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Last Updated: December 12, 2025

CAFFEINE; ERGOTAMINE TARTRATE - Generic Drug Details


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What are the generic drug sources for caffeine; ergotamine tartrate and what is the scope of freedom to operate?

Caffeine; ergotamine tartrate is the generic ingredient in four branded drugs marketed by Novartis, Cosette, Chartwell Rx, Anda Repository, Hikma Intl Pharms, and Organon Usa Inc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for CAFFEINE; ERGOTAMINE TARTRATE
Pharmacology for CAFFEINE; ERGOTAMINE TARTRATE

US Patents and Regulatory Information for CAFFEINE; ERGOTAMINE TARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Intl Pharms ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040510-001 Sep 17, 2004 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Cosette MIGERGOT caffeine; ergotamine tartrate SUPPOSITORY;RECTAL 086557-001 Oct 4, 1983 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx CAFERGOT caffeine; ergotamine tartrate TABLET;ORAL 084294-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Novartis CAFERGOT caffeine; ergotamine tartrate SUPPOSITORY;RECTAL 009000-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Novartis CAFERGOT caffeine; ergotamine tartrate TABLET;ORAL 006620-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Organon Usa Inc WIGRAINE caffeine; ergotamine tartrate TABLET;ORAL 086562-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Anda Repository ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040590-001 Sep 16, 2005 RX No Yes ⤷  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 the Pharmaceutical Drugs: Caffeine and Ergotamine Tartrate

Last updated: July 29, 2025


Introduction

The pharmaceutical landscape for caffeine and ergotamine tartrate encompasses distinct market drivers, regulatory environments, and therapeutic applications. As cornerstone compounds in their respective domains, their market trajectories are shaped by scientific innovation, patent landscapes, prevalence of indications, and regulatory policies. This analysis provides a comprehensive overview of current market dynamics and projected financial trajectories for caffeine and ergotamine tartrate, aiding stakeholders in strategic decision-making.


Market Overview: Caffeine

Therapeutic and Non-therapeutic Applications

Caffeine, a central nervous system stimulant, remains one of the most widely consumed psychoactive substances globally. Its diverse applications extend across pharmaceuticals, nutraceuticals, and functional foods. In pharmaceuticals, caffeine is primarily employed as an adjuvant in analgesic formulations, treatment of apnea in preterm infants, and in diagnostic procedures such as the caffeine challenge test used in allergy testing.

Market Drivers

  • Rising Consumption of Over-the-Counter (OTC) Products: The ubiquity of caffeine in OTC medications and energy products sustains consistent demand.
  • Growing Awareness of Cognitive Enhancement: The trend toward nootropics and cognitive health supports the expansion of caffeine-based products.
  • Expanding Functional Food and Beverage Markets: The booming coffee and energy drink sectors serve as significant non-pharmaceutical drivers, indirectly impacting pharmaceutical applications.

Regulatory Landscape

Caffeine's regulatory environment remains relatively stable, with the FDA classifying it as generally recognized as safe (GRAS) for consumable products. Nevertheless, safety concerns over high doses, especially in energy drinks, continue to influence regulatory scrutiny.

Market Size and Financial Trajectory

The global caffeine market was valued at approximately USD 15 billion in 2022, with an expected compound annual growth rate (CAGR) of around 4.2% through 2030 [1]. Pharmaceutical sales constitute a smaller segment but are resilient, driven by consistent demand for medical formulations. The sector benefits from patent protections on specific formulations and combination products, though generic proliferation limits price escalation.


Market Overview: Ergotamine Tartrate

Therapeutic Indications and Usage

Ergotamine tartrate, an alkaloid derived from the Claviceps purpurea fungus, primarily functions as an anti-migraine agent, particularly in the treatment of acute migraine attacks. Historically, it played a broader role in vascular conditions but has seen declines due to the advent of newer modalities.

Market Drivers

  • Migraine Prevalence: With global migraine prevalence estimated at approximately 15%, the demand for effective acute treatments remains significant [2].
  • Introduction of Modern Alternatives: The replacement of ergotamine with triptans in many markets has pressured sales, but a niche persists for patients intolerant or unresponsive to newer agents.
  • Regulatory Changes and Safety Concerns: Strict contraindications related to vasoconstrictive effects have limited widespread use, impacting market size.

Regulatory and Patent Landscape

Many formulations of ergotamine tartrate are now available as generic drugs, reducing R&D incentives and limiting new patent filings. Regulatory agencies have tightened restrictions on dosing and contraindications, affecting the commercial viability for new formulations.

Market Size and Financial Outlook

The global ergotamine tartrate market was valued at approximately USD 200 million in 2022, with a projected CAGR of about 2.0% through 2030 [3]. Growth is sluggish due to the availability of superior therapies and regulatory restrictions. Economically, the market is characterized by commoditized generics, with limited scope for premium pricing.


