ZEMBRACE SYMTOUCH Drug Patent Profile

Which patents cover Zembrace Symtouch, and when can generic versions of Zembrace Symtouch launch?

Zembrace Symtouch is a drug marketed by Tonix Meds and is included in one NDA. There are three patents protecting this drug.

This drug has six patent family members in six countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zembrace Symtouch

A generic version of ZEMBRACE SYMTOUCH was approved as sumatriptan succinate by WEST-WARD PHARMS INT on February 6^th, 2009.

Summary for ZEMBRACE SYMTOUCH

International Patents:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	115
Patent Applications:	2,315
Drug Prices:	Drug price information for ZEMBRACE SYMTOUCH
What excipients (inactive ingredients) are in ZEMBRACE SYMTOUCH?	ZEMBRACE SYMTOUCH excipients list
DailyMed Link:	ZEMBRACE SYMTOUCH at DailyMed

See drug prices for ZEMBRACE SYMTOUCH

Pharmacology for ZEMBRACE SYMTOUCH

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 ZEMBRACE SYMTOUCH

ZEMBRACE SYMTOUCH is protected by three 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	ZEMBRACE SYMTOUCH	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	208223-001	Jan 28, 2016		RX	Yes	No
Tonix Meds	ZEMBRACE SYMTOUCH	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	208223-001	Jan 28, 2016		RX	Yes	No
Tonix Meds	ZEMBRACE SYMTOUCH	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	208223-001	Jan 28, 2016		RX	Yes	No			Y

International Patents for ZEMBRACE SYMTOUCH

See the table below for patents covering ZEMBRACE SYMTOUCH around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3331524	COMPOSITION PHARMACEUTIQUE COMPRENANT DU SUMATRIPTAN POUR LE TRAITEMENT DE LA MIGRAINE (PHARMACEUTICAL COMPOSITION COMPRISING SUMATRIPAN FOR TREATING MIGRAINE)
Mexico	2018001528	COMPOSICION FARMACEUTICA QUE COMPRENDE SUMATRIPTAN PARA TRATAMIENTO DE MIGRAÑA. (PHARMACEUTICAL COMPOSITION COMPRISING SUMATRIPAN FOR TREATING MIGRAINE.)
Brazil	112018002433	composição farmacêutica para tratamento da enxaqueca
China	107921023	用于治疗偏头痛的包含舒马曲坦的药物组合物 (Pharmaceutical composition comprising sumatripan for treating migraine)
World Intellectual Property Organization (WIPO)	2017023361
Canada	2994748	COMPOSITION PHARMACEUTIQUE COMPRENANT DU SUMATRIPTAN POUR LE TRAITEMENT DE LA MIGRAINE (PHARMACEUTICAL COMPOSITION COMPRISING SUMATRIPAN FOR TREATING MIGRAINE)

ZEMBRACE SYMTOUCH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Zembrace SymTouch

Introduction to Zembrace SymTouch

Zembrace SymTouch, a sumatriptan injection, is a key product in the treatment of acute migraine with or without aura in adults. It is the only branded sumatriptan autoinjector professionally promoted in the United States, known for its ease of use and favorable tolerability with a low 3 mg dose[4].

Acquisition by Tonix Pharmaceuticals

In July 2023, Tonix Pharmaceuticals Holding Corp. completed the acquisition of Zembrace SymTouch from Upsher-Smith Laboratories, LLC, along with another migraine treatment, Tosymra. This acquisition marked a significant step for Tonix in building its commercial capabilities and expanding its presence in the CNS disorders market[1][4].

Market Position and Competition

Zembrace SymTouch operates in a competitive market for migraine treatments, which includes other sumatriptan products such as Imitrex and its generics. However, its unique autoinjector design and professional promotion set it apart as a preferred option for some patients. The product has patent protection until 2036, providing a competitive edge in the market[1][3].

Clinical Efficacy

Clinical studies have demonstrated the efficacy of Zembrace SymTouch in providing rapid relief from migraine pain. For instance, a study showed that 51.0% of subjects were pain-free at two hours post-dose, significantly higher than the placebo group at 30.8% (P=0.0023)[1].

Financial Performance

Revenue Contribution

Since its acquisition, Zembrace SymTouch has contributed significantly to Tonix Pharmaceuticals' revenue. For the third quarter of 2024, Zembrace SymTouch generated $2.5 million in revenue, while for the nine months ended September 30, 2024, it contributed $6.1 million[2].

