protection Certificates for NAMENDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0392059	90988	Luxembourg
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059	SPC/GB02/046	United Kingdom		PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515

NAMENDA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NAMENDA

Overview of NAMENDA

NAMENDA, also known as memantine, is a prescription medication used to treat moderate to severe dementia caused by Alzheimer's disease. It is an N-Methyl-D-aspartate (NMDA) receptor antagonist that works by inhibiting the function of glutamate, a natural molecule in the brain associated with Alzheimer's disease symptoms[4].

Market Size and Growth

The global Alzheimer's drugs market, which includes memantine, was valued at US$ 7 billion in 2016. This market is projected to exhibit a Compound Annual Growth Rate (CAGR) of 9.5% over the forecast period from 2017 to 2025[3].

Specific Growth Projections for Memantine

The memantine market itself is expected to grow at a CAGR of 7.20% from 2022 to 2029. This growth is driven by increasing demand for treatments for Alzheimer's disease and other forms of dementia[4].

Key Market Drivers

Increasing Prevalence of Alzheimer's Disease

The growing prevalence of Alzheimer's disease and mild cognitive impairment (MCI) is a significant driver for the memantine market. As the global population ages, the incidence of these conditions is expected to rise, leading to higher demand for therapeutic options like memantine[1].

Advancements in Treatment Options

The development and launch of new disease-modifying therapies, including monoclonal antibody-based immunotherapies and BACE inhibitors, are expected to drive market growth. However, memantine remains a staple in the treatment of moderate to severe Alzheimer's disease due to its established efficacy and safety profile[1].

Distribution Channels

The distribution of memantine through various channels such as hospital pharmacies, retail pharmacies, and online pharmacies contributes to its market growth. The convenience and accessibility of these channels help in increasing the reach and adoption of the drug[3][4].

Financial Performance of NAMENDA

Historical Sales Data

NAMENDA's net revenues have seen significant fluctuations. For example, in the fourth quarter of 2018, NAMENDA's net revenues were $10.7 million, down from $97.8 million in the prior year quarter, largely due to the loss of patent exclusivity and the subsequent introduction of generic versions[2].

Current and Projected Sales

Despite the decline in sales due to generic competition, memantine still maintains a significant market presence. The sales of memantine are expected to continue, albeit at a lower level than during its peak. For instance, Namzaric (a combination of donepezil and memantine), another product in the Alzheimer's treatment space, is expected to see peak sales of $574.1 million in 2025 before declining due to patent expiration[1].

Financial Metrics of Allergan (Manufacturer)

Quarterly and Annual Financials

Allergan, the manufacturer of NAMENDA, reported mixed financial results in recent years. For example, in the fourth quarter of 2019, Allergan's non-GAAP operating income was $2.08 billion, an increase of 8.4% compared to the prior year quarter. However, the company also reported a GAAP operating loss of $276.6 million in the same period[5].

Revenue and Expense Breakdown

Allergan's total net revenues for 2019 were $16,088.9 million, a 1.9% increase from the previous year. The company's non-GAAP adjusted EBITDA was $7,760.1 million, a 2.4% decrease from the previous year. These financial metrics indicate the overall health and stability of the company, despite fluctuations in specific product sales[5].

Competitive Landscape

The memantine market is competitive, with several key players including Merz Pharmaceuticals, Lupin Limited, Allergan plc, Novartis AG, and others. The competitive landscape is influenced by the presence of generic versions of memantine, which has impacted the sales of branded products like NAMENDA[3][4].

Regulatory and Patent Considerations

The expiration of patents for memantine has led to the introduction of generic versions, significantly impacting the sales of branded NAMENDA. This shift has forced manufacturers to adapt their strategies to maintain market share and revenue[2].

Future Outlook

Market Trends and Developments

The future outlook for memantine is influenced by emerging trends in Alzheimer's disease treatment, including the development of new therapies and the increasing focus on early-stage treatments. Despite the competition from generics, memantine is expected to remain a viable treatment option due to its established efficacy and patient compliance[1][3].

Challenges and Opportunities

The main challenge for NAMENDA and other Alzheimer's treatments is the rapid evolution of the therapeutic landscape. New disease-modifying therapies are being developed, which could potentially shift market dynamics. However, the ongoing need for effective treatments for Alzheimer's disease presents opportunities for memantine to continue playing a significant role in patient care[1].

Key Takeaways

• Market Growth: The memantine market is expected to grow at a CAGR of 7.20% from 2022 to 2029.
• Drivers: Increasing prevalence of Alzheimer's disease, advancements in treatment options, and diverse distribution channels drive market growth.
• Financial Performance: NAMENDA's sales have declined due to generic competition, but it remains a significant player in the Alzheimer's treatment market.
• Competitive Landscape: The market is competitive with several key players and the presence of generic versions.
• Future Outlook: Emerging trends and the development of new therapies will shape the future of memantine in the Alzheimer's treatment market.

FAQs

What is NAMENDA used for?

NAMENDA, or memantine, is used to treat moderate to severe dementia caused by Alzheimer's disease. It works by inhibiting the function of glutamate in the brain[4].

How is the memantine market expected to grow?

The memantine market is expected to grow at a CAGR of 7.20% from 2022 to 2029, driven by increasing demand for Alzheimer's disease treatments[4].

What are the key drivers of the memantine market?

Key drivers include the growing prevalence of Alzheimer's disease, advancements in treatment options, and the availability of the drug through various distribution channels[1][3].

How has the sales performance of NAMENDA been affected by generic competition?

The sales of NAMENDA have declined significantly due to the loss of patent exclusivity and the introduction of generic versions[2].

What is the competitive landscape of the memantine market?

The market is competitive with several key players, including Merz Pharmaceuticals, Lupin Limited, and Allergan plc, and is influenced by the presence of generic versions[3][4].

Sources

1. GlobalData, "MARKET BRIEF - Alzheimer's Disease Market Report (2016-2026)", Drug Development.
2. Allergan, "Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results", News AbbVie.
3. OpenPR, "Memantine Market advancements Highlighted by Demand, Business Growing Strategies and Forecast 2031", OpenPR.
4. Data Bridge Market Research, "Global Memantine Market - Industry Trends and Forecast to 2029", Data Bridge Market Research.
5. Allergan, "Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results", PR Newswire.