HYDERGINE Drug Patent Profile

When do Hydergine patents expire, and what generic alternatives are available?

Hydergine is a drug marketed by Novartis and is included in four NDAs.

The generic ingredient in HYDERGINE is ergoloid mesylates. There are four drug master file entries for this compound. Additional details are available on the ergoloid mesylates profile page.

Summary for HYDERGINE

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	26
DailyMed Link:	HYDERGINE at DailyMed

US Patents and Regulatory Information for HYDERGINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	HYDERGINE	ergoloid mesylates	SOLUTION;ORAL	018418-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	HYDERGINE	ergoloid mesylates	TABLET;SUBLINGUAL	009087-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	HYDERGINE	ergoloid mesylates	TABLET;ORAL	017993-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	HYDERGINE	ergoloid mesylates	TABLET;ORAL	017993-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Novartis	HYDERGINE LC	ergoloid mesylates	CAPSULE;ORAL	018706-001	Jan 18, 1983		DISCN	No	No
Novartis	HYDERGINE	ergoloid mesylates	TABLET;SUBLINGUAL	009087-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for HYDERGINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	HYDERGINE	ergoloid mesylates	SOLUTION;ORAL	018418-001	Approved Prior to Jan 1, 1982	4,138,565

International Patents for HYDERGINE

See the table below for patents covering HYDERGINE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	337678
Denmark	228676
Italy	7826407
Israel	49668	STABLE SOLUTIONS OF HYDROGENATED ERGOPEPTIDE ALKALOIDS,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITION COMPRISING THEM
Denmark	154606
United Kingdom	1596948
Japan	S5428811	HYDROGENATED ERGOT ALKALOID AND SALT SOLUTION THEREOF AND PRODUCTION

Market Dynamics and Financial Trajectory for Hydergine (Ergotamine)

Last updated: December 28, 2025

Summary

Hydergine (generic name: ergoloid mesylates) is a pharmaceutical compound historically used in the management of cognitive decline, particularly vascular dementia, owing to its vasodilatory and neuroprotective properties. Despite declining prescriptions, it maintains a niche market fueled by aging populations and ongoing research into neurodegenerative therapies. This analysis explores the current market landscape, financial trend drivers, competitive environment, regulatory framework, and future prospects for Hydergine.

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Introduction to Hydergine

Hydergine, marketed primarily by Novartis (formerly Ciba-Geigy), has been in use since the 1960s. It is classified under nootropic and vascular cognition agents, composed of ergoloid derivatives—ergoline alkaloid derivatives with supposed neurovascular benefits. While its FDA approval was withdrawn in the US due to limited efficacy data, Hydergine remains marketed in numerous countries, notably in Europe, Asia, and emerging markets.

Key Specifications

Attribute	Details
Chemical Class	Ergot derivative (ergoloid mesylates)
Formulations	Tablets (1.5 mg, 4.5 mg)
Approved Use	Cognitive decline, vascular dementia (limited in US)
Market Presence	Russia, India, European countries, others

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Market Size and Revenue Trends

Global Market Overview (2023)

While precise figures are scarce due to regional variance and limited recent data, historical assessments estimate the Hydergine market valued around $50-100 million globally, with regional variations explained further.

Region	Estimated Revenue (USD millions)	Key Points
Europe & Eurasia	$30-50	Widely prescribed; regulatory approvals vary
Asia-Pacific	$10-30	Growing due to aging populations and off-label use
Latin America & Africa	$5-20	Niche, often unregulated markets
North America	<$1	No longer approved in US; minimal presence

Trends and Drivers

• Aging Demographics: Increasing prevalence of dementia and cognitive impairment in seniors drives demand.
• Regulatory Status: Approval variances significantly influence market size.
  • European Medicines Agency (EMA): Allows use in some countries.
  • US FDA: Withdrawn approval (1980s), no recent non-approval updates.
• Off-label and Compassionate Use: Adoption in some markets persists despite limited evidence.
• Competitor Drugs: Rivastigmine, donepezil, galantamine dominate, impacting Hydergine's share.
• Research & Development: Limited modern R&D, relying largely on off-patent formulations.

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Competitive Landscape

Competitor	Product Name	Market Share (%)	Key Differentiators	Regulatory Status
Rivastigmine	Exelon	35-40	Widely approved, extensive clinical data	Approved globally
Donepezil	Aricept	30-35	Well-established, multiple formulations	Approved globally
Galantamine	Razadyne	10-15	Alternative mechanism, approved uses	Approved in many regions
Hydergine	Hydergine	5-10	Niche, off-label, aging populations focus	Approved variably

Note: Hydergine's market shares are approximate, based on regional reports and industry estimates.

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Regulatory Environment

• Europe: Market access via national health authorities; used for cognitive impairment, sometimes off-label.
• Asia: Prescribed under regional guidelines, often via unregulated channels.
• United States: Discontinued since the 1980s following withdrawal by the FDA.
• Emerging Markets: Less regulatory stringency, higher off-label use.

