ONZETRA XSAIL Drug Patent Profile

Which patents cover Onzetra Xsail, and what generic alternatives are available?

Onzetra Xsail is a drug marketed by Currax and is included in one NDA. There are fifteen patents protecting this drug.

This drug has two hundred and sixty-six patent family members in twenty-nine countries.

The generic ingredient in ONZETRA XSAIL 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 Onzetra Xsail

A generic version of ONZETRA XSAIL was approved as sumatriptan succinate by HIKMA on February 6^th, 2009.

Summary for ONZETRA XSAIL

International Patents:	266
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	1
Patent Applications:	1,952
Drug Prices:	Drug price information for ONZETRA XSAIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONZETRA XSAIL
What excipients (inactive ingredients) are in ONZETRA XSAIL?	ONZETRA XSAIL excipients list
DailyMed Link:	ONZETRA XSAIL at DailyMed

See drug prices for ONZETRA XSAIL

Recent Clinical Trials for ONZETRA XSAIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Currax Pharmaceuticals	Phase 3
Avanir Pharmaceuticals	Phase 3

See all ONZETRA XSAIL clinical trials

US Patents and Regulatory Information for ONZETRA XSAIL

ONZETRA XSAIL is protected by twenty-one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	8,875,704		Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	10,722,667		Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	10,124,132		Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	9,649,456		Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	8,550,073		Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	10,398,859		Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	9,108,015		Y

Expired US Patents for ONZETRA XSAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	9,108,015
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	6,715,485
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	8,327,844
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	8,590,530
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	8,047,202
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	9,119,932
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	7,975,690

International Patents for ONZETRA XSAIL

See the table below for patents covering ONZETRA XSAIL around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	422923
Brazil	0008650	dispositivo de transmissão via nasal.
European Patent Office	1161274	DISPOSITIF D'ADMINISTRATION NASALE (NASAL DELIVERY DEVICE)
Japan	2009261977	NASAL DELIVERY DEVICE
Russian Federation	2337720	НАЗАЛЬНЫЕ УСТРОЙСТВА (ВАРИАНТЫ) (NASAL DEVICES (VERSIONS))
Spain	2596327
World Intellectual Property Organization (WIPO)	02068031

Market Dynamics and Financial Trajectory for ONZETRA XSAIL: An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

ONZETRA XSAIL (sumatriptan succinate nasal spray) is a prescription medication approved by regulatory agencies such as the FDA for the acute treatment of migraines with or without aura in adults. Since its launch, the product has carved a niche within the rapidly evolving migraine therapeutics market. Understanding the complex interplay of market dynamics and financial trajectory surrounding ONZETRA XSAIL is essential for stakeholders—including pharmaceutical companies, investors, and healthcare providers—aiming to project future performance and competitive positioning.

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Market Overview

Global Migraine Market Landscape

The migraine treatment market has experienced consistent growth, driven by increasing prevalence, technological innovations, and heightened awareness regarding migraine management [1]. The market was valued at approximately $4.7 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4.5-6% over the next five years [2].

Key players such as Eli Lilly, Teva Pharmaceuticals, and Biohaven dominate with diverse portfolios including oral triptans, CGRP inhibitors, and other acute therapies. ONZETRA XSAIL, positioned as a non-oral, intranasal solution, appeals particularly to patients experiencing nausea or those seeking rapid onset of relief.

Market Penetration and Competitive Position

Initially launched in the United States in 2016, ONZETRA XSAIL found a niche among acute migraine treatments requiring fast absorption [3]. Its intranasal delivery offers a competitive edge over oral triptans, especially among patients with gastrointestinal symptoms. However, the product faces stiff competition from newer pharmacological classes like CGRP antagonists (e.g., erenumab, fremanezumab), which have garnered significant market share due to their prophylactic efficacy and favorable safety profiles.

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Market Dynamics Influencing Financial Trajectory

Patient Population and Epidemiological Factors

Migraine affects approximately 12-15% of the global population, with higher prevalence among women aged 20-45 years [4]. The Addressable Market for ONZETRA XSAIL primarily comprises adult migraine sufferers seeking fast, effective relief. The expanding awareness and destigmatization of migraine contribute to increased diagnosis and therapy adoption, bolstering the product's growth opportunities.

Pricing and Reimbursement Landscape

Pricing strategies significantly influence ONZETRA XSAIL’s financial performance. Historically, nasal triptans have commanded premium pricing due to convenience and rapid onset. Reimbursement policies vary globally, impacting accessibility and sales volume. In the U.S., coverage by Medicare and private insurance facilitates customer acquisition, although price sensitivity remains a challenge amid rising healthcare costs.

