MEMANTINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for memantine hydrochloride and what is the scope of patent protection?

Memantine hydrochloride is the generic ingredient in three branded drugs marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Abbvie, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, Allergan, Acme Labs, Ajanta Pharma Ltd, Alembic, Allied, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences, and is included in forty-five NDAs. There is one patent protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Memantine hydrochloride has ten patent family members in nine countries.

There are twenty-eight drug master file entries for memantine hydrochloride. Forty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for MEMANTINE HYDROCHLORIDE

International Patents:	10
US Patents:	1
Tradenames:	3
Applicants:	37
NDAs:	45
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	243
Patent Applications:	4,334
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEMANTINE HYDROCHLORIDE
What excipients (inactive ingredients) are in MEMANTINE HYDROCHLORIDE?	MEMANTINE HYDROCHLORIDE excipients list
DailyMed Link:	MEMANTINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MEMANTINE HYDROCHLORIDE

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

Sponsor	Phase
NeuroSense Therapeutics Ltd.	Phase 2
Mansoura University	Phase 1/Phase 2
University of Chicago	Phase 2/Phase 3

See all MEMANTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		28MG	CAPSULE, EXTENDED RELEASE;ORAL
		21MG	CAPSULE, EXTENDED RELEASE;ORAL
		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 MEMANTINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for MEMANTINE HYDROCHLORIDE

Antiparkinson Agents

Dopamine Agents

Excitatory Amino Acid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for MEMANTINE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for MEMANTINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAMENDA XR	Extended-release Capsules	memantine hydrochloride	7 mg, 14 mg, 21 mg, and 28 mg	022525	1	2013-06-10
NAMENDA	Tablets	memantine hydrochloride	5 mg and 10 mg	021487	14	2007-10-16

US Patents and Regulatory Information for MEMANTINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214651-003	Aug 9, 2021	AB	RX	No	No
Upsher Smith Labs	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090043-002	Jul 31, 2015	AB	RX	No	No
Strides Pharma	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	202350-001	May 23, 2017	AB	RX	No	No
Hetero Labs Ltd V	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	204389-001	Sep 26, 2022	AB	RX	No	No
Aurobindo Pharma Ltd	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	203175-001	Oct 13, 2015	AB	RX	No	No
Unichem	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	200022-002	Oct 13, 2015	AB	RX	No	No

Expired US Patents for MEMANTINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	5,614,560
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	5,061,703*PED
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	5,061,703*PED
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-001	Oct 16, 2003	5,061,703*PED
Allergan	NAMENDA	memantine hydrochloride	SOLUTION;ORAL	021627-001	Apr 18, 2005	5,614,560

EU/EMA Drug Approvals for MEMANTINE HYDROCHLORIDE

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 MEMANTINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	1968684	Modified release formulation of memantine
Eurasian Patent Organization	011446	ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (PREPARATORY SOLID ORAL DOSAGE FORM OF MEMANTINE WITH MODIFIED RELEASE)
Australia	2005265031	Modified release formulation of memantine
European Patent Office	1781261	FORMULATION DE LIBERATION MODIFIEE DE MEMANTINE (MODIFIED RELEASE FORMULATION OF MEMANTINE)
Mexico	PA06014587	FORMULACIONES DE LIBERACION MODIFICADA DE FORMULACIONES DE DOSIFICACION ORAL DE MEMANTINA. (MODIFIED RELEASE FORMULATION OF MEMANTINE.)
Canada	2569015	FORMULATION DE LIBERATION MODIFIEE DE MEMANTINE (MODIFIED RELEASE FORMULATION OF MEMANTINE)

Supplementary Protection Certificates for MEMANTINE HYDROCHLORIDE

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

MEMANTINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Memantine Hydrochloride

Introduction to Memantine Hydrochloride

Memantine hydrochloride is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist primarily used in the treatment of moderate to severe dementia associated with Alzheimer's disease. It does not cure Alzheimer's but can improve memory, awareness, and the ability to perform daily functions by balancing glutamate, a brain chemical involved in memory and learning[3].

Market Growth and Projections

The memantine hydrochloride market is anticipated to experience significant growth over the forecast period from 2023 to 2031. Here are some key projections:

• CAGR and Market Size: The market is expected to grow at a considerable Compound Annual Growth Rate (CAGR), with the global market size projected to increase substantially by 2031. For instance, the market size in 2023 is estimated to be in the millions of USD, and it is forecasted to reach a higher value by 2031[3][4].
• Geographical Expansion: The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America is currently the dominant region due to the availability of generic versions of memantine, while Asia-Pacific is expected to witness significant growth due to increased manufacturing activities by key players[4].

