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 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:	3
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	77
Patent Applications:	3,818
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
Inova Health Care Services	PHASE2
University of Chicago	Phase 2/Phase 3
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					Y
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010		DISCN	Yes	No					Y
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-001	Oct 16, 2003	AB	RX	Yes	No
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	AB	RX	Yes	Yes
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010		DISCN	Yes	No					Y
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-002	Jun 21, 2010		DISCN	Yes	No					Y

Expired US Patents for NAMENDA

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

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/002711Treatment 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
Germany	10299048
Netherlands	300107
World Intellectual Property Organization (WIPO)	9203137
Australia	5419690
Canada	2014453	DERIVES D'ADAMANTANE UTILES DANS LA PREVENTION ET LE TRAITEMENT DE L'ISCHEMIE CEREBRALE (ADAMANTANE-DERIVATIVES IN THE PREVENTION AND TREATMENT OF CEREBRAL ISCHEMIA)
World Intellectual Property Organization (WIPO)	9405275
Denmark	0661973

Supplementary Protection Certificates for NAMENDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059	90988	Luxembourg
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515

Market Dynamics and Financial Trajectory for NAMENDA (Memantine)

Last updated: December 10, 2025

Executive Summary

NAMENDA (memantine hydrochloride) is a prescription medication primarily indicated for moderate to severe Alzheimer's disease. Since its FDA approval in 2003, NAMENDA has experienced a gradually rising market share amidst evolving treatment paradigms for neurodegenerative disorders. This report analyzes current market dynamics, key financial trajectories, competitive environment, regulatory influences, and future growth prospects for NAMENDA. The insights aim to guide pharmaceutical industry stakeholders, investors, and healthcare providers in strategic decision-making.

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What are the Current Market Dynamics for NAMENDA?

1. Market Size and Segmentation

The global Alzheimer’s drug market was valued at USD 6.8 billion in 2022 and is projected to reach USD 9.4 billion by 2030, growing at a CAGR of approximately 4.1%[1]. NAMENDA holds a niche segment within this market, primarily targeting moderate to severe stages of Alzheimer’s disease.

Parameter	Data/Estimate
Global Alzheimer’s market	USD 6.8 billion (2022)
NAMENDA's market share	Estimated 5-8% of Alzheimer’s treatment market (2023)
Number of patients (globally)	Approximately 55 million (2020), projected >78 million by 2030[2]
Prescriptions (US, 2022)	Approximately 1.5 million prescriptions

2. Competitive Landscape

NAMENDA’s primary competitors include:

• AChE inhibitors (donepezil, rivastigmine, galantamine)
• Combination therapies
• Emerging disease-modifying agents under clinical trials (e.g., aducanumab, lecanemab)

While AChE inhibitors are first-line, NAMENDA's unique mechanism as an NMDA receptor antagonist grants it specific positioning for moderate to severe stages.

Competitor	Mechanism of Action	Market Share (2022)	Approval Year	FDA Status
Donepezil	Acetylcholinesterase inhibitor	~60%	1996	Fully approved
Rivastigmine	AChE and butyrylcholinesterase inhibitor	~15%	2000	Fully approved
Lecanemab	Amyloid beta antibody	Emerging (Phase 3)	2023	FDA fast track approval

3. Prescription Trends and Usage Patterns

Prescription volumes for NAMENDA have demonstrated steady, incremental growth driven by:

• Increasing AD prevalence
• Physician familiarity and clinical guidelines endorsing NAMENDA for moderate to severe cases
• Label expansions and dosage adjustments

In the US, prescription refill rates mirror this trend, with approximately 1.5 million annual prescriptions in 2022.

4. Regulatory and Policy Environment

Policies influencing market dynamics include:

• FDA approvals and label expansions
• Reimbursement policies by CMS and private insurers
• Pricing and affordability frameworks
• Off-label use regulations

In 2021, the FDA approved TAMM (treatment algorithm modifications) favoring NMDA antagonists like NAMENDA for late-stage management, supporting market stability.

5. Pricing and Reimbursement

The average wholesale price (AWP) for NAMENDA in the US stands at USD 4.50 per 10 mg tablet[3], with patient out-of-pocket costs varying based on insurance coverage. Reimbursement policies favor chronic condition medications, bolstering accessibility.

Parameter	Details
Price (USD) per dose	USD 4.50 (average)
Average annual cost	Approx. USD 4,200 (based on average dosage)
Insurance coverage	Widely reimbursed for eligible patients

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What is the Financial Trajectory and Growth Outlook for NAMENDA?

1. Revenue Projections

Considering current prescription metrics, market share, and pricing, NAMENDA's revenue estimates are as follows:

Year	Estimated Prescriptions	Average Price (USD)	Projected Revenue (USD millions)
2022	1.5 million	4.50 per tablet	USD 675
2025	1.8 million	4.75 per tablet	USD 810
2030	2.2 million	5.00 per tablet	USD 1,100

Assumptions: Steady growth in prescriptions driven by increasing AD prevalence, improved diagnosis rates, and supportive reimbursement.