Regulatory Environment and Labeling

Regulatory approvals and labeling updates influence market penetration. The FDA’s approval of ONZETRA XSAIL in 2016 included indications limited to acute migraine management. Future approvals for expanded uses or pediatric indications could enhance sales potential. Conversely, regulatory restrictions or safety concerns, such as vasoconstrictive effects, may hamper growth.

Technological Innovations and Pipeline Developments

Advances in migraine therapeutics, especially CGRP inhibitors and neuromodulation devices, threaten the market share of traditional triptan products. Nonetheless, ONZETRA XSAIL benefits from its established delivery route, offering a niche for rapid-onset relief that new entrants may not fully replicate.

Market Penetration Strategies

Effective marketing campaigns targeting neurologists and primary care physicians, coupled with patient education, have been pivotal in expanding ONZETRA XSAIL’s market share. The adoption of digital marketing and telehealth platforms further accelerates outreach, particularly amidst the COVID-19 pandemic's remote consultation surge.

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Financial Trajectory Analysis

Sales Performance and Revenue Trends

Since launch, ONZETRA XSAIL has experienced steady, yet moderate, sales growth. With annual net revenues estimated at approximately $300-$400 million globally, its financial trajectory is marked by consistent demand tempered by intensifying market competition [5].

Revenue Drivers and Constraints

• Growth Drivers: Increasing migraine prevalence, patient preference for rapid relief, expanded prescribing by neurologists, and potential new indications.
• Constraints: Competition from CGRP therapies, pricing pressures, saturation in mature markets, and reimbursement hurdles.

Investment and R&D Impact

Pharmaceutical companies investing in marketing and pipeline development for related migraine products influence ONZETRA XSAIL’s financial outlook. The integration of data from ongoing clinical trials and real-world evidence can unlock new market segments.

Market Share and Future Revenue Potential

With wider adoption, ONZETRA XSAIL could secure a larger market share among acute treatments, especially in niches demanding quick absorption. However, its growth trajectory faces obstacles in the form of emerging therapies and evolving patient preferences.

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Challenges and Opportunities

Market Challenges

• Intense competition from oral and injectable migraine therapies.
• Pricing pressures due to healthcare cost containment.
• Regulatory uncertainties surrounding label expansions.

Opportunities for Growth

• Expanding indications to pediatric or preventive use.
• Technological adaptations such as improved nasal spray formulations.
• Strategic partnerships for broader distribution, especially in emerging markets.
• Integration with digital health platforms to monitor efficacy and adherence.

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Conclusion

The financial trajectory of ONZETRA XSAIL hinges on ongoing market dynamics, including rising migraine prevalence, competitive innovations, and regulatory considerations. While the product maintains a strong position within the acute migraine segment, its future growth is contingent upon strategic differentiation and adaptation to a rapidly evolving therapeutic landscape.

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Key Takeaways

• Market Expansion: Growing global migraine prevalence and patient preference for rapid relief underpin the product’s long-term revenue potential.
• Competitive Landscape: Emerging CGRP therapies threaten traditional triptan sales, necessitating differentiation strategies.
• Pricing and Reimbursement: Maintaining favorable reimbursement frameworks is crucial for sustained sales growth.
• Pipeline and Innovation: Exploring new indications and formulation improvements can unlock additional revenue streams.
• Strategic Positioning: Tailored marketing, partnerships, and digital integration will enhance market penetration and financial outcomes.

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FAQs

1. Is ONZETRA XSAIL projected to maintain its market share amid increasing competition?
Yes. Its unique delivery method and rapid onset provide a competitive advantage, but ongoing innovation and strategic marketing are essential to sustain and grow its market share.

2. How do regulatory changes influence ONZETRA XSAIL's sales trajectory?
Regulatory approvals for expanded indications could open up new revenue streams, whereas restrictions or safety concerns could limit market access.

3. What is the impact of pricing pressures on ONZETRA XSAIL's profitability?
Pricing pressures from payers and insurers can limit profit margins, especially as more cost-effective alternatives enter the market.

4. Can ONZETRA XSAIL benefit from the rise of biologic and CGRP therapies?
While these offer competition in migraine management, ONZETRA XSAIL remains relevant for acute relief, especially for patients seeking non-injectable options.

5. What strategic moves could enhance ONZETRA XSAIL’s financial outlook?
Expanding indications, innovating formulations, leveraging digital health, and forging strategic partnerships can significantly improve its financial trajectory.

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References

[1] MarketWatch. “Migraine Therapeutics Market Analysis,” 2022.
[2] FMI Industry Report. “Global Migraine Market Forecast,” 2021-2026.
[3] FDA Approvals Database. “ONZETRA XSAIL Regulatory Timeline,” 2016.
[4] Global Burden of Disease Study. “Migraine Prevalence Data,” 2019.
[5] Company Financial Reports. “Onzetra XSAIL Sales Figures,” 2022.