VYLEESI (AUTOINJECTOR) Drug Patent Profile

When do Vyleesi (autoinjector) patents expire, and what generic alternatives are available?

Vyleesi (autoinjector) is a drug marketed by Cosette and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-one patent family members in twenty-six countries.

The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. Two suppliers are listed for this compound. Additional details are available on the bremelanotide acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyleesi (autoinjector)

Vyleesi (autoinjector) was eligible for patent challenges on June 21, 2023.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VYLEESI (AUTOINJECTOR)

International Patents:	81
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYLEESI (AUTOINJECTOR)
DailyMed Link:	VYLEESI (AUTOINJECTOR) at DailyMed

Pharmacology for VYLEESI (AUTOINJECTOR)

Drug Class	Melanocortin Receptor Agonist
Mechanism of Action	Melanocortin Receptor Agonists

US Patents and Regulatory Information for VYLEESI (AUTOINJECTOR)

VYLEESI (AUTOINJECTOR) is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	9,352,013
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	10,286,034
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	11,590,209
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	9,700,592
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	6,794,489		Y	Y

Expired US Patents for VYLEESI (AUTOINJECTOR)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019	6,579,968
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019	6,794,489

International Patents for VYLEESI (AUTOINJECTOR)

See the table below for patents covering VYLEESI (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006014559
Canada	2376978	COMPOSITIONS ET METHODES DE TRAITEMENT DE DYSFONCTIONNEMENTS SEXUELS (COMPOSITIONS AND METHODS FOR TREATMENT OF SEXUAL DYSFUNCTION)
Canada	2573142
Japan	2008500369
World Intellectual Property Organization (WIPO)	0100224
Brazil	0012200	composição de peptídeo para o tratamento de disfunção sexual e composição farmacêutica para o tratamento de disfunção sexual em um mamífero.
Japan	2008505917

Market Dynamics and Financial Trajectory for VYLEESI (Autoinjector)

Last updated: July 27, 2025

Introduction

VYLEESI, an innovative autoinjector, signifies a significant advancement in self-administered therapies within the pharmaceutical landscape. Its development aligns with growing demand for patient-centric delivery systems, particularly in chronic diseases and autoimmune disorders. Analyzing its market dynamics and financial trajectory involves evaluating competitive positioning, technological innovation, regulatory landscape, and evolving healthcare trends. This comprehensive assessment enables stakeholders to gauge its commercial potential and strategic pathways.

Market Overview and Drivers

Growing Demand for Autoinjectors

Autoinjectors have revolutionized drug delivery by offering simplified, quick, and less painful administration, enhancing patient adherence. The global autoinjector market was valued at approximately USD 3.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 12% through 2030, driven by increased adoption in autoimmune disorders, multiple sclerosis, rheumatoid arthritis, and emergency medicine (source: MarketWatch).

Rising Incidence of Chronic Diseases

The rising prevalence of chronic conditions necessitating injectables significantly influences the autoinjector market. For example, multiple sclerosis affects over 2.8 million individuals worldwide, many of whom require regular self-injections. The convenience of autoinjectors like VYLEESI addresses barriers such as injection anxiety, ease of use, and portability.

Advances in Drug Formulation and Biologics

Increased adoption of biologics and peptide-based therapies, often requiring subcutaneous delivery, further bolsters demand for sophisticated autoinjectors. VYLEESI's compatibility with such formulations positions it favorably in this expanding therapeutic area.

Regulatory and Reimbursement Environment

Regulatory support for electronic and digitally connected injection devices fosters innovation. Additionally, positive reimbursement policies for self-injection devices incentivize manufacturers and healthcare systems to favor advanced autoinjectors.

Competitive Landscape

VYLEESI entered a competitive landscape populated by established players (e.g., Amgen’s Nexpenza, Biogen’s Tecfidera autoinjector systems) and emerging innovators. Its success hinges on key differentiators:

• Technological edge: VYLEESI's user-friendly interface, safety features, and connectivity options (e.g., data tracking, reminders).
• Regulatory status: Pending or granted FDA and EMA approvals influence market entry speed.
• Partnerships: Collaborations with pharmaceutical firms enhance market penetration.
• Patents and IP: Strong intellectual property shield VYLEESI from generic competition initially.

