Galantamine hydrobromide - Generic Drug Details

What are the generic sources for galantamine hydrobromide and what is the scope of freedom to operate?

Galantamine hydrobromide is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Barr, Impax Labs, Norvium Bioscience, Sun Pharm, Watson Labs, Janssen Pharms, 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 twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for galantamine hydrobromide. Twelve suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for galantamine hydrobromide

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	22
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	22
Drug Prices:	Drug price trends for galantamine hydrobromide
What excipients (inactive ingredients) are in galantamine hydrobromide?	galantamine hydrobromide excipients list
DailyMed Link:	galantamine hydrobromide at DailyMed

See drug prices for galantamine hydrobromide

Recent Clinical Trials for galantamine hydrobromide

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 1
Ortho-McNeil Neurologics, Inc.	Phase 4
Duke University	Phase 4

See all galantamine hydrobromide clinical trials

Generic filers with tentative approvals for GALANTAMINE HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		12MG	TABLET; ORAL
		8MG	TABLET; ORAL
		4MG	TABLET; 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 galantamine hydrobromide

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for galantamine hydrobromide

Cholinesterase Inhibitors

Nootropic Agents

Parasympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for galantamine hydrobromide

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

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
Sun Pharm	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	090178-003	Feb 2, 2011	AB	RX	No	No
Sun Pharm	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	090178-002	Feb 2, 2011	AB	RX	No	No
Barr	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	078189-001	Sep 15, 2008	AB	RX	No	No
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005		DISCN	Yes	No
Sun Pharm	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	090178-001	Feb 2, 2011	AB	RX	No	No
Hikma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	077608-001	Feb 11, 2009		DISCN	No	No
Apotex Inc	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	077781-003	Sep 27, 2011		DISCN	No	No

Expired US Patents for galantamine hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-001	Feb 28, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-001	Feb 28, 2001
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	SOLUTION;ORAL	021224-001	Jun 22, 2001

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.