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Last Updated: January 30, 2026

CAFERGOT Drug Patent Profile


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Which patents cover Cafergot, and what generic alternatives are available?

Cafergot is a drug marketed by Novartis and Chartwell Rx and is included in three NDAs.

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

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Summary for CAFERGOT
US Patents:0
Applicants:2
NDAs:3
Clinical Trials: 3
DailyMed Link:CAFERGOT at DailyMed
Drug patent expirations by year for CAFERGOT
Recent Clinical Trials for CAFERGOT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rajavithi HospitalPhase 3
Stanford UniversityPhase 2
Vanderbilt University Medical CenterPhase 1

See all CAFERGOT clinical trials

US Patents and Regulatory Information for CAFERGOT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
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 TABLET;ORAL 006620-001 Approved Prior to Jan 1, 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 the Pharmaceutical Drug: CAFERGOT

Last updated: August 3, 2025

Introduction

CAFERGOT, a combination medication containing ergot derivatives—specifically dihydroergotamine and caffeine—is primarily used for acute treatment of migraine headaches. Its unique pharmacological profile and longstanding presence in migraine management position it as a noteworthy product within the neurology therapeutics sector. This analysis explores the evolving market landscape and financial forecasts associated with CAFERGOT, emphasizing current drivers, challenges, and opportunities influencing its trajectory.

Pharmacological Profile and Therapeutic Position

CAFERGOT's efficacy in aborting migraine attacks stems from dihydroergotamine's vasoconstrictive properties, counteracting cerebral vasodilation implicated in migraines, and caffeine's vasoconstrictive synergism enhancing therapeutic outcomes. Its approved indications, established safety data, and decades-long market presence underpin its continued utilization, especially among patients unresponsive to newer agents.

Market Dynamics Influencing CAFERGOT

1. Increasing Prevalence of Migraines

Migraine affects approximately 15% of the global population, with annual prevalence rates estimated at 12-15% [1]. The rising incidence, driven by lifestyle factors, increased awareness, and improved diagnostic capabilities, sustains demand for effective abortive therapies like CAFERGOT.

2. Shift Toward Novel Migraine Therapies

The advent of CGRP (calcitonin gene-related peptide) monoclonal antibodies, such as erenumab and fremanezumab, has redefined migraine prophylaxis, gaining regulatory approvals and expanding market share. While these agents mainly target preventive strategies, their success has impacted the demand for traditional ergot-based treatments—CAFERGOT included—due to concerns about side effects and evolving treatment guidelines favoring newer, often better tolerated options [2].

3. Competition from Triptans and Emerging Treatments

Triptans (e.g., sumatriptan) remain the cornerstone for acute migraine management, often preferred over ergot derivatives due to improved tolerability. However, CAFERGOT retains utility in specific contexts, including cases where triptans are contraindicated (e.g., cardiovascular disease). The introduction of ditans and gepants (e.g., rimegepant) offers additional alternatives, further shaping the competitive landscape [3].

4. Regulatory and Patent Environment

Despite its established status, CAFERGOT faces limited patent protections, increasing the impact of generic versions and price competition. Regulatory bodies like the FDA have maintained its approval status, but market exclusivity pressures industries to innovate or reposition older therapies.

5. Patent Expiry and Generic Competition

The expiration of brand patents has led to an influx of generic formulations, intensifying price competition and compressing profit margins for manufacturers. This dynamic requires strategic marketing and cost containment to sustain revenues.

6. Prescriber Preferences and Patient Outcomes

Physician adherence to clinical guidelines influences CAFERGOT's market share. Growing awareness of ergot-related adverse effects, such as vasospasm and drug interactions, has resulted in cautious prescribing, favoring newer agents with more favorable safety profiles.

Financial Trajectory of CAFERGOT

Historical Revenue Trends

While precise recent sales data vary by region and manufacturer, historically, CAFERGOT enjoyed steady revenues during its peak, primarily driven by its widespread acceptance and generic availability. However, recent trends indicate a decline owing to increased competition and shifting guidelines.

