Dihydroergotamine mesylate - Generic Drug Details

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

Dihydroergotamine mesylate is the generic ingredient in five branded drugs marketed by Bausch, Baxter Hlthcare Corp, Cipla, Gland, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Aggrega, Amneal, Rubicon, Impel Pharms, and Novartis, and is included in seventeen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dihydroergotamine mesylate has sixty-four patent family members in sixteen countries.

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

Summary for dihydroergotamine mesylate

International Patents:	64
US Patents:	6
Tradenames:	5
Applicants:	14
NDAs:	17
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	16
Patent Applications:	2,004
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
Ache Laboratorios Farmaceuticos S.A.	Phase 3
Xijing Hospital	Phase 2/Phase 3
Satsuma Pharmaceuticals, Inc.	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
Rubicon	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	216881-001	Jun 22, 2023	AB	RX	No	No
Aggrega	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	215228-001	Feb 26, 2025	AB	RX	No	No
Provepharm Sas	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	212046-001	Jan 7, 2020	AP	RX	No	No
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	10,940,278		Y

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	5,169,849
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	4,758,423

International Patents for dihydroergotamine mesylate

Country	Patent Number	Title	Estimated Expiration
China	107376071	用于将化合物递送到使用者的上部嗅觉区的喷嘴 (Nozzle for use in delivering a mixture of aerosol propellant and drug formulation)
Russian Federation	2728583	УСТРОЙСТВО ДЛЯ НАЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ (DEVICE FOR NASAL DRUG DELIVERY)
Japan	2014518707
Japan	6339371

Market Dynamics and Financial Trajectory for Dihydroergotamine Mesylate

Introduction to Dihydroergotamine Mesylate

Dihydroergotamine mesylate is a potent vasoconstrictor used primarily for the acute treatment of migraine headaches. It is available in various formulations, including nasal sprays such as Migranal® and Trudhesa®.

Market Overview

The dihydroergotamine mesylate market is experiencing significant growth, driven by increasing demand for effective migraine treatments. Here are some key points:

• Market Size and Growth: The global dihydroergotamine mesylate market is projected to grow substantially from 2019 to 2031, driven by the rising prevalence of migraines and the need for effective treatments[1][4].

• Competitive Landscape: The market is dominated by a few key players, including Impel Pharmaceuticals, which has seen significant traction with its product Trudhesa®. Trudhesa has captured a notable share of the branded acute migraine prescriptions market, with over 87,000 prescriptions generated since its launch[2][5].

Trudhesa®: A Key Player in the Market

Trudhesa®, developed by Impel Pharmaceuticals, is a nasal spray formulation of dihydroergotamine mesylate that has shown strong market performance.

• Prescription Volume: As of 2023, Trudhesa has generated more than 87,000 prescriptions since its launch, with a projected range of 80,000 to 110,000 prescriptions for the full year 2023[2][5].

• Market Share: Trudhesa accounts for approximately 4.7% of branded acute migraine prescriptions among its prescribers, indicating a strong market presence[5].

• Sales Force and Reimbursement: The expansion of the sales force in July 2022 has led to increased productivity and efficiency, resulting in higher prescription numbers and improved reimbursement rates. Reimbursement rates have increased to 72% in Q1 2023 from 60% in Q4 2022[5].

Financial Performance of Impel Pharmaceuticals

Impel Pharmaceuticals' financial performance is closely tied to the success of Trudhesa.

• Net Product Revenue: For the fourth quarter and full year 2022, net revenue from Trudhesa sales was $5.0 million and $12.7 million, respectively. This represents a significant increase from the corresponding periods in 2021, where revenues were $0.6 million and $0.7 million, respectively[2].

• Research and Development (R&D) Expenses: R&D expenses decreased in 2022 due to the completion of the Phase 3 STOP 301 study and the return of the new drug application fee from the FDA. However, spending on other clinical developments, such as INP105, has increased[2].

• Selling, General and Administrative (SG&A) Expenses: SG&A expenses increased in 2022, primarily due to the ramp-up in commercial, sales, and marketing activities to support the Trudhesa launch. For Q1 2023, SG&A expenses were $22.037 million, reflecting continued investment in sales and marketing[2][5].