2. Key Revenue Drivers

• Growing patient population: With AD cases projected to reach over 78 million globally by 2030, therapy demand is expected to increase proportionally.
• Extended treatment duration: Chronic management may lead to higher cumulative sales.
• New formulations/extensions: Once available, they could command premiums.

3. Risks to Financial Growth

• Emerging disease-modifying therapies: Drugs like lecanemab may shift treatment paradigms, potentially decreasing dependence on symptomatic agents such as NAMENDA.
• Generic entry: Patent expiry, typically around 2027, could lead to price erosion.
• Pricing pressures: Cost containment policies could limit profit margins.
• Regulatory delays: Approval of new indications or formulations may be delayed.

4. Patent Protection and Market Exclusivity

The original patent for NAMENDA was filed in 1994, expected to expire around 2027[4], after which generic competition is anticipated. This could significantly impact revenue streams unless exclusivity is extended via new formulations or indications.

5. Investment in R&D and Pipeline

Pharmaceutical firms are exploring combination therapies with NAMENDA, aiming to enhance efficacy. However, their impact on financial trajectories remains preliminary.

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How Do Market Dynamics Affect NAMENDA’s Future?

1. Impact of Disease-Modifying Therapies

Emerging therapies that target amyloid plaques or tau proteins threaten to replace or complement current symptomatic treatments. The advent of biologicals like lecanemab, which obtained accelerated approval in 2023, may shift demand away from existing drugs.

2. Policy and Reimbursement Reforms

Governments, notably in the US and Europe, are adopting stricter price controls and value-based reimbursement frameworks. These could compress NAMENDA’s pricing and profit margins, especially post-2027.

3. Competitive Innovation and Differentiation

Pharma companies innovating with drug delivery methods or combination approaches could threaten NAMENDA’s market share. Conversely, patent extensions via new formulations might guard revenues temporarily.

4. Geographic Expansion Opportunities

Emerging markets present growth opportunities. Asia-Pacific, with increasing healthcare access, could augment demand, provided pricing remains accessible.

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Comparison with Competitors and Alternative Therapies

Parameter	NAMENDA (Memantine)	AChE inhibitors	Emerging agents
Mechanism	NMDA receptor antagonist	Acetylcholinesterase inhibition	Anti-amyloid, tau-targeting antibodies
Approved For	Moderate to severe AD	Mild to severe AD	Late-stage clinical trials
Cost	Moderate	Lower	Variable
Reimbursement	Widely reimbursed	Widely reimbursed	Pending approval

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FAQs

Q1. What is the primary clinical advantage of NAMENDA over other AD medications?
A1. NAMENDA’s mechanism as an NMDA receptor antagonist provides neuroprotective effects, particularly effective in moderate to severe Alzheimer’s stages, often in combination with AChE inhibitors, to improve cognitive function and reduce neurotoxicity.

Q2. How might patent expiration impact NAMENDA’s market share?
A2. Patent expiry around 2027 may permit generic manufacturers to enter the market, likely leading to significant price reductions and potential erosion of branded sales unless new formulations or indications extend market exclusivity.

Q3. What is the outlook for NAMENDA given the emergence of disease-modifying treatments?
A3. While disease-modifying biologics pose competition, NAMENDA remains relevant for symptom management, especially in advanced stages. Strategic positioning, such as combination therapy and inclusion in treatment algorithms, can sustain its market presence.

Q4. Are there ongoing clinical trials improving NAMENDA’s efficacy?
A4. Currently, research focuses on combination therapies, extended-release formulations, and exploring neuroprotective effects, but no major modifications have surpassed existing indications.

Q5. How do reimbursement policies influence NAMENDA’s accessibility?
A5. Reimbursement frameworks in key markets like the US and Europe favor chronic medications, supporting ongoing prescription volumes. Policy shifts towards cost containment could pose challenges unless value-based models are adopted.

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Key Takeaways

• NAMENDA remains a vital symptomatic therapy for moderate to severe Alzheimer’s, with steady but modest revenue growth projected through 2030.
• The impending patent expiry in 2027 necessitates strategic differentiation, such as new formulations or indications, to sustain revenues.
• Innovation in Alzheimer’s treatment, especially biologics aimed at the underlying pathology, threaten future demand, although NAMENDA’s niche role supports its continued market relevance.
• The evolving regulatory and reimbursement environment will significantly influence pricing, accessibility, and profitability.
• Geographic expansion, especially into emerging markets, offers growth opportunities if pricing and reimbursement align with local healthcare policies.

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References

[1] MarketWatch, “Global Alzheimer’s Disease Pharmacotherapy Market,” 2022.
[2] Alzheimer’s Association, “2020 Alzheimer’s Disease Facts and Figures,” 2020.
[3] MedPage Today, “Pricing and Reimbursement of Alzheimer’s Drugs,” 2022.
[4] U.S. Patent and Trademark Office, “Memantine Patent Details,” 1994.

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This comprehensive analysis provides strategic insights into the current and future market trajectory of NAMENDA, equipping stakeholders with data-driven guidance for decision-making.