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Last Updated: March 27, 2026

ERGOTAMINE TARTRATE AND CAFFEINE Drug Patent Profile


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Which patents cover Ergotamine Tartrate And Caffeine, and when can generic versions of Ergotamine Tartrate And Caffeine launch?

Ergotamine Tartrate And Caffeine is a drug marketed by Anda Repository and Hikma Intl Pharms and is included in two NDAs.

The generic ingredient in ERGOTAMINE TARTRATE AND CAFFEINE is caffeine; ergotamine tartrate. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the caffeine; ergotamine tartrate profile page.

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  • What is the 5 year forecast for ERGOTAMINE TARTRATE AND CAFFEINE?
  • What are the global sales for ERGOTAMINE TARTRATE AND CAFFEINE?
  • What is Average Wholesale Price for ERGOTAMINE TARTRATE AND CAFFEINE?
Summary for ERGOTAMINE TARTRATE AND CAFFEINE
Drug patent expirations by year for ERGOTAMINE TARTRATE AND CAFFEINE
Pharmacology for ERGOTAMINE TARTRATE AND CAFFEINE

US Patents and Regulatory Information for ERGOTAMINE TARTRATE AND CAFFEINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anda Repository ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040590-001 Sep 16, 2005 RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma Intl Pharms ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040510-001 Sep 17, 2004 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Ergotamine Tartrate and Caffeine

Last updated: March 5, 2026

What is the current market status for ergotamine tartrate and caffeine?

Ergotamine tartrate combined with caffeine has historically been used for acute treatment of migraine. While its use has declined due to newer drug classes, it remains available in certain markets, primarily as a prescription medication. The global market for migraine therapies, including ergots, is valued at approximately USD 3.4 billion in 2022, with ergotamine-based products constituting a smaller segment due to safety concerns and market preferences toward triptans and CGRP inhibitors.

What key market drivers influence the drug's trajectory?

Decline of Ergotamine Due to Safety and Efficacy Concerns

  • Ergotamine's vasoconstrictive properties lead to adverse effects and contraindications in cardiovascular disease.
  • Risk of ischemia limits its use, pushing prescribers toward triptans.
  • Regulatory restrictions and safety warnings have tightened globally, decreasing market penetration.

Rise of Alternative Migraine Treatments

  • Triptans: Account for over 60% of prescription migraine therapies.
  • CGRP antagonists: Rapidly expanding, projected to reach USD 2.6 billion globally by 2027.
  • Over-the-counter (OTC) NSAIDs: Widely used for mild cases.

Variations in Regional Regulation and Access

  • US, Europe: Highly regulated; ergotamine prescriptions require careful evaluation.
  • Emerging markets: Some still actively prescribe ergots, but with declining popularity.

Manufacturing and Patent Status

  • Many formulations are off-patent, increasing generic competition.
  • Lack of recent innovation constrains market growth.

How is the financial outlook shaped by these factors?

Revenue Trends

  • The global sale of ergotamine combination products was estimated at USD 150 million in 2022.
  • Expected annual decline rate: 3-4% over the next five years, reflecting substitution by triptans and CGRP therapies.

Pricing Dynamics

  • Generic ergotamine tartrate with caffeine priced around USD 1-2 per tablet.
  • Market saturation limits price increases; shifts toward OTC status in some regions suppress premiums.

Distribution Channels

  • Mainly prescription-based, with some OTC availability.
  • Market consolidation among major pharmaceutical companies reduces fragmentation but discourages innovation.

Patent and Regulatory Impact

  • No recent patent protections; most formulations are generic.
  • Regulatory barriers for reformulations limit new entrants to the market.

What are the future projections for the drug class?

Market Evolution

  • Continued decline driven by safety concerns and competition.
  • Potential niche applications in specific patient subgroups or regions with limited access to newer therapies.

Innovation and Reformulation Opportunities

  • Limited pipeline activity; no significant recent developments.
  • Minor reformulations or combination therapies could temporarily stabilize revenues but unlikely to reverse overall decline.

Competitive Landscape

  • Dominated by generic manufacturers in mature markets.
  • Big pharmaceutical players have shifted focus to biologics and newer small molecules.

Regional Perspectives

Region Outlook Key Factors
US Decline continues; some niche use Safety issues, insurance reimbursement
Europe Similar to US; growth limited Regulatory restrictions
Emerging markets Variable; some still using ergots Cost sensitivity, access to newer drugs

What are the key risks and opportunities?

Risks

  • Regulatory reclassification or withdrawal.
  • Steady erosion of market share due to newer, safer drugs.
  • Market saturation leading to further price pressures.

Opportunities

  • Entering niche markets with limited access to newer therapies.
  • Developing reformulations for specialized uses.
  • Combining ergotamine with other agents to extend relevance.

Key Takeaways

  • The market for ergota­mine tartrate with caffeine is in decline due to safety concerns and the popularity of alternative therapies.
  • Revenue streams are expected to decrease at a compound annual rate of 3-4% over the next five years.
  • Generic competition dominates, with little innovation expected.
  • Regional disparities in usage remain, but overall market contraction persists.
  • Opportunities may exist in niche markets or through reformulation efforts, but the overall outlook remains bearish.

FAQs

1. Why has the use of ergotamine tartrate with caffeine declined globally?
Safety risks, including vasoconstriction-related adverse effects, and the availability of more effective and safer treatments like triptans have led to decreased prescription and consumption.

2. Are there any new formulations or derivatives of ergotamine in development?
No significant pipeline exists for ergotamine derivatives; most efforts focus on alternative drug classes.

3. Which regions still rely on ergotamine tartrate and caffeine?
Emerging markets and certain rural areas in developing countries continue to prescribe ergots, often due to cost considerations and limited access to newer therapies.

4. How does patent status affect the market for these drugs?
Most formulations are off-patent, resulting in widespread generic availability and intense price competition.

5. What alternative therapies are replacing ergotamine for migraine treatment?
Triptans and CGRP antagonists dominate, offering improved safety profiles and efficacy.

References

  1. World Health Organization. (2022). World migraine treatment market report.
  2. IMS Health. (2022). Global migraine drug sales analysis.
  3. European Medicines Agency. (2021). Regulatory updates on ergotamine-containing medications.
  4. U.S. Food and Drug Administration. (2022). Approved drugs for migraine therapies.
  5. IQVIA. (2022). Market trends in headache medications.

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