Cost of Revenue and Gross Margin

The cost of revenue for Zembrace SymTouch and other products has been notable. For the nine months ended September 30, 2024, the cost of revenue was $6.582 million, resulting in a product gross margin of approximately 74.5% to 75.2%[2].

Operating Loss and Net Loss

Despite the revenue generated, Tonix Pharmaceuticals has reported operating losses. For the third quarter of 2024, the operating loss was $(15.554) million, and for the nine months ended September 30, 2024, it was $(114.221) million. The net loss available to common stockholders for the same periods was $(14.213) million and $(107.928) million, respectively[2].

Strategic Impact

The acquisition of Zembrace SymTouch is part of Tonix's broader strategy to become a fully integrated pharmaceutical company. While the product itself is not seen as a primary growth driver, it serves as a stepping stone for Tonix to expand its commercial operations and advance its development pipeline, including the potential launch of TNX-102 SL for fibromyalgia[1].

Future Outlook

Tonix Pharmaceuticals is anticipating several key milestones that could impact the financial trajectory of Zembrace SymTouch. These include the potential FDA approval of TNX-102 SL in 2025 and the initiation of enrollment in the OASIS study for TNX-102 SL in Q4 2024. The company also plans to continue expanding the market opportunity for both Zembrace and Tosymra[2].

Operational Challenges

Tonix has faced significant operational challenges, including a sustained decline in revenues and delays in building out the sales team for its commercialized products. This has led to a full impairment of its Zembrace and Tosymra developed technology intangible assets. The company also relies heavily on third parties for research and development, manufacturing, and other critical operations, which poses additional risks[2].

Market Risks and Dependencies

The company is exposed to various market risks, including changes in market conditions, competition, and economic factors. Additionally, the dependence on third parties for critical operations could adversely affect the business. These factors could impact the financial performance and stability of Tonix Pharmaceuticals and, by extension, the market dynamics of Zembrace SymTouch[2].

Capital Raising and Funding

To support its operations and expansion plans, Tonix Pharmaceuticals has engaged in capital-raising activities. For example, the company raised $6.2 million in net proceeds from a public offering in August 2023. Such funding is crucial for advancing clinical development programs and maintaining the commercial viability of products like Zembrace SymTouch[4].

Key Takeaways

• Acquisition and Integration: Tonix Pharmaceuticals acquired Zembrace SymTouch to build its commercial capabilities and expand its CNS disorders portfolio.
• Revenue Contribution: Zembrace SymTouch has generated significant revenue for Tonix, with $6.1 million in the nine months ended September 30, 2024.
• Clinical Efficacy: The product has demonstrated rapid and effective relief from migraine pain in clinical studies.
• Operational Challenges: Tonix faces challenges such as declining revenues and delays in sales team development.
• Future Outlook: The company is focused on advancing its development pipeline and expanding market opportunities for Zembrace SymTouch.

FAQs

Q: What is Zembrace SymTouch used for? A: Zembrace SymTouch is used for the treatment of acute migraine with or without aura in adults.

Q: Who acquired Zembrace SymTouch? A: Tonix Pharmaceuticals Holding Corp. acquired Zembrace SymTouch from Upsher-Smith Laboratories, LLC in July 2023.

Q: What is the patent status of Zembrace SymTouch? A: Zembrace SymTouch has patent protection until 2036.

Q: How much revenue did Zembrace SymTouch generate in the nine months ended September 30, 2024? A: Zembrace SymTouch generated $6.1 million in revenue for the nine months ended September 30, 2024.

Q: What are the operational challenges faced by Tonix Pharmaceuticals regarding Zembrace SymTouch? A: Tonix faces challenges such as declining revenues, delays in building out the sales team, and full impairment of developed technology intangible assets.

Cited Sources

1. Zacks Small-Cap Research: "Tonix Pharmaceuticals Holding Corp. Business Update" (July 6, 2023)
2. TradingView: "Tonix Pharmaceuticals Holding Corp. SEC 10-Q Report" (November 12, 2024)
3. DrugPatentWatch: "Generic SUMATRIPTAN INN equivalents, pharmaceutical patent"
4. Tonix Pharmaceuticals: "Tonix Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Highlights" (August 10, 2023)
5. BioSpace: "Tonix Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operational Highlights" (November 9, 2023)