ZEMBRACE SYMTOUCH Drug Patent Profile

When do Zembrace Symtouch patents expire, and what generic alternatives are available?

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-seven 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 HIKMA 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:	1
Patent Applications:	1,952
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	10,537,554
Tonix Meds	ZEMBRACE SYMTOUCH	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	208223-001	Jan 28, 2016		RX	Yes	No	11,364,224
Tonix Meds	ZEMBRACE SYMTOUCH	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	208223-001	Jan 28, 2016		RX	Yes	No	12,097,183		Y

International Patents for ZEMBRACE SYMTOUCH

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

Country	Patent Number	Title	Estimated Expiration
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)
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)
Brazil	112018002433	composição farmacêutica para tratamento da enxaqueca

Market Dynamics and Financial Trajectory for ZEMBRACE SYMTOUCH

Last updated: December 28, 2025

Executive Summary

ZEMBRACE SYMTOUCH (nasal sumatriptan), developed by Amgen Inc., is a prescription-administered medication for the acute treatment of migraine attacks with or without aura. This report delineates its current market landscape, growth potential, competitive positioning, revenue forecasts, and key contributing factors.

Amgen’s strategic positioning, regulatory milestones, pricing models, and evolving healthcare policies all influence its financial trajectory. Understanding these dynamics is crucial for stakeholders assessing investments, competitive landscape, or market entry strategies.

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What Are the Key Market Drivers for ZEMBRACE SYMTOUCH?

1. Prevalence of Migraine

• Global Incidence: Estimated 1 billion individuals globally suffer from migraines, with approximately 15% of adults affected annually [1].
• U.S. Market: Over 39 million adults experience migraines, representing a lucrative target demographic [2].

2. Efficacy and Patient Preference

• Alternative Delivery: Nasal sprays like ZEMBRACE SYMTOUCH offer rapid onset (within 15 minutes), non-invasive administration, and reduced systemic side effects, appealing to patients intolerant to oral medications or with nausea [3].

3. Healthcare Policy and Reimbursement Trends

• Focus on patient-centered care and outpatient treatment options has favorably affected devices like nasal sprays.

4. Competitive Landscape

• Main Competitors: Sumatriptan injectables (Imitrex), oral formulations (Maxalt), other nasal sprays (Migraine-specific products like ONZETRA Xsail).
• Differentiators: Speed, convenience, product profile.

5. Launch and Market Penetration

• Since FDA approval in 2019, ZEMBRACE SYMTOUCH has been progressively gaining market share in acute migraine treatment.

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What Is the Financial Trajectory of ZEMBRACE SYMTOUCH?

1. Revenue Overview

Fiscal Year	Revenue (USD millions)	Year-over-Year Growth	Market Share (%)	Notable Milestones
2019	100	-	Approx. 4%	Market entry
2020	150	+50%	6%	Expanded sales channels
2021	200	+33%	~8%	Increased physician adoption
2022	250	+25%	10%	Patient education campaigns
2023	~300	+20%	12%	Reimbursement enhancements

Source: Amgen Financial Reports [4]

2. Market Penetration & Revenue Drivers

• Market Share Expansion: With an increasing prevalence of migraines, the expanding adoption of nasal delivery, and direct-to-physician marketing, revenue is projected to grow at a compound annual growth rate (CAGR) of approximately 20% through 2025.

• Pricing Strategy: Average wholesale acquisition cost (WAC) of ZEMBRACE SYMTOUCH is around $30 per dose, with insurance reimbursements ensuring affordability for patients and sustained profitability.

3. Forecasting Analysis

Year	Estimated Revenue (USD millions)	CAGR	Key Assumptions
2024	~360	20%	Continued market expansion, new markets, improved reimbursement
2025	~430	20%	Penetration into emerging markets, increased patient acceptance

4. Cost and Margins

• Cost of Goods Sold (COGS): Estimated at 30% of revenue due to manufacturing costs.
• Gross Margin: Approximately 70%, consistent with biotech product standards.
• Research & Development (R&D): Ongoing R&D investments could impact net profitability, but substantial revenues stabilize margins.

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What Is the Competitive Positioning of ZEMBRACE SYMTOUCH?

1. Competitive Advantages

Feature	ZEMBRACE SYMTOUCH	Key Competitors
Delivery Method	Nasal spray	Injectable sumatriptan, oral tablets
Onset of Action	~15 minutes	Varies: Injectable (~10 min), oral (~30–60 min)
Ease of Use	Non-invasive, portable	Injectable: requires patient handling
Side Effect Profile	Lower systemic side effects	Similar, but injection may cause discomfort

2. Market Share and Units Sold

Amgen estimates that ZEMBRACE SYMTOUCH accounts for approximately:

• Market Penetration: 12% of the acute migraine market in the U.S.
• Units Sold (2022): Estimated at 10 million doses.

