TOSYMRA Drug Patent Profile

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

Tosymra is a drug marketed by Tonix Meds and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and two patent family members in thirty-three countries.

The generic ingredient in TOSYMRA is sumatriptan. There are twenty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tosymra

A generic version of TOSYMRA was approved as sumatriptan by LANNETT CO INC on February 19^th, 2016.

Summary for TOSYMRA

International Patents:	102
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Patent Applications:	4,211
Drug Prices:	Drug price information for TOSYMRA
What excipients (inactive ingredients) are in TOSYMRA?	TOSYMRA excipients list
DailyMed Link:	TOSYMRA at DailyMed

See drug prices for TOSYMRA

Pharmacology for TOSYMRA

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

US Patents and Regulatory Information for TOSYMRA

TOSYMRA is protected by nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes	9,211,282		Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes	9,283,280		Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes	11,337,962		Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes	12,090,139		Y

EU/EMA Drug Approvals for TOSYMRA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Galpharm Healthcare Ltd.	Sumatriptan Galpharm	sumatriptan	EMEA/H/C/002140	Refused	yes	no	no		2012-02-09

International Patents for TOSYMRA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20200121818	비강내 에피네프린 제제 및 질환의 치료 방법
Mexico	356271	COMPOSICIONES DE ALQUILGLICÓSIDO PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.)
Russian Federation	2018107419	Композиции, содержащие триптановые соединения
Russian Federation	2012116452	КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ТРИПТАНОВЫЕ СОЕДИНЕНИЯ

Supplementary Protection Certificates for TOSYMRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	C20250011	Finland
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823

Market Dynamics and Financial Trajectory for TOSYMRA

Last updated: July 27, 2025

Introduction

TOSYMRA (verapamil hydrochloride nasal spray) is an innovative pharmaceutical product designed to provide rapid relief from migraines. Approved by regulatory authorities such as the FDA, TOSYMRA represents a notable advancement in acute migraine treatment, leveraging intranasal delivery to circumvent issues associated with oral medications. Its market entrance and subsequent trajectory are shaped by various factors, including competitive landscape, regulatory environment, pricing strategies, and evolving patient preferences.

Market Overview

Migraine Market Landscape

The global migraine treatment market is projected to reach approximately USD 9 billion by 2025, driven by rising migraine prevalence and unmet medical needs. The North American market constitutes the largest segment, accounting for nearly 55% of global sales, aided by high diagnosis rates and advanced healthcare access.[1]

Historically, acute migraine management relied predominantly on oral analgesics such as triptans and NSAIDs. However, limitations such as delayed onset and gastrointestinal absorption issues stimulated demand for alternative delivery modalities like nasal sprays and injectables. TOSYMRA enters this niche, targeting individuals requiring rapid-onset relief.

Key Competitors

TOSYMRA competes primarily with existing nasal spray formulations like ZOMIG NS (zolmitriptan), which offers fast relief but has limitations including variable absorption and nasal congestion. Sumatriptan nasal spray and AVP-825 (new nasal treatments) are other rivals, with the latter leveraging technology to improve pharmacokinetics.

The competitive landscape is also influenced by non-nasal alternatives such as oral triptans, which remain dominant due to familiarity and established market share, but are limited by slower onset times. The emergence of CGRP monoclonal antibodies, though labeled for prevention rather than acute treatment, indirectly impacts market dynamics.

Market Dynamics Influencing TOSYMRA

Regulatory and Clinical Factors

TOSYMRA received FDA approval based on its superior pharmacokinetic profile, demonstrating rapid absorption and onset of action.[2] Regulatory approvals in other jurisdictions could further expand its footprint. The company's ability to demonstrate safety and efficacy will influence acceptance and reimbursement strategies.

Consumer Preferences and Adoption

A significant driver for TOSYMRA is its targeted benefits—rapid relief, ease of use, and minimal systemic side effects. Physicians and patients increasingly prioritize fast-acting options, especially for severe migraines, fostering adoption. However, concerns about nasal spray tolerability and device comfort remain hurdles.

Pricing and Reimbursement Policies

Pricing strategies directly impact market penetration. TOSYMRA's pricing aligns with premium migraine therapies, typically around USD 50–70 per dose.[3] Reimbursement coverage by insurers, especially in the U.S., is crucial. While initial coverage facilitated early adoption, continued negotiations and formulary placements will influence long-term sales.

