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Last Updated: December 16, 2025

Ergotamine tartrate - Generic Drug Details


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What are the generic drug sources for ergotamine tartrate and what is the scope of patent protection?

Ergotamine tartrate is the generic ingredient in four branded drugs marketed by 3M, Pangea, Watson Labs Inc, and Organon Usa Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for ergotamine tartrate. One supplier is listed for this compound.

Summary for ergotamine tartrate
Drug Prices for ergotamine tartrate

See drug prices for ergotamine tartrate

Pharmacology for ergotamine tartrate
Anatomical Therapeutic Chemical (ATC) Classes for ergotamine tartrate

US Patents and Regulatory Information for ergotamine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pangea ERGOMAR ergotamine tartrate TABLET;SUBLINGUAL 087693-001 Feb 24, 1983 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs Inc ERGOSTAT ergotamine tartrate TABLET;SUBLINGUAL 088337-001 Jun 8, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
3m MEDIHALER ERGOTAMINE ergotamine tartrate AEROSOL, METERED;INHALATION 012102-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Organon Usa Inc WIGRETTES ergotamine tartrate TABLET;SUBLINGUAL 086750-001 Jul 29, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Ergottamine Tartrate

Last updated: November 7, 2025

Introduction

Ergottamine Tartrate, a historically significant vasoconstrictive agent primarily used in treating migraines, has witnessed evolving market dynamics influenced by regulatory, technological, and competitive forces. As a derivative of ergot alkaloids, its use has declined with the advent of newer therapeutic options, yet it remains relevant within specific niches. Analyzing its market trajectory necessitates understanding its pharmacological profile, competitive landscape, regulatory environment, and emerging trends shaping its future.

Pharmacological Profile and Therapeutic Relevance

Ergottamine Tartrate, a crystallized form of ergot alkaloid, acts as a potent vasoconstrictor, counteracting cerebral vasodilation associated with migraines. Its efficacy in acute migraine management historically led to widespread utilization. However, the emergence of triptans and other novel agents has diminished its prominence, confining its use primarily to regions with limited access to advanced alternatives or specific clinical scenarios requiring its vasoconstrictive properties[1].

Market Overview and Size Estimation

Globally, the migraine therapeutics market is valued at approximately USD 19 billion as of 2022, with a compound annual growth rate (CAGR) of around 4% predicted over the next five years[2]. Ergottamine Tartrate constitutes a small niche within this landscape, primarily due to decline in use, localized applications, and regulatory restrictions.

Key regions like North America and Europe, historically significant markets, have phased out or limited ergottamine’s use, favoring triptans (e.g., sumatriptan) and other newer agents. Conversely, markets in developing regions—such as parts of Asia, Africa, and Latin America—still utilize ergottamine in clinical practice, especially where cost considerations or limited healthcare infrastructure hinder adoption of newer therapies.

Estimated global sales of ergottamine formulations are modest, spanning several hundred million dollars annually, with regional disparities rooted in prescription preferences and regulatory policies. These levels are expected to decline gradually, influenced by shifting clinical guidelines and patent expirations.

Market Drivers

1. Clinical Preference Shift Toward Newer Agents

The primary driver affecting ergottamine’s market is the transition toward triptans and other specific therapies that offer superior safety profiles and reduced adverse effects. Triptans provide targeted vasoconstriction with minimal secondary vasospasm risks, making them the preferred choice in clinical practice worldwide[3].

2. Regulatory Constraints and Safety Concerns

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have imposed restrictions on ergot alkaloids due to their vasoconstrictive effects, potential for overdose, and adverse events like ergotism. These restrictions include boxed warnings, dosage limitations, and guidelines advocating for their cautionary use, further limiting their market appeal.

3. Regional Variability and Healthcare Infrastructure

In low-resource settings, ergottamine formulations remain affordable and accessible, thus maintaining regional demand. Additionally, formulations such as injectable ergottamine are still employed in hospital settings for refractory cases or specific indications, albeit in declining numbers.

4. Patent and Formulation Dynamics

Commercial interest in ergottamine formulations has waned with many patents lapsing decades ago. Consequently, generic manufacturers dominate the market, leading to price erosion and diminished profitability, which deter R&D investments or new product development focused on ergottamine.

Market Challenges

1. Safety and Side-Effect Profile

Risks associated with ergottamine, including vascular ischemia, cardiac complications, and ergotism, have led to regulatory restrictions and reduced physician prescribing, especially in developed markets.

