CAFERGOT Drug Patent Profile

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When do Cafergot patents expire, 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. Three suppliers are listed for this compound. Additional details are available on the caffeine; ergotamine tartrate profile page.

Summary for CAFERGOT

US Patents:	0
Applicants:	2
NDAs:	3

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
Chartwell Rx	CAFERGOT	caffeine; ergotamine tartrate	TABLET;ORAL	084294-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Novartis	CAFERGOT	caffeine; ergotamine tartrate	TABLET;ORAL	006620-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment Scenario and Fundamentals Analysis for CAFERGOT (Ergotamine and Caffeine)

Last updated: February 20, 2026

What is the market landscape for CAFERGOT?

CAFERGOT, a combination drug of ergotamine and caffeine, has historically been used for acute treatment of migraines. It is a prescription medication with declining usage due to safety concerns, replaced increasingly by newer therapies.

The global migraine treatment market was valued at approximately $4.4 billion in 2022 and is projected to reach $6.2 billion by 2028, growing at a CAGR of around 6.1% (Research and Markets, 2023). However, the specific market for ergot derivatives like CAFERGOT is shrinking due to regulatory restrictions and safety profiles.

How do the product’s clinical and regulatory attributes impact investment?

Efficacy and Safety Profile

• Efficacious for acute migraines when other treatments are contraindicated or ineffective.
• Safety issues associated with ergotamine include vasospasm, hypertension, and potential for serious adverse events, especially with prolonged use or overuse.
• Regulatory agencies (FDA, EMA) have placed restrictions on ergot derivatives, classifying them as second-line therapies.

Regulatory Status

• U.S.: Limited availability; FDA classifies ergotamine as a second-line agent under black-box warning.
• EU: Similar restrictions; marketed under specific conditions, with a decreasing number of authorized prescribers.
• Global trend toward withdrawal or limited use.

Patent and Market Exclusivity

• CAFERGOT, as a generic, faces limited or no patent protection.
• Market exclusivity has long expired, opening competition from generics and other migraine therapies.

What are the current competitive dynamics?

Main Competitors

• Triptans (e.g., sumatriptan, rizatriptan): First-line therapies with better safety profiles.
• CGRP antagonists (e.g., erenumab, fremanezumab): Recently launched, targeting preventative therapy.
• Over-the-counter options and lifestyle modifications.

Market Trends

• Shift away from ergot derivatives toward triptans and CGRP inhibitors.
• Price erosion in generic ergotamine products.
• The declining prescription volume reduces revenue opportunities for CAFERGOT.

What does the clinical pipeline and R&D outlook suggest?

• Few pipeline candidates directly target the ergotamine pathway.
• No recent approvals or significant R&D investments for CAFERGOT.
• Industry focus on novel mechanisms for migraine treatment suggests limited growth prospects for ergot-based therapies.

What is the financial outlook?

• Revenue: Likely declining, aligned with decreasing prescribe rates.
• Development costs: Minimal; no significant pipeline investments.
• Market penetration: Limited, due to safety concerns and competition.
• Strategic positioning: Low, as the product phases out in favor of safer, more effective alternatives.

What regulatory and market risks exist?

Risk	Description	Impact
Regulatory restrictions	Tightening controls on ergot derivatives	Reduced market access
Safety concerns	Potential adverse events limit prescriber confidence	Sales decline
Market competition	Shift to triptans and CGRP therapies	Loss of market share
Patent expiration	Open to generic competition	Price erosion, margin squeeze

Key investment insights

• CAFERGOT’s market position diminishes as safety concerns and regulatory restrictions intensify.
• No significant pipeline or R&D efforts support future growth.
• The revenue outlook indicates a decline, making it an unattractive investment for firms seeking long-term gains.
• Opportunities are minimal outside niche indications, primarily due to competitive pressures and safety profile limitations.

Key Takeaways

• CAFERGOT faces a shrinking market driven by safety issues and regulatory restrictions.
• It competes with well-established triptans and emerging CGRP therapies.
• The product’s decline is supported by patent expiration and market erosion from generics.
• Investment in CAFERGOT carries high risk for obsolescence, with limited upside.
• Industry focus shifts toward safer, more effective migraine therapies, reducing future prospects.

FAQs

1. Is CAFERGOT still available on the market?
   Its availability is limited, primarily due to safety concerns and regulatory restrictions.

2. What are the main competitors to CAFERGOT?
   Triptans and CGRP inhibitors hold the primary market share in acute and preventive migraine treatment.

3. Are there ongoing R&D efforts to improve ergotamine-based therapies?
   No significant recent R&D investments target ergotamine, with focus shifting toward novel mechanisms.

4. What regulatory actions could further impact CAFERGOT?
   Stricter controls or black-box warnings could further limit prescribing or lead to market withdrawal.

5. Should investors consider CAFERGOT as a long-term asset?
   No, current and projected industry trends favor discontinuation of ergotamine-based therapies.

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References

[1] Research and Markets. (2023). Global migraine treatment market forecast. Retrieved from https://www.researchandmarkets.com
[2] U.S. Food and Drug Administration. (2022). Ergotamine for Migraine. Retrieved from https://www.fda.gov
[3] European Medicines Agency. (2022). Efficacy and safety of ergot derivatives. Retrieved from https://www.ema.europa.eu