dihydroergotamine mesylate - Profile

What are the generic sources for dihydroergotamine mesylate and what is the scope of freedom to operate?

Dihydroergotamine mesylate is the generic ingredient in seven branded drugs marketed by Bausch, Baxter Hlthcare Corp, Cipla, Gland, Hikma, Hikma Pharms, Milla Pharms, Padagis Us, Sagent Pharms Inc, Satsuma Pharms, Amneal, Rubicon Research, Somerset Theraps Llc, Impel Pharms, and Novartis, and is included in nineteen NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dihydroergotamine mesylate has one hundred and seven patent family members in eighteen countries.

Summary for dihydroergotamine mesylate

International Patents:	107
US Patents:	17
Tradenames:	7
Applicants:	15
NDAs:	19

US Patents and Regulatory Information for dihydroergotamine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	D.H.E. 45	dihydroergotamine mesylate	INJECTABLE;INJECTION	005929-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Baxter Hlthcare Corp	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	216747-001	Jan 7, 2025		DISCN	No	No
Cipla	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	212334-001	Sep 20, 2024		DISCN	No	No
Gland	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	215623-001	Aug 18, 2023	AP	RX	No	No

Expired US Patents for dihydroergotamine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997

International Patents for dihydroergotamine mesylate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2020114620
European Patent Office	4008307	FORMULATION INTRANASALE À BASE DE DHE POUR LE TRAITEMENT DES MAUX DE TÊTE (INTRANASAL DHE FORMULATION FOR THE TREATMENT OF HEADACHE)
Russian Federation	2019105698
Spain	2937440

Investment Scenario and Fundamentals Analysis for Dihydroergotamine Mesylate

Last updated: February 20, 2026

What is Dihydroergotamine Mesylate?

Dihydroergotamine mesylate (DHE) is a semisynthetic ergot alkaloid used primarily for treating acute migraines and cluster headaches. It acts as a serotonin receptor agonist with vasoconstrictive properties. Its therapeutic use dates back to the 1940s, making it a well-established compound in headache management.

Market Overview

The global migraine drug market was valued at approximately USD 4.7 billion in 2022, with compounded annual growth rate (CAGR) estimates of 4-6% through 2030[1]. DHE's market share has declined due to the introduction of triptans; however, it retains niche status for patients who do not respond to or tolerate triptans.

Key Market Drivers

• Unmet Medical Needs: DHE remains essential for patients contraindicated for triptans, especially those with cardiovascular risks.
• Generics and Pricing: Multiple generics available since patent expiration in the mid-2000s have pressured prices but increased accessibility.
• Emerging Markets: Growing healthcare infrastructure and awareness in Asia-Pacific and Latin America present expansion opportunities.

Market Challenges

• Competition: Triptans like sumatriptan command larger market share due to better tolerability.
• Administration Route: Intranasal formulations and injection methods limit outpatient convenience, affecting preference.
• Regulatory Environment: US FDA and EMA approval processes favor newer agents with improved profiles, restricting new DHE formulations.

Regulatory and Patent Landscape

DHE formulations have been off patent since the 2000s. No significant new patents are active for DHE itself; however, formulation patents related to delivery systems (e.g., nasal sprays) or combination therapies may exist.

Regulatory Considerations

• FDA Status: Approved since 1947; recent approval for nasal spray formulations in 2004.
• European Union: Market authorization since the 1950s.
• Companion Devices: Requires regulatory approval for delivery devices, impacting market entry strategies.

Commercial and Manufacturing Fundamentals

Manufacturing Base

• Established manufacturing processes are widely available.
• Production involves fermentation-derived ergot alkaloids or chemical synthesis.
• Quality control standards align with global Good Manufacturing Practice (GMP) regulations.

Supply Chain

• Raw materials: Natural derivatives and chemical precursors are sourced globally.
• Distribution channels: Hospitals, specialty clinics, and online pharmacies dominate.

Price and Reimbursement

• Price points vary significantly across geographies; US retail price for DHE injection averages USD 50-70 per dose.
• Reimbursement policies favor established treatments; newer formulations often command higher coverage.

Investment Considerations

Opportunities

• Niche Market Position: Strong utility in specific patient subsets ensures sustained demand.
• Formulation Innovation: Developing more convenient delivery methods (e.g., auto-injectors, nasal powders) could expand market share.
• Emerging Markets: Increased healthcare access creates growth opportunities.

Risks

• Market Decline: The dominance of triptans and newer drugs may continue to diminish DHE's market share.
• Regulatory Shifts: New safety or efficacy guidelines could restrict existing use.
• Pricing Pressure: Generics intensify price competition, limiting margins.

Competitive Landscape

Competitors	Product	Status	Key Differentiator
Novartis (Imitrex)	Sumatriptan	Market leader	Oral and injectable options
Allergan (Zomig)	Zolmitriptan	Popular triptan	Nasal and tablet formulations
Teva, Mylan	Generic DHE	Available	Cost-effective options

Financial Impact

• Existing products generate modest revenues, estimated at USD 100-200 million globally.
• Investment in formulation improvements could regain market share, but returns are uncertain given competitive dynamics.

SWOT Analysis

Strengths	Weaknesses
Long-standing efficacy	Outdated delivery methods
Multiple generic options	Declined market share since triptans rise
Established manufacturing base	Limited innovation pipeline

Opportunities	Threats
New formulations or delivery systems	Competition from triptans and CGRP inhibitors
Expansion into emerging markets	Regulatory hurdles

Key Takeaways

Dihydroergotamine mesylate is a mature, off-patent drug with limited growth prospects but steady niche demand. Investment hinges on innovations in delivery, targeting unmet needs, or geographic expansion. The evolving migraine market favors newer agents with better tolerability, challenging DHE's long-term position.

FAQs

1. Is Dihydroergotamine Mesylate a viable investment for primary migraine treatment?
   Its share is declining due to competition from triptans and CGRP inhibitors; it remains relevant only for specific patient subsets.

2. Can innovation in delivery methods restore market share?
   Yes, development of non-invasive, user-friendly formulations could enhance appeal, but regulatory approval is required.

3. What is the regulatory outlook for DHE formulations?
   Existing approvals are stable; future changes depend on safety profile updates and new formulations' approval.

4. How does the competitive landscape impact profitability?
   Heavy generic presence limits pricing power and margins, supporting volume over premium pricing.

5. Are emerging markets promising for DHE?
   Increased healthcare access and awareness create growth potential, but require tailored formulations and pricing strategies.

Citations

[1] MarketsandMarkets. (2022). Migraine Drugs Market by Type, Route of Administration, Distribution Channel, and Region.