MIGRANAL Drug Patent Profile

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

Migranal is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in MIGRANAL is dihydroergotamine mesylate. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Migranal

A generic version of MIGRANAL was approved as dihydroergotamine mesylate by PADAGIS US on April 28^th, 2003.

Summary for MIGRANAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	3
Patent Applications:	1,302
Drug Prices:	Drug price information for MIGRANAL
What excipients (inactive ingredients) are in MIGRANAL?	MIGRANAL excipients list
DailyMed Link:	MIGRANAL at DailyMed

See drug prices for MIGRANAL

Recent Clinical Trials for MIGRANAL

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

Sponsor	Phase
Impel NeuroPharma Inc.	Phase 1
Stanford University	Phase 2
Thomas Jefferson University	Phase 4

See all MIGRANAL clinical trials

Pharmacology for MIGRANAL

Drug Class

Ergotamine Derivative

US Patents and Regulatory Information for MIGRANAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	AB	RX	Yes	Yes

Expired US Patents for MIGRANAL

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 MIGRANAL

See the table below for patents covering MIGRANAL around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	192325
Spain	464275
Spain	8502865
Belgium	895750
Greece	81320
Denmark	499477
Australia	520754

MIGRANAL Market Analysis and Financial Projection Experimental

Migranal: Market Dynamics and Financial Trajectory

Introduction to Migranal

Migranal, also known as dihydroergotamine mesylate, is a medication used for the acute treatment of migraine headaches. It is available in various forms, including a nasal spray, which has been a focus of recent clinical studies and market analysis.

Market Size and Growth

The migraine drugs market, within which Migranal operates, is experiencing significant growth. Here are some key financial projections:

• The migraine drugs market size was valued at $4.2 billion in 2023 and is expected to reach $6.3 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.3% during 2024-2032[1].
• Another report indicates that the market was valued at $5 billion in 2023 and is estimated to reach $5.38 billion in 2024, with a CAGR of 7.5%. By 2028, the market is projected to reach $6.84 billion at a CAGR of 6.2%[4].

Drivers of Market Growth

Several factors are driving the growth of the migraine drugs market, including:

Advancements in Novel Therapies

The introduction of new and innovative treatments, such as CGRP inhibitors like Aimovig and Emgality, has significantly impacted the market. These therapies target the calcitonin gene-related peptide to reduce migraine frequency, contributing to the market's expansion[1].

Increasing Prevalence of Migraines

The rising prevalence of migraines among the population is another key driver. As more people seek effective treatments, the demand for medications like Migranal increases.

Evolving Healthcare Practices

Improvements in healthcare practices and the adoption of more effective treatment modalities are also propelling the market forward[4].

Migranal's Role in the Market

Efficacy and Clinical Use

Migranal (dihydroergotamine mesylate) Nasal Spray has shown significant efficacy in clinical trials. Studies have demonstrated that patients receiving Migranal had a higher percentage of headache response compared to those receiving a placebo. For example, in studies 1 and 2, 70% of patients treated with Migranal achieved headache response 4 hours after treatment, compared to 28% in the placebo group[5].

Dosage and Administration

The medication is administered via a nasal spray, with a recommended dose of 0.5 mg in each nostril, repeated in 15 minutes if necessary. This dosing regimen has been shown to be effective without the need for higher doses[5].

Market Dynamics

Competitive Landscape

The migraine therapeutics market is highly competitive, with various medications and treatment options available. Migranal competes with other acute and preventive treatments, including CGRP inhibitors, antihypertensives, and other ergot alkaloids.

Regulatory Environment

The use of Migranal is subject to regulatory guidelines, particularly regarding cardiovascular safety. Patients with documented ischemic or vasospastic coronary artery disease are contraindicated from using Migranal, and periodic cardiovascular evaluations are recommended for those with risk factors[5].

Financial Projections

While specific financial projections for Migranal alone are not detailed in the available sources, the overall migraine drugs market is expected to see substantial growth. Here are some key financial milestones:

• 2023: The migraine drugs market was valued at $4.2 billion[1] or $5 billion[4].
• 2024: Projected to reach $5.38 billion[4].
• 2028: Expected to reach $6.84 billion at a CAGR of 6.2%[4].
• 2032: Projected to reach $6.3 billion at a CAGR of 4.3%[1].

Challenges and Opportunities

Challenges

• Cardiovascular Risks: Migranal's use is associated with potential cardiovascular risks, which can limit its adoption in certain patient populations[5].
• Competition: The market is highly competitive, with numerous treatment options available, which can impact Migranal's market share.

Opportunities

• Increasing Demand: The growing prevalence of migraines and the need for effective treatments present a significant opportunity for Migranal and other migraine medications.
• Advancements in Treatment: Continued advancements in treatment modalities and the development of new therapies can further drive market growth.

Key Takeaways

• The migraine drugs market, including Migranal, is expected to grow significantly due to advancements in novel therapies and increasing prevalence of migraines.
• Migranal has shown efficacy in clinical trials and is a viable treatment option for acute migraine attacks.
• The market is competitive, and regulatory considerations, especially regarding cardiovascular safety, are crucial.
• Financial projections indicate a robust growth trajectory for the migraine drugs market through 2032.

FAQs

1. What is Migranal used for? Migranal (dihydroergotamine mesylate) is used for the acute treatment of migraine headaches.

2. How is Migranal administered? Migranal is administered via a nasal spray, with a recommended dose of 0.5 mg in each nostril, repeated in 15 minutes if necessary[5].

3. What are the potential cardiovascular risks associated with Migranal? Migranal should not be used by patients with documented ischemic or vasospastic coronary artery disease due to potential cardiovascular risks, including myocardial infarction and other adverse cardiac events[5].

4. How does Migranal compare to other migraine treatments? Migranal competes with other acute and preventive treatments, including CGRP inhibitors and antihypertensives. Its efficacy and safety profile make it a viable option for some patients.

5. What are the projected growth rates for the migraine drugs market? The migraine drugs market is expected to grow at a CAGR of 4.3% from 2024 to 2032, reaching $6.3 billion by 2032[1], and at a CAGR of 6.2% from 2024 to 2028, reaching $6.84 billion by 2028[4].

Sources

1. Biospace: Migraine Drugs Market Size to Reach USD 6.3 Billion by 2032 ...
2. Mayo Clinic Proceedings: Pharmacotherapies for Migraine and Translating Evidence From ...
3. Market Research Intellect: Migraine Therapeutics Market Size, Scope And Forecast Report
4. GlobeNewswire: Migraine Drugs Market Continues To Surge At A Rate Of More
5. FDA: Migranal® (dihydroergotamine mesylate) Nasal Spray[5]