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Last Updated: December 22, 2024

GALANTAMINE HYDROBROMIDE Drug Patent Profile


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When do Galantamine Hydrobromide patents expire, and when can generic versions of Galantamine Hydrobromide launch?

Galantamine Hydrobromide is a drug marketed by Aurobindo Pharma, Barr, Impax Labs, Norvium Bioscience, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc. and is included in nineteen NDAs.

The generic ingredient in GALANTAMINE HYDROBROMIDE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Galantamine Hydrobromide

A generic version of GALANTAMINE HYDROBROMIDE was approved as galantamine hydrobromide by BARR on August 28th, 2008.

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Summary for GALANTAMINE HYDROBROMIDE
Drug patent expirations by year for GALANTAMINE HYDROBROMIDE
Drug Prices for GALANTAMINE HYDROBROMIDE

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Recent Clinical Trials for GALANTAMINE HYDROBROMIDE

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

SponsorPhase
Vanderbilt University Medical CenterPhase 1
Ortho-McNeil Neurologics, Inc.Phase 4
Duke UniversityPhase 4

See all GALANTAMINE HYDROBROMIDE clinical trials

Pharmacology for GALANTAMINE HYDROBROMIDE
Medical Subject Heading (MeSH) Categories for GALANTAMINE HYDROBROMIDE
Anatomical Therapeutic Chemical (ATC) Classes for GALANTAMINE HYDROBROMIDE
Paragraph IV (Patent) Challenges for GALANTAMINE HYDROBROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RAZADYNE ER Extended-release Capsules galantamine hydrobromide 16 mg and 24 mg 021615 1 2006-03-11
RAZADYNE ER Extended-release Capsules galantamine hydrobromide 8 mg 021615 1 2006-03-02
RAZADYNE Tablets galantamine hydrobromide 4 mg, 8 mg and 12 mg 021169 14 2005-02-28

US Patents and Regulatory Information for GALANTAMINE HYDROBROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077590-001 May 29, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077593-001 Sep 11, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077589-003 Jun 22, 2009 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

GALANTAMINE HYDROBROMIDE Market Analysis and Financial Projection Experimental

Galantamine Hydrobromide Market Dynamics and Financial Trajectory

Market Overview

The global galantamine hydrobromide market is experiencing significant growth, driven by several key factors. Galantamine hydrobromide, a medication used to treat Alzheimer’s disease, is witnessing increased demand due to the rising prevalence of cognitive disorders and the expanding geriatric population[2][3][5].

Key Drivers

Increasing Prevalence of Alzheimer’s Disease

The primary driver of the galantamine hydrobromide market is the increasing prevalence of Alzheimer’s disease. According to the World Health Organization (WHO), around 55 million people globally suffer from dementia, and this number is expected to rise, driving the demand for effective treatments[3].

Expanding Geriatric Population

The geriatric population, which is more prone to Alzheimer’s disease, is growing rapidly. This demographic shift is fueling the market growth as older individuals require more healthcare services and medications to manage cognitive decline[2][3].

Advancements in Drug Formulations

Innovations in drug formulations and the integration of digital health tools are transforming the management of Alzheimer’s disease. These advancements include better drug delivery systems, mobile apps, and wearables that help monitor patient adherence and track cognitive function[5].

Increasing Research and Development

Pharmaceutical companies are investing heavily in research and development to enhance the efficacy of galantamine hydrobromide. This includes collaborations and partnerships aimed at developing more effective therapies and improving patient outcomes[2][5].

Market Restraints

Stringent Regulatory Requirements

One of the significant challenges facing the galantamine hydrobromide market is the stringent regulatory requirements for drug approval. These regulations can lead to delays in product launches and pose a barrier to market entry for new players[2][3].

Availability of Alternative Treatments

The presence of alternative treatment options for Alzheimer’s disease can impact the market share of galantamine hydrobromide. Adverse effects and contraindications associated with the drug can also limit its use in certain patient populations[2][3].

Side Effects and Contraindications

Side effects such as headache, nausea, vomiting, and weight loss can negatively impact the market growth. Additionally, contraindications in certain patient groups can restrict the drug's use[3].