Market Dynamics Comparison

Aspect Caffeine Ergotamine Tartrate
Market Size (2022) USD 15 billion (overall, pharmaceutical segment smaller) USD 200 million
CAGR (2023-2030) 4.2% 2.0%
Key Drivers Cognitive and functional health trends; OTC demand Migraine prevalence; shifting therapeutic preferences
Regulatory Environment Stable, GRAS status; safety concerns in high doses Stricter, due to vasoconstrictive risks; limited new formulations
Innovation and R&D Moderate, with ongoing product innovations Minimal, primarily generic market presence
Patent Landscape Several formulations patented, but generic proliferation prevalent Mostly off-patent; fierce generic competition

Financial Trajectory and Strategic Outlook

Caffeine

The robust and expanding market for caffeine, fueled by consumer lifestyle trends, supports consistent revenue flows. Pharmaceutical formulations, including combination products, benefit from ongoing innovation in delivery methods and dosing strategies. The pharmaceutical segment’s projected CAGR of over 4% indicates steady growth, with opportunities in developing markets where caffeine consumption surges.

Emerging trends such as caffeine in medical devices, transdermal patches, and novel delivery systems could open additional revenue streams. Moreover, the integration of caffeine into personalized medicine frameworks, considering pharmacogenomic profiles, offers long-term growth potential.

Ergotamine Tartrate

By contrast, ergotamine tartrate faces a muted growth trajectory, constrained by safety issues, diminishing clinical use, and generic commoditization. Its projected CAGR of approximately 2% underscores a market primarily sustained by existing demand rather than expansion.

Future revenue is likely limited unless new formulations improve safety profiles, or it finds repositioning within alternative therapeutic niches that leverage its vasoconstrictive properties. However, regulatory hurdles and competition from triptans and CGRP antagonists place significant cap on upside potential.


Implications for Stakeholders

  • Pharmaceutical Companies: Investment in caffeine formulations aligned with consumer health trends offers promising returns; however, ergotamine’s limited growth diminishes opportunities for significant market expansion.
  • Investors: Diversification into caffeine-related product lines appears more lucrative; ergotamine markets warrant cautious positioning, primarily in mature and stable segments.
  • Regulatory Bodies: Ongoing safety assessments, particularly for caffeine in high doses and ergotamine’s vasoconstrictive effects, will continuously influence market dynamics.
  • R&D Entities: Focused research on innovative delivery methods for caffeine and safety-enhanced formulations of existing drugs could unlock new revenue streams.

Key Takeaways

  • The caffeine market remains dynamic, with a steady CAGR driven by consumer health trends, functional foods, and pharmaceutical innovations. Opportunities in personalized and delivery system innovations support long-term growth.
  • The ergotamine tartrate market is characterized by slow growth, constrained by safety concerns, patent expirations, and competition from newer migraine therapies. Its future is primarily as a niche or fallback treatment.
  • Strategic investments should prioritize caffeine-based products, leveraging rising global demand and technological advancements, while maintaining cautious exposure to ergotamine’s limited prospects.
  • Regulatory vigilance remains essential, particularly concerning safety profiles and permissible dosages for both compounds.
  • Innovation, especially in formulations and delivery mechanisms, constitutes the key avenue for driving future revenue in the caffeine segment.

FAQs

1. What factors influence the growth of caffeine in pharmaceutical markets?
Market growth is driven by consumer trends toward cognitive enhancement, increasing popularity in functional foods and beverages, innovations in delivery forms, and expanding applications in OTC medications.

2. How does regulation impact ergotamine tartrate market growth?
Regulatory agencies impose strict contraindications and safety guidelines due to vasoconstrictive risks, limiting new product development and constraining market expansion.

3. Are there any recent innovations in caffeine formulations?
Yes, developments include sustained-release patches, microencapsulation for targeted delivery, and combination products with other nootropics or therapeutics, enhancing efficacy and patient compliance.

4. What is the outlook for ergotamine tartrate in the next decade?
Growth prospects are limited, as it continues to be supplanted by triptans and newer migraine therapies. Its niche use persists mainly in specific patient populations intolerant to modern options.

5. How can companies leverage market trends for future growth?
Focusing on innovative delivery systems, expanding formulations with enhanced safety profiles, and tapping into emerging markets are strategic avenues for growth in caffeine-based pharmaceuticals.


References

[1] MarketWatch, "Caffeine Market Size, Share & Trends Analysis," 2022.
[2] World Health Organization, "Migraine Fact Sheet," 2022.
[3] Grand View Research, "Global Ergotamine Tartrate Market Analysis," 2022.

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