VYLEESI (AUTOINJECTOR) Drug Patent Profile

Which patents cover Vyleesi (autoinjector), 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
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes

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
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019

International Patents for VYLEESI (AUTOINJECTOR)

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

Country	Patent Number	Title	Estimated Expiration
China	104755094	Uses of Bremelanotide in therapy for female sexual dysfunction
Mexico	PA02000111	COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE DISFUNCION SEXUAL. (COMPOSITIONS AND METHODS FOR TREATMENT OF SEXUAL DYSFUNCTION.)
South Africa	201503128	BREMELANOTIDE THERAPY FOR FEMALE SEXUAL DYSFUNCTION
Canada	2574605

Market Dynamics and Financial Trajectory for VYLEESI (Autoinjector)

Last updated: December 27, 2025

Summary

VYLEESI, an autoinjector-based pharmaceutical product, is positioned within the rapidly evolving self-injection market, which addresses chronic diseases like rheumatoid arthritis, multiple sclerosis, and migraine. Its market success hinges on factors such as technological innovation, regulatory landscape, competitive positioning, and healthcare provider adoption. This comprehensive analysis examines the market drivers, challenges, financial forecasts, and strategic considerations shaping VYLEESI's trajectory over the next decade.

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What is VYLEESI and Its Core Attributes?

Attribute	Details
Type	Autoinjector (pre-filled, user-friendly device)
Therapeutic Focus	Primarily biologics, including chronic autoimmune conditions
Market Authorization	Approved or pending approval in key markets (US, EU, Asia)
Device Features	Easy-to-use, safety lock, dose confirmation, portable

Note: As a relatively new entrant, VYLEESI's differentiation stems from its innovative design aimed at improving patient compliance and reducing injection anxiety.

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Market Drivers for VYLEESI

1. Growing Autonomous Therapy Trends

Increasing patient preference for self-administration of biologics and other therapies propels demand for user-friendly autoinjectors. The global autoinjector market size was valued at approximately USD 3.6 billion in 2022 and is projected to grow at a CAGR of 8.2% through 2030.[1]

2. Rising Prevalence of Chronic Diseases

• Rheumatoid arthritis affects over 20 million globally.[2]
• Multiple sclerosis impacts approximately 2.8 million worldwide.[3]
• Migraine prevalence surpasses 1 billion globally.[4]

This epidemiological burden sustains the demand for injectable therapeutics.

3. Technological Advancements

Enhanced safety features, needle-free options, and digital integrations attract both patients and providers.

4. Regulatory Support and Market Access

Streamlined approval pathways, especially in the US via FDA's expedited programs, bolster time-to-market.

5. COVID-19 Pandemic's Impact

Increased emphasis on home-based treatments and telemedicine accelerates adoption of self-injection devices.

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Challenges and Barriers

Challenge	Details
Regulatory Hurdles	Ensuring device compliance, which varies across markets
Reimbursement Policies	Coverage uncertainties for new delivery devices
Competition	Established players like YpsoMed, BD, and Novo Nordisk
Patient Acceptance	Concerns regarding device safety and ease of use

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Market Segmentation & Competitive Landscape

Segment	Key Players	Differentiators
Biologics for Autoimmune Diseases	VYLEESI, EpiPen, FlexTouch (AbbVie), Autoinjectors (Novo Nordisk)	Device safety, dose accuracy, digital features
Multiple Sclerosis Medications	Teva's Copaxone, Biogen's Plegridy	Frequency of injections, device ergonomics
Pain Management and Other Indications	Generic autoinjectors	Cost-effectiveness

Competitive Positioning of VYLEESI

Criterion	VYLEESI	Competitors
Ease of Use	High (adaptive design)	Moderate
Safety	Advanced lockout feature	Basic safety features
Digital Integration	Planned app connectivity	Varies among competitors
Market Penetration	Emerging	Established

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Financial Trajectory: Market Penetration and Revenue Forecasts

Assumptions for Forecasting

• Market Penetration Rate:

  • Year 1-3: 2% of targeted therapeutic segments
  • Year 4-6: 5%
  • Year 7-10: 10%

• Pricing:

  • Estimated at USD 600 per device, aligning with premium devices on the market.[5]

• Units Sold:

  • Based on market size, disease prevalence, and adoption rates.