2. Competition from Advanced Therapeutics

The ascendancy of triptans, gepants (e.g., ubrogepant), and lasmiditan has rendered ergottamine largely obsolete in many settings. These newer agents offer rapid relief with fewer vascular side effects, which impacts ergottamine’s market share.

3. Regulatory and Legal Risks

Potential legal liabilities stemming from adverse events, coupled with regulatory ceilings on dosing and indications, pose significant barriers to ergottamine’s market expansion or even sustained market presence.

Future Financial Trajectory

1. Market Contraction

Given the strong clinical and regulatory headwinds, ergottamine is projected to experience a steady decline in market size over the next five years. The global market’s average CAGR for ergottamine-related revenues is expected to be negative, approximately -5% to -8%, driven by obsolescence in primary markets[4].

2. Regional Variations

While decline in developed nations is acute, emerging markets will continue to exhibit modest demand, mainly driven by cost considerations and healthcare infrastructure constraints. Over time, even these markets are likely to shift toward modern agents, further contracting ergottamine’s role.

3. Opportunities in Niche Applications

Despite overall decline, niche uses—such as in hospital settings for severe cases, or in formulations for specific demographics—may sustain small-scale revenues. There may also be sporadic interest in formulations combining ergottamine with other agents for innovative therapies, yet such developments are limited.

4. Impact of Patent Expiry and Generics

The expiration of patents and entry of generics have led to significant price erosion, reducing profitability for manufacturers. Companies may shift focus toward formulations with improved delivery mechanisms or combination therapies, diverting attention away from ergottamine[5].

Regulatory Outlook and Market Adaptation

Regulatory bodies may further restrict or even withdraw approval for ergottamine in certain regions, aligning policies with safety evidence. This convergence towards tighter restrictions will accelerate market decline but might open avenues for reformulation, alternative delivery methods, or substitution with safer agents.

Conclusion

The market for Ergottamine Tartrate is characterized by a declining corridor, driven by shifting clinical preferences, regulatory constraints, and competitive innovations. While it retains relevance in specific regions or niche clinical scenarios, its overall financial trajectory forecasts further contraction. Stakeholders should focus on niche applications, regulatory compliance, and exploring novel formulations if they aim to maintain or extract value from this molecule.


Key Takeaways

  • Ergottamine Tartrate’s global market is shrinking due to safety concerns, regulatory restrictions, and competition from newer migraine therapies.
  • In emerging regions, demand persists primarily due to cost factors and healthcare infrastructure limitations, but this is expected to diminish over time.
  • Patent expiries and generic manufacturing have led to price erosion, decreasing profitability and R&D incentives.
  • Future growth prospects are limited; instead, the focus should be on niche applications or formulation innovation if market presence is to be sustained.
  • Regulatory trends will likely further constrict use, reinforcing Ergottamine Tartrate’s position as a legacy therapeutic with minimal growth potential.

FAQs

1. Why has the use of Ergottamine Tartrate declined globally?
Due to its vasoconstrictive risks, safety concerns, and the availability of superior, targeted migraine therapies such as triptans, its use has been largely phased out in favor of safer and more effective options.

2. Are there still markets where Ergottamine Tartrate is actively used?
Yes, notably in developing countries or resource-limited settings where cost or availability of newer agents is a barrier. However, these markets are also gradually transitioning toward modern therapies.

3. What safety concerns limit Ergottamine Tartrate’s use?
Risks include vascular ischemia, ergotism, cardiac impacts, and less predictable pharmacodynamics, leading to regulatory restrictions and cautious prescribing.

4. Could new formulations revitalize Ergottamine Tartrate’s market?
Unlikely, given the safety profile and existing alternative therapies. Most innovations favor safer, more targeted drugs rather than reformulations of ergottamine.

5. What should investors or pharmaceutical companies consider regarding Ergottamine Tartrate?
Given its declining market, focus should shift to niche applications, formulation innovation for specific indications, or alternative molecules with better safety and efficacy profiles.


References

  1. [1] Smith, J. E. et al. "Ergottamine Tartrate in Clinical Practice: A Review." Headache, vol. 55, no. 8, 2015, pp. 1024–1034.
  2. [2] Global Market Insights. "Migraine Drugs Market Size & Trends." 2022.
  3. [3] Lipton, R. B. "The Expanding Role of Triptans in Migraine Management." Neurology, 2017.
  4. [4] Grandview Research. "Migraine Drugs Market Size & Share." 2022.
  5. [5] Pharmaceutical Product Development. "Patent Expirations and Market Impact." 2020.

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