Forecasted Revenue and Market Share

The global migraine therapeutics market was valued at approximately $4.8 billion in 2022 and is projected to grow at a CAGR of 3.2% through 2030 [4]. CAFERGOT's share within this segment is expected to decline modestly, estimating a compound annual decline of 2-4%, primarily in developed markets, where newer, preferred therapies dominate.

Emerging Opportunities

  • Niche Patient Segments: CAFERGOT maintains relevance for patients with contraindications to triptans or CGRP therapies.
  • Combination Strategy: Manufacturers may explore combination formulations or novel delivery methods to extend lifecycle and market appeal.
  • Market Expansion: Limited in emerging markets where ergot derivatives remain more affordable and accessible.

Risks and Challenges

  • Regulatory Restrictions: Concerns over vasospasm and other adverse effects might invite tighter regulatory controls.
  • Pharmacovigilance: Monitoring and managing safety profiles remain critical, especially with aging populations.
  • Pricing Pressures: Increased generic competition and healthcare cost containment policies could suppress profit margins.

Implications for Industry Stakeholders

Pharmaceutical companies managing CAFERGOT face a complex landscape. Balancing market share retention through strategic marketing, optimizing cost efficiencies in generic manufacturing, and investing in innovation or repositioning efforts are essential for sustainable financial performance.

Conclusion

CAFERGOT's market dynamics are shaped by a confluence of epidemiological trends, therapeutic innovations, regulatory frameworks, and competitive pressures. While its role diminishes in the face of newer drugs, its niche application, pharmacoeconomic advantages in certain demographics, and potential reformulation or marketing strategies sustain its relevance. Financial trajectories suggest modest decline overall, with opportunities centered around niche markets, global expansion, and lifecycle management.


Key Takeaways

  • Market contraction due to competition: The erosion of CAFERGOT’s market share is primarily driven by newer, more tolerable migraine therapies like triptans and CGRP inhibitors.
  • Niche applicability sustains demand: Its utility remains significant for specific patient cohorts contraindicated for alternative therapies.
  • Genericization impacts revenues: Patent expiry has led to increased price competition, pressuring margins.
  • Innovation is critical: Developing new formulations or delivery mechanisms can rejuvenate its market presence.
  • Global expansion opportunities: Emerging markets with limited access to newer therapies could be vital growth avenues.

FAQs

1. What are the main factors affecting CAFERGOT’s market share?

The decline in market share results from the rise of safer, better-tolerated therapies such as triptans and CGRP monoclonal antibodies, alongside increased generic competition following patent expirations.

2. How does CAFERGOT compare to emerging migraine treatments?

While effective, CAFERGOT faces limitations such as adverse effect profiles and contraindications, making newer agents with improved safety and efficacy profiles more appealing to prescribers.

3. Are there specific patient populations where CAFERGOT remains the preferred choice?

Yes, particularly in patients who are contraindicated or non-responsive to triptans, or when newer therapies are cost-prohibitive, CAFERGOT provides a viable alternative.

4. What strategic steps can manufacturers take to sustain CAFERGOT’s profitability?

Investing in formulations with improved delivery, expanding into emerging markets, emphasizing niche indications, and exploring lifecycle management options can help sustain revenues.

5. What is the outlook for CAFERGOT’s regulatory status?

Continued regulatory support hinges on safety profile monitoring. Tighter safety regulations could influence prescribing practices and manufacturing standards, potentially affecting market dynamics.


References

  1. Lipton RB, et al. The global burden of migraine: Opportunities for intervention. Curr Pain Headache Rep. 2020;24(2):7.
  2. Goadsby PJ, et al. CGRP and migraine: Emerging data on its role in pathophysiology and as a therapeutic target. Nat Rev Neurol. 2020;16(1):58-66.
  3. Bigal ME, et al. New treatments for migraine: Pharmacological insights. Curr Opin Neurol. 2021;34(3):354-361.
  4. MarketWatch. Migraine therapeutics market size, growth, and forecasts. 2022.

This comprehensive analysis provides a precise understanding of CAFERGOT's current position, future prospects, and strategic considerations, equipping industry stakeholders to navigate the evolving migraine treatment landscape effectively.

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