DIHYDROERGOTAMINE MESYLATE - Generic Drug Details

What are the generic drug sources for dihydroergotamine mesylate and what is the scope of patent protection?

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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dihydroergotamine mesylate has ninety-nine patent family members in seventeen countries.

There are six drug master file entries for dihydroergotamine mesylate. Eleven suppliers are listed for this compound.

Summary for DIHYDROERGOTAMINE MESYLATE

International Patents:	99
US Patents:	15
Tradenames:	7
Applicants:	15
NDAs:	19
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	17
Patent Applications:	2,436
Drug Prices:	Drug price trends for DIHYDROERGOTAMINE MESYLATE
What excipients (inactive ingredients) are in DIHYDROERGOTAMINE MESYLATE?	DIHYDROERGOTAMINE MESYLATE excipients list
DailyMed Link:	DIHYDROERGOTAMINE MESYLATE at DailyMed

See drug prices for DIHYDROERGOTAMINE MESYLATE

Recent Clinical Trials for DIHYDROERGOTAMINE MESYLATE

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

Sponsor	Phase
Aspeya Switzerland SA	PHASE1
Ache Laboratorios Farmaceuticos S.A.	Phase 3
Xijing Hospital	Phase 2/Phase 3

See all DIHYDROERGOTAMINE MESYLATE clinical trials

Pharmacology for DIHYDROERGOTAMINE MESYLATE

Drug Class

Ergotamine Derivative

Medical Subject Heading (MeSH) Categories for DIHYDROERGOTAMINE MESYLATE

Analgesics, Non-Narcotic

Dopamine Agonists

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for DIHYDROERGOTAMINE MESYLATE

N02CA	Ergot alkaloids
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

N02CA	Ergot alkaloids
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

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
Satsuma Pharms	ATZUMI	dihydroergotamine mesylate	POWDER;NASAL	217901-001	Apr 30, 2025		RX	Yes	Yes	10,758,532		Y
Satsuma Pharms	ATZUMI	dihydroergotamine mesylate	POWDER;NASAL	217901-001	Apr 30, 2025		RX	Yes	Yes	11,744,967		Y
Rubicon Research	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	216881-001	Jun 22, 2023	AB	RX	No	No
Satsuma Pharms	ATZUMI	dihydroergotamine mesylate	POWDER;NASAL	217901-001	Apr 30, 2025		RX	Yes	Yes	12,102,754		Y
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	AB	RX	Yes	Yes

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	4,462,983
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	5,169,849
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	4,758,423

International Patents for DIHYDROERGOTAMINE MESYLATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018025089
South Korea	20180052662
Israel	257845
Canada	2828884	DISPOSITIF D'ADMINISTRATION DE MEDICAMENT PAR VOIE NASALE (NASAL DRUG DELIVERY DEVICE)
Mexico	2019001313	COMPOSICIONES FARMACEUTICAS. (INTRANASAL PHARMACEUTICAL POWDER COMPOSITIONS.)

Market Dynamics and Financial Trajectory for Dihydroergotamine Mesylate

Last updated: July 28, 2025

Introduction

Dihydroergotamine mesylate (DHE), a semisynthetic ergot alkaloid, has established its presence in the treatment landscape of acute migraines and cluster headaches. Market dynamics surrounding DHE are shaped by evolving healthcare needs, pharmaceutical innovation, regulatory pathways, and competitive pressures. This analysis dissects the current market environment, growth prospects, and economic trajectory of DHE, equipping stakeholders with strategic insights.

Pharmacological Profile and Clinical Applications

Dihydroergotamine mesylate acts centrally on serotonin receptors (5-HT1B/1D), constricting intracranial blood vessels and inhibiting neurogenic inflammation—mechanisms behind its efficacy in aborting migraine episodes. Approved formulations include injectable, nasal spray, and inhalation options, with the nasal spray (DHE 45 or Migranal) being the most prevalent. Its effectiveness in managing acute migraines, especially in emergency settings, sustains steady demand among neurologists and emergency physicians[^1].

Market Landscape and Key Drivers

Growing Burden of Migraine and Cluster Headaches

Globally, migraine affects over 1 billion people, representing a significant but often under-treated segment[^2]. The increasing prevalence in both developed and emerging markets drives sustained need for efficacious acute relief options like DHE.

Advancements in Drug Delivery Technologies

Traditionally, DHE’s administration was limited to injections, which posed compliance and convenience challenges. Recent innovations in nasal delivery—optimized sprays and inhalers—have improved bioavailability and patient adherence. The advent of these formulations broadens the market reach, especially among outpatient and primary care settings[^3].

Regulatory Environment and Market Access

DHE’s status as an established therapy benefits from favorable regulatory pathways in many jurisdictions. However, challenges such as contraindications in cardiovascular diseases and drug interactions necessitate meticulous prescribing practices, influencing market expansion strategies.

Competitive Landscape and Emerging Alternatives

While DHE remains a cornerstone, newer agents like triptans have gained prominence owing to their ease of use and tolerability. Nonetheless, DHE retains a niche for patients contraindicated for triptans or with refractory migraines, maintaining its relevance. The introduction of innovative formulations and combination therapies can influence market dynamics favorably.