Market Drivers

Several factors are driving the growth of the memantine hydrochloride market:

• Increasing Prevalence of Alzheimer's Disease: The rising number of patients with Alzheimer's disease and other dementia-related conditions is a major driver. As the global population ages, the demand for treatments like memantine is expected to increase[3][4].
• Government Initiatives and Research Funding: Government initiatives to enhance healthcare facilities and increased research funding are contributing to the market's growth. These efforts support the development of new formulations and the expansion of existing treatments[3].
• Pipeline Studies and Clinical Trials: Ongoing and upcoming clinical studies, such as those by Lille University Hospital and Suven Life Sciences Limited, are expected to drive market growth by exploring new uses and efficacy of memantine[4].

Market Restraints

Despite the positive growth trends, there are several restraints affecting the market:

• Patent Expirations: The expiration of patent protection for memantine in various markets has led to a decrease in licensing income. For example, Merz Pharmaceuticals saw a reduction in U.S. licensing income from $183.34 million in 2016 to $138.07 million in 2017-18[4].
• Generic Competition: The entry of generic versions of memantine into the market, such as those launched by Lupin Limited and Dr. Reddy’s Laboratories, can reduce the market share of branded products[4].

Market Segmentation

The memantine hydrochloride market is segmented based on several criteria:

• Formulation: The market is segmented into tablets and capsules. Extended-release capsules, such as those launched by Lupin Limited, are also gaining traction[3][4].
• Distribution Channel: The market is categorized into hospital pharmacies, retail pharmacies, and online pharmacies. The availability of memantine through various distribution channels enhances its accessibility[3].

Regional Analysis

• North America: Currently holds a dominant position due to the availability of generic versions and strong healthcare infrastructure[4].
• Asia-Pacific: Expected to witness significant growth due to the rising focus of key players in manufacturing memantine tablets and capsules[4].

Competitive Landscape

The competitive landscape of the memantine hydrochloride market includes several key players:

• Lupin Limited: Known for launching generic versions of memantine hydrochloride extended-release capsules in the U.S. market[4].
• Dr. Reddy’s Laboratories: Launched memantine hydrochloride tablets in India, equivalent to the generic version of Namenda tablets[4].
• Merz Pharmaceuticals: Although affected by patent expirations, remains a significant player in the market[4].

Financial Trajectory

The financial trajectory of the memantine hydrochloride market is characterized by:

• Revenue Growth: The market is expected to see substantial revenue growth from 2023 to 2031, driven by increasing demand and new market entries[3][4].
• Market Size Forecast: The market size is projected to increase significantly, with forecasts indicating a robust growth rate throughout the forecast period[1][3].

Key Statistics and Trends

• Market Size in 2023: Estimated to be in the millions of USD[3].
• Forecasted Market Size by 2031: Expected to reach a higher value, indicating strong growth[3].
• CAGR: Anticipated to be significant, reflecting the market's robust growth potential[3].

"Memantine treatment is cost-effective, safe, and connected with gains in quality-adjusted life-years, particularly for mild-to-moderate AD patients"[2].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of memantine is crucial for its market dynamics:

• Absorption and Bioavailability: Memantine is rapidly and fully absorbed with almost 100% bioavailability. It reaches maximum plasma concentration within 3-8 hours after oral administration[2].
• Elimination: Primarily excreted by the kidneys, with a significant influence of urine pH on renal clearance[2].

Key Takeaways

• The memantine hydrochloride market is poised for significant growth driven by increasing demand for Alzheimer's disease treatments.
• North America and Asia-Pacific are key regions, with the latter expected to grow rapidly.
• Patent expirations and generic competition are significant restraints.
• The market is segmented by formulation and distribution channel, with tablets and capsules being the primary formulations.
• Key players include Lupin Limited, Dr. Reddy’s Laboratories, and Merz Pharmaceuticals.

FAQs

What is the primary use of memantine hydrochloride?

Memantine hydrochloride is primarily used to treat moderate to severe dementia associated with Alzheimer's disease.

Which regions are expected to drive the growth of the memantine hydrochloride market?

North America is currently the dominant region, while Asia-Pacific is expected to witness significant growth due to increased manufacturing activities.

What are the major drivers of the memantine hydrochloride market?

The rising prevalence of Alzheimer's disease, government initiatives to enhance healthcare facilities, and ongoing clinical studies are major drivers.

How does the expiration of patent protection affect the memantine hydrochloride market?

The expiration of patent protection leads to a decrease in licensing income and increased competition from generic versions.

What is the expected CAGR for the memantine hydrochloride market from 2023 to 2031?

The market is anticipated to grow at a significant CAGR, though the exact percentage varies by report.

Cited Sources

1. Global Memantine HCl Market Size, Scope And Forecast Report - Market Research Intellect
2. The Concentration of Memantine in the Cerebrospinal Fluid of ... - Frontiers in Pharmacology
3. Memantine Market Key Players Analysis 2031 - The Insight Partners
4. Memantine Market Dynamic Demand For Future Growth ... - PharmiWeb
5. Memantine-Derived Schiff Bases as Transdermal Prodrug Candidates - ACS Omega