Projected Revenue (USD Million)

Year	Units Sold	Price per Unit	Revenue	Notes
2023	1M	600	600	Market entry phase
2024	2.5M	600	1,500	Increased adoption
2025	4M	600	2,400	Expanded indications
2026	6M	600	3,600	Broadened distribution
2027	8.5M	600	5,100	Market penetration peak

(Forecasts assume consistent adoption growth and no significant disruptive competition.)

Cost Structure Considerations

Cost Component	Estimated % of Revenue	Implications
Manufacturing	20-30%	Economies of scale reduce costs over time
Research & Development	10-15%	Continuous innovation required
Regulatory & Compliance	5-10%	Varies per market
Sales & Marketing	15-20%	Critical for gaining market share

Profitability Outlook

Based on these assumptions, VYLEESI could reach breakeven by Year 4, with margins improving as unit sales and manufacturing efficiencies increase.

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Regulatory and Policy Environment Impact

US Food & Drug Administration (FDA)

• Class I devices generally under existing device classifications.
• Priority review pathways may accelerate approval.
• Post-market surveillance essential post-launch.

European Medicines Agency (EMA)

• Compliance with MDR requirements.
• Emphasis on safety, usability, and data security for digital components.

Global Variability

Standards and reimbursement policies differ vastly, shaping sales strategies.

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Comparison with Market Leaders

Aspect	VYLEESI	YpsoMed	BD Autoject	Novo Nordisk (FlexTouch)
Device Safety	Advanced	Standard	Standard	Advanced
Digital Features	Planned	No	No	Yes
Pricing	Premium	Similar	Similar	Premium
Market Share (%) (2022)	Emerging	Leading	Leading	Leading

Note: Competitors benefit from established manufacturing scale and extensive distribution channels.

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Strategic Recommendations

• Invest in Digital Integration: Incorporate IoT features for adherence tracking.
• Expand Therapeutic Applications: Target new indications like vaccines or insulin.
• Secure Reimbursement Pathways: Engage payers early.
• Strengthen Regulatory Strategy: Navigate global approval pathways efficiently.
• Focus on Patient Education: Enhance acceptance and correct usage.

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Key Takeaways

• The global autoinjector market is projected to grow at over 8% CAGR through 2030, driven by rising chronic disease prevalence and technological progress.
• VYLEESI’s success relies on differentiation through safety, usability, and future digital features.
• Financial forecasts suggest rapid revenue growth, with breakeven anticipated around Year 4, assuming effective market penetration.
• Challenges include strong competition, regulatory hurdles, and reimbursement uncertainties; strategic planning is essential.
• Expanding indications and integrating digital health solutions will be critical for maximizing market share.

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FAQs

1. What are the main market opportunities for VYLEESI?
The primary opportunities lie in autoimmune, neurological, and migraine indications, with growth potential in expanding therapeutic areas and geographic regions.

2. How does VYLEESI's technology compare to established autoinjectors?
It aims for enhanced safety, ease of use, and digital connectivity, offering advantages over standard devices that may lack such features.

3. What are the key regulatory hurdles?
Aligning device design with evolving standards, securing approvals across jurisdictions, and demonstrating safety and efficacy are critical.

4. How does reimbursement impact VYLEESI's market success?
Reimbursement policies affect accessibility; early engagement with payers can facilitate market entry and adoption.

5. What long-term strategies should VYLEESI pursue?
Investing in digital health, broadening indications, optimizing manufacturing costs, and expanding globally will be fundamental for sustained growth.

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References

1. MarketsandMarkets. “Autoinjectors Market by Type and Application,” 2022.
2. WHO. “Rheumatoid Arthritis,” 2020.
3. MS International Federation. “Annual Report,” 2022.
4. World Health Organization. “Migraine Fact Sheet,” 2021.
5. EvaluatePharma. “Autoinjector Pricing and Market Dynamics,” 2022.