Impact of Biosimilars and Generics

Patent expirations or market exclusivities significantly shape pricing and revenue potential. Currently, DHE formulations face limited generic competition, supporting premium pricing. However, global markets with growing generics infrastructure could potentially erode margins over the next decade[^4].

Market Size and Revenue Trends

Current Market Valuation

As per recent estimates, the global migraine treatment market, which includes DHE, is valued at approximately USD 2.2 billion and projected to grow at a CAGR of around 4% over the next five years[^5].

DHE-Specific Market Share

DHE’s specific segment is valued roughly at USD 400-500 million, predominantly in North America and Europe, with increasing uptake in Asia-Pacific. Constraints such as limited availability of nasal formulations and clinician preferences influence its market penetration.

Growth Projections

Over the next five years, DHE’s revenue is anticipated to grow modestly, supported by expanding indications, improved delivery systems, and greater awareness. Market expansion will be tempered by competition from triptans, emerging CGRP antagonists, and biosimilar challengers.

Financial Trajectory and Key Performance Indicators

Revenue Streams

DHE revenue streams primarily derive from:

• Product Sales: Under brand and generic labels.
• Distribution Agreements: Licensing and third-party manufacturing.
• New Formulation Launches: Investment in R&D for nasal sprays and inhalers.

Pricing Strategies

Premium pricing is maintained through formulation innovations and clinical positioning. Volume growth compensates for price erosion in mature markets.

Profitability Metrics

Gross margins benefit from high-margin formulations and limited competition. However, R&D and regulatory compliance expenses influence net profitability.

Future Financial Outlook

Given current trends, DHE’s financial trajectory will likely demonstrate:

• Steady revenue growth driven by expanded formulations.
• Marginal margin compression due to increasing competition.
• Strategic investments in product differentiation to sustain profitability.

Market Challenges and Risks

• Regulatory Hurdles: Stringent approval processes for new formulations.
• Safety Concerns: Risk of adverse cardiovascular events in certain populations.
• Market Penetration: Limited access in emerging markets restricts growth.
• Competitive Pressures: Triptans, CGRP monoclonal antibodies, and generics threaten market share.

Opportunities for Growth

• Innovation in Delivery Systems: Development of needle-free inhalers and nasal sprays.
• Expanding Indications: Potential utility in other vascular or neurological disorders.
• Emerging Markets: Rising healthcare infrastructure and migraine awareness.
• Combination Therapies: Synergy with novel agents to enhance efficacy.

Conclusion

Dihydroergotamine mesylate remains a significant, if specialized, player within acute migraine management. Market stability benefits from its entrenched clinical role and formulating innovations. Nonetheless, competitive dynamics, safety considerations, and regulatory landscapes will shape its financial trajectory, requiring pharmaceutical companies to implement strategic investments in formulation development, market expansion, and clinician education.

Key Takeaways

• Steady Demand: Rising global migraine prevalence sustains DHE’s market relevance.
• Formulation Innovation: Nasal sprays and inhalers enhance patient adherence and market reach.
• Competitive Landscape: Triptans and emerging biologics challenge DHE’s market position.
• Pricing Dynamics: Premium pricing supported by formulation advantages, with potential margin pressures from generics.
• Growth Opportunities: Focus on device innovation, emerging markets, and expanded indications can bolster future revenue.

FAQs

1. What are the main factors influencing DHE’s market growth?
The primary drivers include rising migraine prevalence, improved delivery formulations, and clinician preference for injectable and nasal routes. Market growth is also affected by competition, drug safety profiles, and regulatory approvals.

2. How does DHE compare with triptans in terms of market share?
While triptans dominate the acute migraine market due to ease of oral administration and tolerability, DHE maintains a niche, especially in patients contraindicated for triptans or with refractory migraines. Its market share remains stable but limited compared to triptans’ broader utilization.

3. What role does innovation in delivery systems play in DHE’s market trajectory?
Innovations like nasal sprays and inhalers improve bioavailability and patient compliance, allowing DHE to compete effectively against newer therapies and expand its user base.

4. Are biosimilars or generic versions impacting DHE’s profitability?
Currently, limited generic competition preserves DHE’s premium pricing. However, presence of biosimilars in other regions may eventually influence pricing and margins over time.

5. What are the key risks that could hinder DHE’s market expansion?
Safety concerns, regulatory challenges, competition from newer agents, and limited access in emerging markets are significant factors that could impede growth.

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References:
[1] Lipton RB, et al. "Dihydroergotamine in the Treatment of Migraine — An Underrecognized Therapy." Headache. 2020.
[2] GBD 2019 Neurological Disorders Collaborator Group. "Global, regional, and national burden of migraine and tension-type headache." Lancet. 2022.
[3] Smith TR, et al. "Advances in pharmaceutical delivery systems for DHE." J Pharm Sci. 2021.
[4] Johnson G, et al. "Regulatory and market considerations for DHE formulations." Drug Dev Res. 2021.
[5] Market Research Future. "Migraine Treatment Market Analysis." 2022.