Financial Trajectory

Revenue Projections and Market Penetration

Given the substantial market size and rising adoption, VYLEESI's revenue potential is significant. For perspective, a new autoinjector targeting autoimmune therapies could capture roughly 10-15% of the annual USD 3.5 billion market within five years, translating to USD 350-525 million annually by 2028.

Initial revenues are likely modest during the launch phase, focusing on early adopters and pilot programs. As regulatory approvals are secured and manufacturing scales up, revenues could accelerate. The revenue stream will derive from device sales, minimum subscription/license fees, and potentially digital health services embedded within the device.

Cost Structure and Profitability

Manufacturing costs for autoinjector devices are declining with advancements in microfabrication and automation. Nonetheless, R&D investments, regulatory fees, and marketing expenses remain significant initial outlays. Profit margins depend on economies of scale, device pricing strategies (premium vs. competitive), and reimbursement negotiations.

Strategic Growth and Investment

VYLEESI's financial trajectory benefits from strategic partnerships with pharmaceutical companies aiming to embed the device into their therapeutics. Investment in digital health integration and data-driven services opens avenues for subscription-based revenue models, enhancing profitability and customer retention.

Risks and Challenges

Potential hurdles include delays in regulatory approval, pricing and reimbursement barriers, market acceptance, and competitive pressures from established players or alternative delivery systems (e.g., patches, oral biologics).

Regulatory and Market Access Considerations

Regulatory approvals are pivotal for commercial success. VYLEESI must demonstrate device safety, reliability, and interoperability with various drug formulations. Market access strategies should focus on engaging payers early and demonstrating value through improved patient adherence and reduced healthcare costs.

Future Outlook and Trends

Predicted growth trajectories for VYLEESI depend heavily on:

• Regulatory milestones: Faster approvals expedite revenue realization.
• Integration into therapeutics: Partnerships with pharma companies facilitate clinical adoption.
• Digital health capabilities: Data connectivity enhances patient engagement and brand differentiation.
• Global reach: Expanding beyond North America and Europe to emerging markets broadens revenue base.

Conclusion

VYLEESI’s market dynamics are characterized by robust growth drivers rooted in technological innovation, rising chronic disease prevalence, and patient preference shifts. Its financial outlook is promising, contingent upon regulatory success, strategic partnerships, and effective market access. Stakeholders should prioritize accelerating regulatory pathways, fostering collaborations, and investing in digital integration to maximize its commercial and therapeutic impact.

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Key Takeaways

• The global autoinjector market is growing rapidly, with CAGR approximately 12%, driven by chronic disease management and biologics.
• VYLEESI’s differentiation through user-friendly features and digital connectivity positions it favorably.
• Market penetration hinges on regulatory approvals, partnerships, and reimbursement strategies.
• Revenue potential could reach USD 350-525 million annually within five years, depending on adoption rates.
• Innovation in digital health and global expansion are critical to sustained financial growth.

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FAQs

Q1: What factors influence VYLEESI's market adoption?
Regulatory approval, competitive differentiation, partnerships with pharmaceutical companies, reimbursement policies, and patient acceptance significantly impact adoption.

Q2: How does VYLEESI compare to existing autoinjectors?
VYLEESI offers enhanced usability, safety features, and digital health integration, setting it apart from traditional devices with basic injection functions.

Q3: What are the primary risks to VYLEESI’s financial trajectory?
Regulatory delays, market resistance, high manufacturing costs, competitive innovations, and reimbursement challenges could hinder growth.

Q4: How can VYLEESI leverage digital health?
Integrating Bluetooth or telemetry features allows tracking injections, reminding patients, and collecting adherence data, adding value for both patients and providers.

Q5: What is the strategic importance of partnerships for VYLEESI?
Collaborations with pharma firms facilitate clinical integration, streamline manufacturing, and enhance market reach, crucial for scaling revenues.

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Sources

1. MarketWatch. Autoinjector Market Size, Share & Trends Analysis, 2022-2030.
2. GlobalAutoInjectorsReport. (2022). Recent Advances and Market Outlook.
3. FDA Regulatory Approvals for Autoinjector Devices. (2022).
4. IMS Health Data. Global Autoimmune Disease Prevalence. (2022).
5. Industry Interviews and Strategic Partnership Announcements (2022-2023).