SUMAVEL DOSEPRO Drug Patent Profile

Which patents cover Sumavel Dosepro, and when can generic versions of Sumavel Dosepro launch?

Sumavel Dosepro is a drug marketed by Endo Operations and is included in one NDA. There are two patents protecting this drug.

This drug has fourteen patent family members in eight countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sumavel Dosepro

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

Summary for SUMAVEL DOSEPRO

International Patents:	14
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	1
Patent Applications:	1,952
Drug Prices:	Drug price information for SUMAVEL DOSEPRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUMAVEL DOSEPRO
What excipients (inactive ingredients) are in SUMAVEL DOSEPRO?	SUMAVEL DOSEPRO excipients list
DailyMed Link:	SUMAVEL DOSEPRO at DailyMed

See drug prices for SUMAVEL DOSEPRO

Recent Clinical Trials for SUMAVEL DOSEPRO

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

Sponsor	Phase
Synteract, Inc.	Phase 4
Zogenix, Inc.	Phase 4

See all SUMAVEL DOSEPRO clinical trials

US Patents and Regulatory Information for SUMAVEL DOSEPRO

SUMAVEL DOSEPRO is protected by 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
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-002	Nov 26, 2013		DISCN	Yes	No
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y

Expired US Patents for SUMAVEL DOSEPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009

International Patents for SUMAVEL DOSEPRO

See the table below for patents covering SUMAVEL DOSEPRO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2010046509	NEEDLELESS INJECTOR WITH SHOCK ABSORBING MEANS BETWEEN RAM AND PISTON
World Intellectual Property Organization (WIPO)	9628202
Norway	974164
United Kingdom	9606904

Market Dynamics and Financial Trajectory for SUMAVEL DOSEPRO

Last updated: July 30, 2025

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Introduction

SUMAVEL DOSEPRO, marketed primarily by ZOSRAY LLC (formerly via ZOSRAY LLC's predecessor companies), is an autoinjector device delivering sumatriptan for acute migraine treatment. Its unique mechanism of administration positioned it as an alternative to traditional oral tablets and injectable forms. Understanding the market dynamics and financial trajectory of SUMAVEL DOSEPRO involves examining its therapeutic niche, competitive landscape, regulatory environment, and commercial performance since its introduction.

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Product Overview and Market Position

SUMAVEL DOSEPRO, approved by the FDA in 2009, utilizes a discreet, needle-free autoinjector technology for rapid migraine relief. Its primary differentiator has been its needle-free design, appealing to patients with needle phobia or those seeking convenient, rapid administration. Its formulation of sumatriptan, a well-established triptan, ensures familiarity within the migraine therapeutic space.

The product positioned itself in the acute migraine treatment market, competing with oral triptans, nasal sprays, and other injectable formulations like Imitrex STATdose. According to IQVIA and industry reports, the global migraine market was valued at over $4 billion in recent years, with a steady compound annual growth rate (CAGR) of approximately 4-5%.

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Market Dynamics

Demand Factors

• Patient Acceptance & Preference: The needle-free autoinjector appeals broadly to patients with needle anxiety, fostering increased adherence and satisfaction. This preference shift enhances demand.

• Migraine Prevalence: Migraines afflict over 1 billion globally, with a substantial percentage prescribed acute treatments like SUMAVEL DOSEPRO. The increasing awareness and diagnosis rates directly influence product demand.

• Physician Familiarity: As sumatriptan has historically been a first-line migraine agent, physician familiarity supports prescription continuity. However, prescriber preferences are increasingly moving toward novel therapies like CGRP antagonists, which may impact long-term demand.

Market Competition

• Older Formulations: Traditional oral triptans remain cost-effective and widely prescribed. SUMAVEL DOSEPRO's niche caters to specific patient subsets, limiting mass-market penetration.

• Newer Therapies: The advent of CGRP monoclonal antibodies and gepants has introduced alternatives, often preferred for their safety profiles and efficacy in refractory cases. This emerging competition could limit growth prospects for SUMAVEL DOSEPRO.

• Device Market: Between traditional injections and nasal sprays, the device's convenience and needle-free design bolster its market appeal, yet innovations from competitors diminish its exclusivity.

Regulatory and Reimbursement Landscape

• FDA Approvals: The initial 2009 approval established a clear regulatory pathway, subsequently expanded to include updates and additional indications; however, newer competitors benefited from accelerated approvals via breakthrough designation.

• Reimbursement: Insurance coverage and reimbursement policies significantly influence prescription patterns. Historically, autoinjector devices often face reimbursement challenges due to device costs compared to oral formulations.

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Financial Trajectory

Sales Performance

• Initial Launch: Post-approval, SUMAVEL DOSEPRO demonstrated promising sales, driven by its novel delivery system. Industry sources suggest annual sales in the low hundreds of millions USD, though exact figures are proprietary.

