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. Ten 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:	4,236
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
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes	8,440,631		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
Japan	2021508670	疾患の処置のための鼻腔内エピネフリン製剤及び方法
United Kingdom	202016960
Russian Federation	2554814	КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ (COMPOSITIONS FOR DRUG INTRODUCTION)
United Kingdom	202012086
Finland	C20250011

Supplementary Protection Certificates for TOSYMRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
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	C20250011	Finland
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823

Market Dynamics and Financial Trajectory for Tosymra®

Introduction to Tosymra®

Tosymra®, a sumatriptan nasal spray, is a medication developed by Tonix Pharmaceuticals for the acute treatment of migraine in adults. It has recently garnered significant attention due to its unique delivery method and the issuance of a new U.S. patent.

Patent Protection and Market Exclusivity

The issuance of U.S. Patent No. 12,090,139 for Tosymra® is a significant development, extending patent protection until 2030. This extended protection could secure market exclusivity for an additional six years, providing Tonix Pharmaceuticals with a competitive edge in the migraine treatment market[1].

Competitive Landscape

The migraine treatment market is highly competitive, with various oral triptans and other treatments available. Despite the patent protection, the success of Tosymra® will depend on its efficacy, pricing, and marketing strategies compared to existing alternatives. The faster onset of action and improved bioavailability of Tosymra® could differentiate it from oral triptans, but market penetration will be influenced by multiple factors beyond patent protection[1].

Revenue Performance

For the nine months ended September 30, 2024, Tosymra® contributed $1.5 million to Tonix Pharmaceuticals' product revenue, with $0.3 million of this coming from the third quarter of 2024. This is part of a broader product revenue picture that includes contributions from Zembrace SymTouch, another product marketed by Tonix[2].

Financial Highlights

• Product Revenue: Net product revenue for Q3 2024 was $2.822 million, with Tosymra® contributing a smaller but significant portion.
• Cost of Revenue: The cost of revenue for Q3 2024 was $1.555 million, indicating a need for efficient cost management.
• Operating Loss: Tonix Pharmaceuticals reported an operating loss of $(15.554) million for Q3 2024, reflecting ongoing expenses in research, development, and marketing[2].

Market Share and Growth Trajectory

The current market share and growth trajectory of Tosymra® are crucial for investors. While the product has shown promise, its market share is still relatively small compared to other migraine treatments. The competitive edge provided by the new patent and the product's unique delivery method could help in expanding its market share, but this will require effective marketing and pricing strategies[1].

Pricing Strategy and Reimbursement Landscape

The pricing strategy for Tosymra® will be a key factor in its market success. The reimbursement landscape, including insurance coverage and out-of-pocket costs for patients, will also influence its adoption. Effective pricing and reimbursement strategies can enhance the product's market penetration and revenue growth[1].

Marketing Capabilities and Budget

Tonix Pharmaceuticals' marketing capabilities and budget will play a significant role in promoting Tosymra®. The company's transition to a fully integrated pharmaceutical company, with Tonix Medicines handling the marketing of its products, is a step in this direction. Effective marketing efforts, aligned with the product's unique benefits, are essential for increasing market share[4].

Inventory Management and Sales Units

The company recorded a significant write-down of $2.0 million related to Tosymra and Zembrace finished goods inventory during the nine months ended September 30, 2024. This highlights the need for careful inventory management to avoid such write-downs in the future. The sales units of Tosymra® need to be aligned with projected sales to optimize revenue and minimize losses[2].

Clinical and Regulatory Aspects

Tosymra® has been indicated and marketed for the acute treatment of migraine in adults, with a 10mg dosage. The product's efficacy and side effect profile compared to competitors will be critical in determining its long-term success. Regulatory approvals and compliance will continue to be important as the product navigates the competitive market[1].

Investor Considerations

Investors should closely monitor several key factors:

• Efficacy and Side Effect Profile: How Tosymra® compares to other migraine treatments in terms of efficacy and side effects.
• Pricing and Reimbursement: The impact of pricing strategies and reimbursement policies on revenue.
• Marketing and Sales: The effectiveness of Tonix's marketing efforts and sales strategies.
• Financial Performance: The overall financial health of Tonix Pharmaceuticals, including operating losses and cash reserves[1][2].

Future Outlook

The future outlook for Tosymra® is tied to its ability to differentiate itself in a competitive market. With the extended patent protection and unique delivery method, there is potential for increased market share. However, this will depend on various factors, including the company's financial health, marketing capabilities, and the broader market dynamics.

"The migraine treatment market is highly competitive and the impact on revenue will depend on Tosymra®'s efficacy, pricing and marketing strategies compared to alternatives."[1]

Key Takeaways

• Extended Patent Protection: Tosymra® has been granted a U.S. patent extending protection until 2030.
• Competitive Edge: The product's faster onset of action and improved bioavailability could differentiate it from oral triptans.
• Revenue Performance: Tosymra® contributed $1.5 million to product revenue for the nine months ended September 30, 2024.
• Financial Health: Tonix Pharmaceuticals reported an operating loss but has been strengthening its financial position through securities offerings.
• Marketing and Sales: Effective marketing and sales strategies are crucial for increasing market share.

Frequently Asked Questions (FAQs)

Q: What is Tosymra® and how is it used?

A: Tosymra® is a sumatriptan nasal spray indicated for the acute treatment of migraine in adults.

Q: What is the significance of the new U.S. patent for Tosymra®?

A: The new patent extends protection until 2030, potentially securing market exclusivity for an additional six years and providing a competitive edge.

Q: How does Tosymra® differentiate itself in the migraine treatment market?

A: Tosymra® offers a faster onset of action and improved bioavailability compared to oral triptans.

Q: What are the key factors influencing the revenue of Tosymra®?

A: Efficacy, pricing, marketing strategies, and reimbursement landscape are critical factors influencing revenue.

Q: What is the current financial performance of Tonix Pharmaceuticals related to Tosymra®?

A: For the nine months ended September 30, 2024, Tosymra® contributed $1.5 million to product revenue, and the company reported an operating loss but has been strengthening its financial position.

Sources:

1. Stocktitan.net - Tonix Pharmaceuticals Announces Issuance of U.S. Patent by the United States Patent and Trademark Office for Tosymra®.
2. TradingView - Tonix Pharmaceuticals Holding Corp. SEC 10-Q Report.
3. Stocktitan.net - Tonix Pharmaceuticals Announces Key Findings from Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya™.
4. Biospace - Tonix Pharmaceuticals Announces Transition to Fully Integrated Biopharmaceutical Company.
5. Biospace - Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights.

Last updated: 2024-12-17