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Last Updated: December 22, 2024

MEMANTINE HYDROCHLORIDE Drug Patent Profile


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

Memantine Hydrochloride is a drug 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, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, 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-four NDAs.

The generic ingredient in MEMANTINE 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.

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Drug patent expirations by year for MEMANTINE HYDROCHLORIDE
Recent Clinical Trials for MEMANTINE HYDROCHLORIDE

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

SponsorPhase
NeuroSense Therapeutics Ltd.Phase 2
Mansoura UniversityPhase 1/Phase 2
Alzheimer's Drug Discovery FoundationPhase 3

See all MEMANTINE HYDROCHLORIDE clinical trials

Pharmacology for MEMANTINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for MEMANTINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for MEMANTINE HYDROCHLORIDE
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
Lannett Co Inc MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 207236-001 Nov 10, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Lifesciences MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090961-002 Jul 10, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203293-001 Aug 3, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205905-004 Sep 28, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 202350-001 May 23, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

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