• Market Saturation and Decline: Over the past decade, sales plateaued and declined, primarily attributed to:

  • The increasing presence of alternative delivery devices (e.g., nasal sprays, self-injection pens).
  • Emergence of newer, more efficacious, or better-tolerated therapies.
  • Cost pressures and insurance reimbursement hurdles.

Strategic Challenges

• Patent and Exclusivity: Considering its age, SUMAVEL DOSEPRO's patent exclusivity has likely expired or is nearing expiration, heightening generic competition risks, although device-specific patents may potentially extend protection.

• Product Lifecycle: The product appears to be in the maturity or decline phase within its lifecycle, pressured by innovation and shifting physician/patient preferences.

Financial Outlook

• Current Valuation: Precise financial data remains proprietary. An analysis indicates potential revenue decline, with the product's contribution to parent companies' portfolios diminishing. Industry analyses suggest modest, if any, growth prospects absent new formulations or indications.

• Future Prospects: Accelerating adoption of alternative therapies and technological innovations pose significant headwinds. Unless reinvested with new device versions or administered in combination therapies, SUMAVEL DOSEPRO could see further erosion in market share.

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Market Trends and Future Outlook

1. Shift Toward Novel Therapies: The trend is moving toward oral gepants and monoclonal CGRP antagonists (e.g., erenumab, fremanezumab), which offer improved safety and convenience profiles. These drugs are likely to supplant older injectable devices over time.

2. Device Innovation and Differentiation: The success of device-specific modifications, such as smaller, more portable autoinjectors or combined delivery systems, could offer revitalization opportunities.

3. Regulatory and Market Expansion: Broadening indications, exploring prophylactic use, or including special populations like pediatric patients could provide incremental growth avenues.

4. Market Penetration Challenges: Pricing pressures, insurance reimbursement policies, and changing clinician prescribing behaviors are anticipated to constrain revenue growth.

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Regulatory Developments and Impact

Recent regulatory trends favor the development of specialized delivery devices. While SUMAVEL DOSEPRO maintains FDA approval status, the lack of recent updates or indications limits growth potential unless linked with new formulations or uses. Export markets remain relatively underdeveloped, providing limited expansion opportunities outside North America.

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Key Takeaways

• Niche Positioning: SUMAVEL DOSEPRO carved a distinct segment with its needle-free injection technology, but this niche faces erosion due to emerging therapies.

• Market Challenges: Competition from oral and nasal formulations, coupled with newer injectable devices, constrains revenue growth and may lead to product obsolescence.

• Financial Outlook: The product's sales trajectory indicates a plateau or decline, with limited prospects unless revitalized through innovation or new indications.

• Strategic Imperatives: Companies must explore device enhancements, broader indications, or combination therapies to prolong the product’s lifecycle and mitigate competitive threats.

• Industry Lessons: The case emphasizes the importance of continuous innovation in drug delivery systems to sustain market relevance amid rapid advancements in pharmacotherapy.

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FAQs

Q1: How does SUMAVEL DOSEPRO differentiate itself from other migraine treatments?
A1: Its needle-free autoinjector technology provides rapid, convenient administration, appealing particularly to needle-averse patients or those seeking quick relief without the discomfort associated with traditional injections.

Q2: What factors threaten the future viability of SUMAVEL DOSEPRO?
A2: Increasing competition from oral trigans, nasal spray formulations, and emerging CGRP therapies, along with patent expirations and reimbursement challenges, threaten its market position.

Q3: Are there ongoing efforts to reinvigorate SUMAVEL DOSEPRO?
A3: Currently, there are limited publicly available initiatives. Future growth may depend on device upgrades, new indications, or combination strategies, but specific plans remain unconfirmed.

Q4: How significant is the impact of patent expiration on SUMAVEL DOSEPRO?
A4: Patent expiration typically opens the market to generic or biosimilar competitors, reducing exclusivity and pressuring prices, which can accelerate revenue decline unless strategic IP protections are pursued.

Q5: What are the prospects for the continued use of SUMAVEL DOSEPRO in the evolving migraine treatment landscape?
A5: While still valuable for specific patient groups, its future hinges on innovation and adaptation to emerging preferences, with prospects diminishing unless strategic updates are made.

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References

[1] IQVIA Institute. “The Global Migraine Market Report,” 2022.
[2] U.S. Food & Drug Administration. “Summary of FDA Approvals for Migraine,” 2009.
[3] MarketWatch. “Migraine Drugs Market Size, Trends & Forecast,” 2022.
[4] European Medicines Agency. “Review of Autoinjector Devices,” 2021.
[5] Industry Reports. “Device Innovation in Migraine Therapies,” 2022.