• Net Loss: Despite the revenue growth, Impel Pharmaceuticals reported net losses of $23.0 million and $106.3 million for the fourth quarter and full year 2022, respectively. The net loss per share was $0.97 and $4.53 for the same periods[2].

Pharmacokinetics and Efficacy

Understanding the pharmacokinetics and efficacy of dihydroergotamine mesylate is crucial for its market success.

• Absorption and Distribution: The drug is 93% plasma protein bound, with a variable absorption rate due to intersubject differences and administration techniques. The major metabolite exhibits similar potency to the parent compound[3].

• Clinical Efficacy: Studies have shown that dihydroergotamine mesylate nasal spray is effective in reducing migraine headache severity. In clinical trials, a significant percentage of patients achieved headache response within 2 and 4 hours after treatment compared to placebo[3].

Market Opportunities and Challenges

The market for dihydroergotamine mesylate is not without its opportunities and challenges.

• Growing Demand: The increasing prevalence of migraines and the need for effective treatments present a significant market opportunity. The market is expected to gain substantial shares in the forecasted period[4].

• Competition: The migraine treatment market is competitive, with various other treatments available. Differentiating Trudhesa through its safety and efficacy profile is crucial for maintaining market share[5].

• Regulatory Environment: The regulatory landscape can impact the market. For example, the return of the new drug application fee from the FDA positively affected Impel Pharmaceuticals' financials in 2022[2].

Future Outlook

The future outlook for dihydroergotamine mesylate, particularly Trudhesa, is promising.

• Prescription Growth: With projected prescription numbers ranging from 80,000 to 110,000 for 2023, Trudhesa is expected to continue its strong trajectory[2][5].

• Sales Force Efficiency: The expanded and more efficient sales force is likely to drive further growth in prescriptions and revenue[5].

• Financial Stability: While Impel Pharmaceuticals is currently operating at a net loss, the increasing revenue and improving reimbursement rates suggest a path towards financial stability[2][5].

Key Takeaways

• Market Growth: The dihydroergotamine mesylate market is growing, driven by increasing demand for effective migraine treatments.
• Trudhesa Performance: Trudhesa has shown strong market performance with significant prescription volumes and market share.
• Financial Performance: Impel Pharmaceuticals' financials are improving, though the company still operates at a net loss.
• Efficacy and Pharmacokinetics: Dihydroergotamine mesylate has proven efficacy and a well-understood pharmacokinetic profile.
• Future Outlook: The future looks promising with projected growth in prescriptions and revenue.

Frequently Asked Questions (FAQs)

Q: What is dihydroergotamine mesylate used for? A: Dihydroergotamine mesylate is used for the acute treatment of migraine headaches.

Q: What is Trudhesa, and how has it performed in the market? A: Trudhesa is a nasal spray formulation of dihydroergotamine mesylate developed by Impel Pharmaceuticals. It has generated over 87,000 prescriptions since its launch and accounts for approximately 4.7% of branded acute migraine prescriptions among its prescribers.

Q: How has the sales force expansion impacted Trudhesa's performance? A: The sales force expansion in July 2022 has led to increased productivity and efficiency, resulting in higher prescription numbers and improved reimbursement rates.

Q: What are the key financial metrics for Impel Pharmaceuticals related to Trudhesa? A: For 2022, net revenue from Trudhesa sales was $12.7 million, with net losses of $106.3 million. SG&A expenses increased to support commercial activities.

Q: What is the future outlook for dihydroergotamine mesylate and Trudhesa? A: The future outlook is promising, with projected prescription growth, increased sales force efficiency, and improving financial stability.

Cited Sources

1. Cognitivemarketresearch.com: Global Dihydroergotamine Mesylate Market Report 2024 Edition.
2. Globenewswire.com: Impel Pharmaceuticals Announces Fourth Quarter and Full-Year 2022 Financial Results and Provides Business Update.
3. Accessdata.fda.gov: Migranal® (dihydroergotamine mesylate) Nasal Spray.
4. Marketresearchintellect.com: Dihydroergotamine Mesylate Market Size, Share, Trends, Scope.
5. Biospace.com: Impel Pharmaceuticals Announces First Quarter 2023 Financial Results and Provides Business Update.

Last updated: 2024-12-16