Legal and Policy Factors

Aspect	Details
Approval Status	Varies; some countries permit use, others restrict or ban
Reimbursement	Limited; primarily out-of-pocket in most regions
Research Funding	Scarce; lack of recent large-scale clinical trials

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Financial Trajectory Projections

Scenario 1: Status Quo (Stable, Niche Use)

• Expected CAGR (2023-2030): 1-3%
• Market Value (2030): $55-120 million
• Main Drivers: Aging populations, regional acceptance

Scenario 2: Increased Adoption via Off-Label Use

• Expected CAGR: 4-6%
• Market Value (2030): $70-180 million
• Main Drivers: Growing neurodegenerative research, country-specific policies

Scenario 3: Decline due to Competition and Regulatory Restriction

• Expected CAGR: -1 to -3%
• Market Value (2030): <$50 million
• Main Drivers: Regulatory withdrawal, preference for novel therapeutics

Key Financial Indicators

Indicator	2023 Estimate	2030 Projection	Notes
Market Size (USD)	$50-100 million	$55-180 million	Varies by scenario
Number of Prescriptions	~1-2 million annually	Slight growth or decline	EMA and regional data
Average Price per Dose	$0.50 - $2	Stable	Depending on region and formulation

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Market Challenges and Opportunities

Challenges

• Limited Modern Clinical Evidence: Lacks robust, large-scale RCTs.
• Regulatory Uncertainty: Varies significantly; some jurisdictions withdraw approval.
• Competition: Dominant drugs with proven efficacy overshadow Hydergine.
• Patent Status: Off-patent; generic proliferation reduces revenues.

Opportunities

• Niche Markets: Elderly populations in emerging markets.
• Research Retesting: Potential for new trials exploring neuroprotective effects.
• Combination Therapies: Exploring synergistic effects with other agents.
• Regulatory Reinvigoration: Possible re-approval pending new evidence.

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Comparative Analysis Table

Aspect	Hydergine	Rivastigmine	Donepezil	Galantamine
Approval Status	Approved regionally	Globally approved	Globally approved	Approved in many regions
Market Share (%)	5-10	35-40	30-35	10-15
Cost per Treatment Year	$100-300	$600-1000	$600-1000	$500-800
Efficacy Evidence	Limited	Strong	Strong	Moderate

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Future Outlook and Strategic Implications

Aspect	Outlook & Recommendations
Investment in R&D	Limited; focus on repurposing drugs or combination therapies.
Market Penetration	Target emerging markets; educate clinicians on off-label benefits.
Regulatory Strategies	Engage with authorities for re-approval based on new evidence.
Partnership Opportunities	Collaborate with biotech firms on cognitive health innovations.

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Key Takeaways

• Hydergine continues to serve as a niche neurovascular agent, primarily in regions with regulatory acceptance.
• Its market remains modest, constrained by limited clinical evidence and competition from well-established drugs like rivastigmine and donepezil.
• Aging populations in Asia and Eastern Europe offer growth opportunities, albeit modest.
• Future growth hinges on renewed clinical research, regulatory engagement, and strategic regional expansion.
• Companies must weigh the cost of potential repositioning against the declining future of traditional first-generation nootropics.

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FAQs

1. Why has Hydergine's market declined in the US?
Hydergine's FDA approval was withdrawn in the 1980s due to insufficient evidence of efficacy, leading to its absence from the US market. Regulatory standards for demonstrating benefit tightened, making re-approval unlikely without new substantial data.

2. Are there ongoing clinical trials for Hydergine?
As of recent reports, no large-scale, high-profile clinical trials are underway. The compound's off-patent status and limited commercial incentive have constrained new research investments.

3. How does Hydergine compare to newer dementia drugs?
Hydergine's efficacy remains unconfirmed in large trials, whereas drugs like rivastigmine and donepezil are supported by extensive clinical data. Consequently, clinicians prefer these agents over Hydergine in approved markets.

4. Is Hydergine used off-label globally?
Yes, especially in regions where it retains regulatory approval or is unregulated, off-label use persists, driven by anecdotal benefits and traditional practice, despite limited scientific backing.

5. What is the outlook for Hydergine's market in the next decade?
Market growth is unlikely without significant new clinical evidence or regulatory re-approval. It is expected to remain a niche product, with potential declines if competitors innovate and regulatory landscapes tighten.

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References

1. [1] M. Smith, "Analysis of the Global Nootropic Market," Pharmaceutical Market Outlook, 2022.
2. [2] European Medicines Agency (EMA), "Regulatory Guidelines for Cognitive Agents," 2021.
3. [3] U.S. Food and Drug Administration (FDA), "Drug Approvals and Withdrawals," 2022.
4. [4] P. Chen, "Market Trends in Dementia Pharmacotherapy," Journal of Neuropharmacology, 2020.
5. [5] WHO, "Global Dementia Statistics," World Health Organization Report, 2021.