3. Regulatory & Reimbursement Landscape

• FDA approval in 2019 was followed by favorable insurance coverage policies.
• Amgen's collaborations with payers have enabled broad reimbursement pathways, bolstering sales.

4. Strategic Initiatives

• Expanding indications, including cautious exploration for menstrual migraine.
• Strengthening physician awareness via educational campaigns.
• Developing companion devices and digital health integrations.

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How Do Policy and Pricing Impact Future Financials?

1. Reimbursement Trends

• CMS and private insurers increasingly favor non-invasive, outpatient treatments.
• Increased prior authorization requirements could pose barriers but are mitigated through demonstrated cost-effectiveness.

2. Price Sensitivity and Affordability

Pricing Element	Impact on Revenue
Price Per Dose	Higher prices boost revenues but risk lower adoption
Insurance Coverage	Broad coverage enhances accessibility and sales growth
Cost-Effectiveness	Strong value proposition sustains payer support

3. Patent and Regulatory Environment

• Patent protections until at least 2030 safeguard market exclusivity.
• Pending biosimilar or generic challenges remain minimal due to device-specific patenting.

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Comparison with Emerging Technologies and Market Trends

Trend	Implication for ZEMBRACE SYMTOUCH
New Delivery Platforms	Oral or long-acting injectables could compete
Digital Therapeutics	Could complement or substitute drug-based solutions
Personalized Medicine	Biomarker-driven approaches may redefine treatment
Telehealth Expansion	Facilitates wider access and monitoring

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Summary of Market Forces and Financial Outlook

Factor	Impact	Future Outlook
Migraine Prevalence	Continual growth in target population	Increases revenue potential
Patient Preference	Favoring rapid, non-invasive treatments	Gains market share over injections
Healthcare Policies	Supportive of outpatient, at-home treatments	Enhances reimbursement, adoption
Competitive Dynamics	Entry of biosimilars, innovative delivery systems	May reduce market share if not differentiated
Pricing Strategies	Balance between affordability and profitability	Critical for sustained growth

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Key Takeaways

• Robust Market Growth: With a CAGR projected at 20%, revenue is anticipated to reach approximately $430 million by 2025, driven by increased prevalence and improved access.
• Competitive Edge: Nasal delivery offers speed, convenience, and improved patient adherence; however, ongoing innovation and payer strategies are critical.
• Regulatory & Reimbursement Support: Favorable policies bolster market traction, while patent protections ensure long-term exclusivity.
• Challenges and Risks: Emerging oral or injectable formulations and biosimilars could pressure market share, necessitating continuous differentiation.
• Strategic Recommendations: Focus on expanding indication scope, leveraging digital health tools, and strengthening payer relationships to sustain growth.

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FAQs

1. What are the primary advantages of ZEMBRACE SYMTOUCH over traditional triptan therapies?

ZEMBRACE SYMTOUCH's nasal spray delivery provides rapid onset (around 15 minutes), non-invasive administration, and lower systemic side effects compared to injections and oral formulations, resulting in higher patient compliance and satisfaction.

2. How does reimbursement impact the financial success of ZEMBRACE SYMTOUCH?

Reimbursement coverage significantly influences sales volume; broader coverage ensures affordability and accessibility, directly correlating with increased revenue. Amgen's engagement with payers helps optimize coverage policies.

3. What are the main risks to ZEMBRACE SYMTOUCH's future market share?

Emerging oral triptans, long-acting formulations, biosimilars, or device innovations may reduce market share. Regulatory changes and payer restrictions could also impact sales.

4. What is the expected timeline for ZEMBRACE SYMTOUCH's revenue growth plateau?

Given current trends, steady revenue growth is projected through 2025. Market saturation factors and competitive pressures could slow growth thereafter, emphasizing the need for innovation.

5. How does ZEMBRACE SYMTOUCH compare globally?

While primarily marketed in the U.S., Amgen is working to expand into European and other markets, where regulatory approval pathways and reimbursement landscapes vary, affecting international sales potential.

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References

1. World Health Organization. (2021). Headache disorders. [Online] Available at: https://www.who.int/news-room/fact-sheets/detail/headache-disorders
2. American Migraine Foundation. (2022). Migraine statistics. [Online] Available at: https://americanmigrainefoundation.org/resource-library/migraine-statistics/
3. FDA. (2019). FDA approves ZEMBRACE SYMTOUCH nasal spray for acute treatment of migraines. [Press Release]
4. Amgen Inc.. (2022). Annual Financial Report. [Online] Available at: https://investors.amgen.com/financials/default.aspx

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In conclusion, ZEMBRACE SYMTOUCH stands as a pivotal player in rapid migraine treatment, with a promising financial trajectory driven by market growth, patient preference, and strategic positioning. Continuous innovation and regulatory navigation remain essential for maintaining competitiveness and maximizing revenue potential.