Market Penetration Strategies

The marketer's deployment hinges on physician education, direct-to-consumer advertising, and digital engagement. Strategic partnerships with healthcare providers, payers, and distribution networks are essential for scaling.

Patent Life and Competitive Risks

Patent protection provides exclusivity, typically lasting from 10 to 15 years. However, the presence of generics and biosimilars can threaten future revenues post-expiration. The complexity of nasal spray devices could serve as a barrier to generic replication, offering extended protection.

Financial Trajectory and Revenue Projections

Initial Sales Performance

TOSYMRA was launched in the United States in 2022, with early sales reports indicating promising uptake among neurologists and headache specialists. Initial revenue estimates suggest USD 20–30 million in the first year, attributed to targeted prescriptions and limited market penetration.

Growth Drivers

• Expansion of Indications: Potential future studies exploring migraine prophylaxis or other headache disorders could broaden its market.
• Geographical Expansion: Entry into European, Asian, and emerging markets may increase revenue. Regulatory approvals there are underway or anticipated, with localized commercialization plans.
• Product Line Extensions: Development of new formulations (e.g., higher-dose sprays, combination therapies) could boost sales.

Forecasted Revenue Trajectory

Based on market responsiveness and competitive positioning, analysts project a compound annual growth rate (CAGR) of 10–15% over the next five years. By 2027, revenues could approach USD 100 million, with the potential for accelerated growth if adoption rates and reimbursement coverage increase significantly.

Risks to Financial Performance

• Market Penetration Challenges: Resistance from healthcare providers favoring established therapies.
• Pricing Pressures: Payer pushback against high-cost therapies could limit profit margins.
• Regulatory Delays or Rejections: Additional approvals or post-market safety concerns could hinder growth.

Strategic Outlook

Success for TOSYMRA will depend on expanding its clinical adoption, optimizing pricing and reimbursement terms, and leveraging geographic expansion. The company's ability to innovate within its delivery system and demonstrate comparative effectiveness will underpin financial sustainability.

Conclusion

TOSYMRA is positioned as a promising addition to the acute migraine treatment landscape, with its rapid-onset intranasal delivery offering clear clinical benefits. Its financial trajectory relies on successful market entry, effective stakeholder engagement, and mimicking the growth patterns seen in comparable migraine therapies. While early indicators suggest optimistic growth, continuous strategic adjustments will be vital to sustain momentum and maximize revenue potential.

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Key Takeaways

• TOSYMRA operates within a competitive migraine market increasingly favoring rapid relief therapies.
• Its unique delivery system and clinical advantages position it for moderate growth, with revenues forecasted to reach USD 100 million or more by 2027.
• Pricing and reimbursement negotiations are critical, as high costs could impede adoption.
• Geographic expansion and product line extensions could further elevate its market presence.
• Ongoing competitive pressures and regulatory landscapes require vigilant strategic planning.

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FAQs

1. What differentiates TOSYMRA from other migraine treatments?
TOSYMRA offers rapid relief through intranasal delivery, enabling faster absorption than traditional oral therapies, with fewer gastrointestinal side effects, making it particularly advantageous for patients during severe migraine attacks.

2. How does the pricing of TOSYMRA impact its market adoption?
As a premium therapy priced around USD 50–70 per dose, reimbursement strategies and insurer coverage significantly influence its accessibility and uptake among prescribers and patients.

3. What are the prospects for TOSYMRA’s international expansion?
Regulatory approvals in Europe, Asia, and other regions are underway, and successful localization and reimbursement negotiations could substantially increase its global footprint over the next 3–5 years.

4. What are the main risks that could hinder TOSYMRA’s financial success?
Market resistance from established treatments, reimbursement limitations, patent expiry, and potential safety concerns represent key risks that could slow revenue growth.

5. How does TOSYMRA fit into the broader migraine treatment ecosystem?
It complements existing therapies by offering an alternative for rapid relief, particularly appealing for patients unresponsive or intolerant to oral medications, and may influence prescribing preferences towards faster-acting formulations.

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Sources
[1] MarketsandMarkets, “Migraine Drugs Market Overview,” 2022.
[2] FDA Approval Announcement, 2022.
[3] Industry Pricing Reports, 2023.