ZECUITY Drug Patent Profile

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

Zecuity is a drug marketed by Teva Branded Pharm and is included in one NDA. There are nine patents protecting this drug.

This drug has ninety-two patent family members in fourteen countries.

The generic ingredient in ZECUITY 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 Zecuity

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

Summary for ZECUITY

International Patents:	92
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	1
Patent Applications:	5,542
DailyMed Link:	ZECUITY at DailyMed

Recent Clinical Trials for ZECUITY

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

Sponsor	Phase
NuPathe Inc.	Phase 1

See all ZECUITY clinical trials

US Patents and Regulatory Information for ZECUITY

ZECUITY 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
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No	7,973,058
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No	9,327,114		Y
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No	8,470,853
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No	8,597,272		Y

Expired US Patents for ZECUITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013	6,745,071

International Patents for ZECUITY

See the table below for patents covering ZECUITY around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004075980
Canada	2944660	REGULATION ELECTRONIQUE D'UN SYSTEME DE DISTRIBUTION DE MEDICAMENT (ELECTRONIC CONTROL OF DRUG DELIVERY SYSTEM)
Eurasian Patent Organization	023339	УСИЛЕННЫЕ ПОЛИАМИНОМ СОСТАВЫ ДЛЯ ИОНТОФОРЕЗА СОЕДИНЕНИЯ ТРИПТАНА (POLYAMINE ENHANCED FORMULATIONS FOR TRIPTAN COMPOUND IONTOPHORESIS)
Australia	2015224400	Polyamine enhanced formulations for triptan compound iontophoresis

ZECUITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZECUITY

Introduction to ZECUITY

ZECUITY, developed by NuPathe Inc., is a groundbreaking drug/device combination product designed to treat migraines. It is the first and only FDA-approved prescription migraine patch, delivering sumatriptan, the most widely prescribed migraine medication, through the skin using an iontophoretic transdermal system[1][4][5].

FDA Approval and Clinical Trials

ZECUITY was approved by the U.S. Food and Drug Administration (FDA) in January 2013 for the acute treatment of migraine with or without aura in adults. The approval was based on an extensive development program that included phase 3 trials involving 793 patients and nearly 10,000 ZECUITY patches. These trials demonstrated a favorable safety profile and effectiveness in relieving migraine headache pain and migraine-related nausea two hours after patch activation[1][2][5].

Acquisition by Endo Health Solutions

In December 2013, Endo Health Solutions announced its acquisition of NuPathe Inc. for $2.85 per share in cash, or approximately $105 million. This transaction also included contingent cash consideration payments of up to $3.15 per share if specified net sales milestones for ZECUITY were achieved. The acquisition was seen as a strategic move to enhance Endo's branded pharmaceutical portfolio and leverage its commercial expertise in pain and migraine management[1].

Market Launch and Commercialization

Following the acquisition, Endo planned to launch ZECUITY in the first half of 2014, utilizing its existing commercial infrastructure. The launch was expected to capitalize on Endo's leadership in pain management and the significant market potential for a novel migraine treatment. ZECUITY was eventually made available by prescription through specialty pharmacies, targeting the approximately 36 million people in the United States who suffer from migraines[1][4].

Financial Projections and Milestones

The acquisition and subsequent launch of ZECUITY were expected to be accretive to Endo's adjusted diluted earnings per share within the first 12 months. The contingent cash consideration payments were tied to specific net sales milestones:

• $2.15 per share if net sales of ZECUITY exceeded $100 million during any four-quarter period prior to the ninth anniversary of the first commercial sale.
• An additional $1.00 per share if net sales exceeded $300 million during any four-quarter period prior to the ninth anniversary of the first commercial sale[1].

Market Reception and Patient Needs

ZECUITY addressed a significant unmet need in the migraine treatment market, particularly for patients experiencing migraine-related nausea. According to the American Migraine Study II, many migraine sufferers experience nausea, which can lead to delayed or avoided treatment. ZECUITY's non-oral delivery mechanism provided a valuable alternative for these patients[4].

Competitive Landscape and Market Dynamics

The biopharma sector, including the migraine treatment market, has seen significant activity in recent years. The market rally in 2023 and the beginning of 2024 has been driven by a rebound in M&A deals and continued enthusiasm around innovative drug classes. However, the sector also faces challenges such as health care cost containment and regulatory approvals[3].

Distribution and Availability

After its launch, ZECUITY was made available through specialty pharmacies, ensuring targeted distribution to patients who could benefit most from this novel treatment. This strategic distribution helped in reaching the intended patient population effectively[4].

Risks and Uncertainties

The success of ZECUITY was not without risks. Factors such as the degree to which the transaction would be accretive to Endo, the ability to launch ZECUITY on schedule, and the achievement of net sales milestones were critical. Additionally, general industry conditions, economic factors, and regulatory approvals posed potential challenges[1].

Expert Insights

Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva, highlighted the importance of ZECUITY for migraine sufferers, especially those experiencing nausea. He noted that such patients often seek non-oral treatment options, making ZECUITY a valuable addition to the treatment landscape[4].

Financial Performance and Impact

While specific financial performance data for ZECUITY post-launch is not detailed in the sources, the acquisition and launch were expected to contribute positively to Endo's financials. The contingent cash payments tied to sales milestones indicated a strong potential for revenue growth if the product met its market expectations[1].

Conclusion

ZECUITY represents a significant innovation in migraine treatment, offering a unique delivery mechanism that addresses the needs of patients experiencing migraine-related nausea. The acquisition by Endo Health Solutions and subsequent launch were strategic moves aimed at leveraging market potential and enhancing Endo's portfolio. Despite the risks and uncertainties, ZECUITY's approval and market reception underscore its importance in the biopharma sector.

Key Takeaways

• Innovative Treatment: ZECUITY is the first and only FDA-approved prescription migraine patch.
• Acquisition and Launch: Acquired by Endo Health Solutions in 2013, with a planned launch in the first half of 2014.
• Market Potential: Targets approximately 36 million migraine sufferers in the U.S., particularly those with migraine-related nausea.
• Financial Projections: Expected to be accretive to Endo's earnings, with contingent cash payments tied to sales milestones.
• Distribution: Available through specialty pharmacies to ensure targeted distribution.
• Risks and Uncertainties: Includes factors such as regulatory approvals, industry conditions, and economic factors.

FAQs

What is ZECUITY and how does it work?

ZECUITY is a single-use, battery-powered patch that delivers sumatriptan, the most widely prescribed migraine medication, through the skin using an iontophoretic transdermal system.

Who developed and approved ZECUITY?

ZECUITY was developed by NuPathe Inc. and approved by the U.S. Food and Drug Administration (FDA) in January 2013.

What was the significance of the acquisition by Endo Health Solutions?

The acquisition by Endo Health Solutions was a strategic move to enhance its branded pharmaceutical portfolio and leverage its commercial expertise in pain and migraine management.

How is ZECUITY distributed?

ZECUITY is available by prescription through specialty pharmacies.

What are the potential financial benefits of ZECUITY for Endo Health Solutions?

The acquisition and launch of ZECUITY were expected to be accretive to Endo's adjusted diluted earnings per share, with additional contingent cash payments tied to specific net sales milestones.

Sources

1. Endo to Acquire Specialty Pharmaceutical Company NuPathe - PR Newswire
2. Zecuity (sumatriptan iontophoretic transdermal system) - FDA
3. The Quarterly Rx: Q1 2024 US Biopharma Recap - William Blair
4. Teva Announces U.S. Availability of ZECUITY - Teva Pharmaceutical Industries Ltd.
5. NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine - FierceBiotech