Market Opportunities

Emerging Markets

Emerging markets in developing countries offer significant growth opportunities due to improving healthcare infrastructure and rising disposable incomes. Countries like India, China, and Brazil are experiencing increased demand for Alzheimer’s treatments, providing a fertile ground for market expansion[2][5].

Strategic Partnerships and Acquisitions

Collaborations and partnerships between pharmaceutical companies can lead to new market opportunities. These strategic alliances can facilitate the development of new products, enhance distribution networks, and drive market growth[5].

Digital Health Integration

The integration of digital health tools is transforming the management of Alzheimer’s disease. This trend is expected to continue, with galantamine hydrobromide playing a crucial role in these digital health ecosystems[5].

Regional Analysis

North America

North America accounted for the largest revenue share in the galantamine hydrobromide market in recent years. This is attributed to major commercial operations, advanced healthcare facilities, and the presence of established healthcare companies in the region[3].

Asia Pacific

The Asia Pacific region is expected to register a robust revenue CAGR over the forecast period. This growth is driven by supportive government initiatives, the presence of an aging population, and increasing investments in research and development by healthcare companies in countries like China and India[3].

Financial Trajectory

Market Size and Projections

The global galantamine hydrobromide market size is projected to grow significantly over the forecast period from 2023 to 2031. The market is expected to register a steady revenue CAGR, driven by the increasing prevalence of Alzheimer’s disease and the expanding geriatric population[1][2][3].

Revenue Growth

Key factors contributing to revenue growth include rising investments in the pharmaceutical industry, the increasing number of specialty clinics globally, and supportive government initiatives to promote health awareness. The market is also benefiting from innovations in drug formulations and the growing demand in emerging markets[3][5].

Funding and Capital Requirements

Companies involved in the development and commercialization of galantamine hydrobromide often require significant capital to fund research and development, clinical trials, and market expansion. This can involve private placements, public offerings, and partnerships to secure the necessary funding[4].

Key Takeaways

  • The galantamine hydrobromide market is driven by the increasing prevalence of Alzheimer’s disease and the expanding geriatric population.
  • Innovations in drug formulations and the integration of digital health tools are key drivers of market growth.
  • Stringent regulatory requirements and the availability of alternative treatments pose challenges to market players.
  • Emerging markets in developing countries offer significant growth opportunities.
  • Strategic partnerships and acquisitions are crucial for market expansion and product development.

FAQs

What are the primary drivers of the galantamine hydrobromide market?

The primary drivers of the galantamine hydrobromide market include the increasing prevalence of Alzheimer’s disease and the expanding geriatric population.

What are the major challenges facing the galantamine hydrobromide market?

The major challenges include stringent regulatory requirements for drug approval, the availability of alternative treatment options, and side effects associated with the drug.

Which regions are expected to see significant growth in the galantamine hydrobromide market?

North America and the Asia Pacific region are expected to see significant growth, with the latter registering a robust revenue CAGR due to supportive government initiatives and increasing investments in research and development.

How is the integration of digital health tools impacting the galantamine hydrobromide market?

The integration of digital health tools, including mobile apps and wearables, is transforming the management of Alzheimer’s disease by improving patient adherence, tracking cognitive function, and enabling remote healthcare management.

What role do strategic partnerships play in the galantamine hydrobromide market?

Strategic partnerships and acquisitions are crucial for market expansion, facilitating the development of new products, enhancing distribution networks, and driving market growth.

Sources:

  1. Market Research Intellect, Global Galantamine Hydrobromide API Market Size, Trends and Forecasts 2023-2031, December 2024.
  2. MarkWide Research, Global Galantamine Hydrobromide Market 2024-2032, 2024.
  3. Reports and Data, Galantamine Hydrobromide Market, 2024.
  4. Alpha Cognition Inc., 2023 Year-End Management’s Discussion and Analysis, January 2024.
  5. Market Research Intellect, Future Outlook of the Galantamine Hydrobromide Market and Its Impact on Global Healthcare, November 2024.

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