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 sixteen 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-five 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 WEST-WARD PHARMS INT on February 6^th, 2009.

Summary for ONZETRA XSAIL

International Patents:	266
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	1
Patent Applications:	2,223
Drug Prices:	Drug price information 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
Avanir Pharmaceuticals	Phase 3
Currax Pharmaceuticals	Phase 3

See all ONZETRA XSAIL clinical trials

Pharmacology for ONZETRA XSAIL

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 ONZETRA XSAIL

ONZETRA XSAIL is protected by twenty-two 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

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	9,119,932
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	8,555,877

International Patents for ONZETRA XSAIL

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2004100276
European Patent Office	1365827	Dispositifs de distribution pour le nez (Nasal delivery devices)
Canada	2918226	DISPOSITIF D'ADMINISTRATION NASALE SERVANT A ADMINISTRER UNE SUBSTANCE DANS UNE CAVITE NASALE D'UN SUJET (NASAL DELIVERY DEVICE FOR DELIVERING SUBSTANCE TO A NASAL CAVITY OF A SUBJECT)

ONZETRA XSAIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ONZETRA® Xsail®

Introduction to ONZETRA® Xsail®

ONZETRA® Xsail®, a sumatriptan nasal powder, is a medication approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine pain in adults, with or without aura. This innovative drug is administered via a breath-powered exhalation delivery system, providing targeted and efficient delivery of sumatriptan deep into the nasal cavity, an area rich with blood vessels[4].

Market Need and Patient Satisfaction

Despite advances in migraine therapy, many patients continue to suffer from debilitating migraine pain and are often dissatisfied with their current treatments. ONZETRA® Xsail® addresses this unmet need by offering a unique delivery mechanism that can provide fast relief.

"Despite the recent advances in migraine therapy, many patients still suffer debilitating migraine pain and are dissatisfied with their current treatments," said Stewart Tepper, MD, professor of Neurology, Geisel School of Medicine at Dartmouth[4].

Acquisition and Ownership

ONZETRA® Xsail® was initially developed by OptiNose AS, a subsidiary of OptiNose, Inc. (Nasdaq: OPTN). In September 2019, Currax Pharmaceuticals LLC acquired the North American patent rights to ONZETRA® Xsail® from OptiNose AS. This acquisition marked Currax’s first major move in expanding its branded product portfolio[4].

Financial Performance Pre-Acquisition

Before the acquisition by Currax, ONZETRA® Xsail® was part of OptiNose’s product portfolio. While specific financial details for ONZETRA® Xsail® alone are not readily available, OptiNose's overall financial performance can provide some context. OptiNose has reported revenues from its other products, such as XHANCE, but the financial impact of ONZETRA® Xsail® on OptiNose's balance sheet is not explicitly stated in the available sources.

Post-Acquisition Financial Trajectory

Following the acquisition by Currax Pharmaceuticals, ONZETRA® Xsail® became a key component of Currax’s branded portfolio. Here are some key financial and operational highlights:

Revenue Growth

• Currax exceeded its 2019 growth expectations, generating over $70 million in revenue in just eight months of operations. This strong performance was partly driven by the addition of ONZETRA® Xsail® to its portfolio[5].

Debt Reduction and Cash Flow

• The substantial cash flow generated by Currax enabled a 30% reduction in debt, indicating a robust financial position that could support further investments in the branded portfolio, including ONZETRA® Xsail®[5].

Strategic Focus

• Currax’s strategy is focused on driving profitable growth for ONZETRA® Xsail®, along with other recently acquired products like CONTRAVE®. The company is also actively evaluating strategic acquisition opportunities to further enhance its portfolio[5].

Sales and Operational Efficiencies

• Currax introduced a new enterprise resource planning (ERP) platform and a customer relationship management (CRM) system, as well as created an in-house sales force. These initiatives are aimed at driving operational efficiencies and scaling the business, which includes the sales and marketing efforts for ONZETRA® Xsail®[5].

Market Dynamics

Competitive Landscape

The migraine treatment market is competitive, with various oral, injectable, and nasal formulations available. However, ONZETRA® Xsail® stands out due to its unique breath-powered delivery system, which offers targeted and efficient delivery of sumatriptan.

Patient Access and Satisfaction

Currax’s acquisition of ONZETRA® Xsail® aligns with its mission to create greater patient access to life-changing medicines. The drug’s innovative delivery mechanism and potential for fast relief are significant factors in patient satisfaction and adherence.

Regulatory Environment

ONZETRA® Xsail® was approved by the FDA on January 28, 2016, for the acute treatment of migraine pain in adults. This regulatory approval is crucial for its market presence and acceptance by healthcare providers and patients[4].

Future Outlook

Growth Projections

Currax anticipates annual revenues in excess of $100 million, driven by the growth in its branded portfolio, which includes ONZETRA® Xsail®. This projection indicates a positive outlook for the drug’s financial trajectory[5].

Strategic Acquisitions

Currax is actively evaluating strategic acquisition opportunities to advance its mission and expand its portfolio. This strategy could further enhance the market position and financial performance of ONZETRA® Xsail®[5].

Key Takeaways

• Innovative Delivery Mechanism: ONZETRA® Xsail® offers a unique breath-powered exhalation delivery system, providing targeted and efficient delivery of sumatriptan.
• Strong Financial Performance: The acquisition by Currax has contributed to the company's strong revenue growth and cash flow, enabling debt reduction and strategic investments.
• Market Need: The drug addresses an unmet need in migraine therapy, offering potential for fast relief and higher patient satisfaction.
• Regulatory Approval: FDA approval in 2016 has been a critical factor in the drug’s market presence.
• Future Growth: Currax’s strategy and financial projections indicate a positive outlook for the drug’s continued growth and market dominance.

FAQs

1. What is ONZETRA® Xsail® used for?

   • ONZETRA® Xsail® is used for the acute treatment of migraine pain in adults, with or without aura.

2. How is ONZETRA® Xsail® administered?

   • It is administered via a breath-powered exhalation delivery system, delivering sumatriptan deep into the nasal cavity.

3. Who acquired the rights to ONZETRA® Xsail® in North America?

   • Currax Pharmaceuticals LLC acquired the North American patent rights to ONZETRA® Xsail® from OptiNose AS in September 2019.

4. What were the financial highlights for Currax after acquiring ONZETRA® Xsail®?

   • Currax exceeded its 2019 growth expectations, generating over $70 million in revenue in eight months, and reduced its debt by 30%.

5. What is Currax’s strategy for ONZETRA® Xsail® and other branded products?

   • Currax is focused on driving profitable growth for ONZETRA® Xsail® and other branded products, while evaluating strategic acquisition opportunities to enhance its portfolio.

Sources

1. Currax Pharmaceuticals Delivers Strong Operational and Financial Performance Eight Months into Operations - Currax Pharmaceuticals Press Release, February 27, 2020.
2. Optinose Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights - Optinose IR News Release.
3. Annual Report 2016 - Otsuka Pharmaceutical.
4. Currax™ Pharmaceuticals LLC Announces First Acquisition: Acquires North American Rights to ONZETRA® Xsail® - Currax Pharmaceuticals Press Release, September 25, 2019.
5. Currax Pharmaceuticals Delivers Strong Operational and Financial Performance Eight Months into Operations - PR Newswire, February 27, 2020.