GALANTAMINE HYDROBROMIDE - Generic Drug Details

What are the generic sources for galantamine hydrobromide and what is the scope of patent protection?

Galantamine hydrobromide is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Barr, Impax Labs, Pharmobedient, Sun Pharm, Watson Labs, Janssen Pharms, Hikma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, 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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	22
Patent Applications:	1,545
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
Duke University	Phase 4
Ortho-McNeil Neurologics, Inc.	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
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005		DISCN	Yes	No
Barr	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	077605-003	Aug 28, 2008	AB	RX	No	No
Aurobindo Pharma Ltd	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	090957-001	Mar 29, 2011	AB	RX	No	No
Pharmobedient	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	077603-002	Aug 28, 2008		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	SOLUTION;ORAL	021224-001	Jun 22, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005

Market Dynamics and Financial Trajectory for Galantamine Hydrobromide

Last updated: July 27, 2025

Introduction

Galantamine hydrobromide, a cholinesterase inhibitor primarily indicated for cognitive impairment in Alzheimer’s disease, has experienced fluctuating market dynamics over the past decade. Its commercial trajectory hinges on evolving regulatory landscapes, patent statuses, competitive alternatives, and emerging therapeutic indications. Understanding these factors is vital for stakeholders seeking to assess its market potential and forecast future financial outcomes.

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Market Landscape and Pharmacological Profile

Galantamine hydrobromide, first approved for Alzheimer’s disease (AD) in various regions, leverages its dual mechanism—reversible inhibition of acetylcholinesterase and allosteric modulation of nicotinic receptors—to improve synaptic function. Its pharmacodynamics position it as a second-line treatment following initial therapies like donepezil or rivastigmine [1]. The compound’s market share is notably influenced by its efficacy profile, safety, and comparative benefits over newer agents.

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Market Drivers

Prevalence of Alzheimer’s Disease

The burgeoning global AD population is a principal driver. According to the World Health Organization, approximately 55 million people were living with dementia in 2020, expected to nearly triple by 2050. The high unmet medical need sustains demand for cholinesterase inhibitors, including galantamine, especially in regions with established prescribing habits [2].

Regulatory Approvals and Patent Status

Initially launched by Janssen-Cilag (Eisai), patent protections for galantamine expired or are nearing expiry in several jurisdictions, leading to increased generic competition, which exerts downward pressure on prices and profitability. Notably, in the EU and US, generic versions have been available since the late 2010s. This shift has affected revenue streams but simultaneously expanded access.

Market Penetration and Prescriber Preferences

Despite competition, galantamine maintains a niche in specific markets due to established safety profiles and familiarity among clinicians. Additionally, its availability as a generic enhances accessibility, especially in cost-sensitive regions. Prescriber preference continues to favor newer agents with potentially superior efficacy or better tolerability profiles, such as memantine or combination therapies.

Emerging Indications and Formulations

Research exploring galantamine's application beyond AD, such as for mild cognitive impairment (MCI) or vascular dementia, remains inconclusive but continues to influence market perception. Furthermore, novel formulations—extended-release or combination therapies—might modify its revenue trajectory.

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Competitive Dynamics

Generic Competition

The expiration of patents has considerably increased generic market penetration. Generic drugs typically constitute over 80% of prescriptions for Alzheimer’s therapeutics, leading to significant price erosion [3].

Innovative Therapies

Monoclonal antibodies like aducanumab and lecanemab offer disease-modifying potential, threatening traditional symptomatic treatments like galantamine. While these biologics are costly and have safety concerns, they significantly shift the treatment paradigm.

Pharmacoeconomic and Reimbursement Landscape

Healthcare systems’ reimbursement policies impact market viability. Countries with national health services tend to favor cost-effective generics, thus constraining revenue streams for branded galantamine products.

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Financial Trajectory Analysis

Revenue Trends

Historical data indicates steady decline in revenues for branded galantamine products after patent expiry, with an acceleration post-generic entry. In the US, sales peaked before 2016 but declined markedly afterward, with estimated revenues falling below $200 million annually [4].

Profitability and Cost Structures

Manufacturing costs for generic formulations remain low; however, marketing and regulatory expenses persist. The shift toward commoditization has compressed profit margins, compelling manufacturers to explore niche markets or reformulations to sustain profitability.

Future Outlook

Forecasts suggest a continued decline in traditional markets, tempered by emerging opportunities in off-label indications or combination therapies. However, the revenue plateau risks further erosion unless new formulations or indications are successfully developed. The increasing adoption of digital and personalized medicine may also influence treatment landscapes.

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Regulatory and Policy Impacts

Regulatory pathways are pivotal for lifecycle extension. Some companies pursue drug reformulation or new delivery methods (e.g., transdermal patches) to regain market share and patent life. Additionally, policy initiatives prioritizing cost containment can pressure prices, further influencing financial trajectories.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Focus on innovation through new formulations, expanded indications, or combination therapies to counteract generic erosion.
• Investors: Monitor patent statuses, regulatory approvals, and competitive pipelines to inform valuation and risk assessment.
• Healthcare Providers: Balance efficacy, safety, and cost when prescribing, considering the dynamic availability of generics and emerging therapies.

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Key Takeaways

• Evolving Patent Landscape: Patent expirations have led to increased generic competition, reducing revenues for branded galantamine hydrobromide.
• Market Decline Expected: Current trends forecast a continued decline in traditional markets unless innovation or new indications are secured.
• Competing Therapies: The advent of disease-modifying biologics and improved symptomatic treatments challenge galantamine's market positioning.
• Cost-Driven Reimbursement: Price sensitivity and reimbursement policies favor generics, constraining profit margins.
• Growth Opportunities: Emerging formulations, off-label uses, and combination therapies may provide future growth avenues.

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FAQs

1. How does patent expiration affect the financial outlook of galantamine hydrobromide?
Patent expiry exposes branded formulations to generic competition, leading to price reductions, decreased revenues, and reduced profit margins—significantly influencing overall financial performance.

2. Are there ongoing efforts to develop new formulations or indications for galantamine?
Yes, research explores extended-release formulations, alternative delivery systems, and off-label uses such as for mild cognitive impairment, although regulatory approval remains pending.

3. How do generics impact the competitive landscape?
Generics sharply decrease prices and market share for branded drugs, making revenue recovery difficult without innovation or target expansion.

4. What role do emerging Alzheimer’s treatments play in shaping galantamine’s market?
Disease-modifying biologics like aducanumab and lecanemab offer new therapeutic paradigms, potentially diminishing the role of symptomatic agents like galantamine.

5. Can galantamine hydrobromide regain market share?
Regaining market share would require differentiation through novel formulations, new indications, or combination therapies that clearly outperform existing options.

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References

[1] Birks, J. (2006). Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database of Systematic Reviews.
[2] World Health Organization. (2021). Dementia Fact Sheet.
[3] IQVIA. (2022). Global Prescribing Trends in Alzheimer’s Disease.
[4] EvaluatePharma. (2021). Sales Data and Market Trends for Alzheimer’s Therapeutics.

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Disclaimer: The analysis provided is for informational and strategic planning purposes; actual market conditions may vary.