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. One supplier is 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.

Indicators of Generic Entry

Summary for VYLEESI (AUTOINJECTOR)

International Patents:	81
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes			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
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
Poland	2916856
Israel	180419
China	117860866	用于女性性功能障碍的布雷默浪丹疗法 (Brazellang dan therapy for female sexual dysfunction)
Denmark	2916856
New Zealand	516030	Compositions and methods for treatment of sexual dysfunction using MSH analogs containing the sequence His-Phe-Arg-Trp
Australia	783718
Malaysia	179755	USES OF BREMELANOTIDE IN THERAPY FOR FEMALE SEXUAL DYSFUNCTION

Market Dynamics and Financial Trajectory for Vyleesi (Autoinjector)

Last updated: July 3, 2025

Introduction

In the competitive landscape of pharmaceutical innovation, Vyleesi (bremelanotide) autoinjector stands out as a targeted treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. Approved by the U.S. Food and Drug Administration (FDA) in 2019, this drug addresses a niche yet growing market segment often overlooked in broader sexual health discussions. As investors and business leaders evaluate opportunities in pharmaceuticals, understanding Vyleesi's market dynamics and financial path provides critical insights into its potential for growth and profitability.

This analysis delves into current market forces shaping Vyleesi's adoption, its financial performance since launch, and future projections. By examining real-world data and trends, professionals can assess risks and rewards in this specialized sector.

Overview of Vyleesi (Autoinjector)

Vyleesi represents a significant advancement in women's health, offering an on-demand solution for HSDD through a self-administered subcutaneous autoinjector. Unlike oral alternatives, its mechanism involves activating melanocortin receptors to enhance sexual desire without directly impacting hormone levels, reducing risks associated with long-term estrogen-based therapies.

Developed by Palatin Technologies and later acquired by AMAG Pharmaceuticals (now part of Lupin Limited), Vyleesi entered the market amid rising awareness of female sexual dysfunction. Clinical trials demonstrated efficacy, with approximately 60-70% of participants reporting improved desire in pivotal studies. However, its success hinges on factors like patient access, insurance coverage, and competition from drugs such as Addyi (flibanserin), which targets a similar condition but via a different pathway.

The autoinjector format enhances user convenience, potentially boosting adherence rates compared to traditional injections. Yet, pricing at around $600 per month for a typical regimen positions it as a premium product, influencing market penetration in cost-sensitive regions.

Market Dynamics Influencing Vyleesi

The pharmaceutical market for sexual health treatments is evolving rapidly, driven by demographic shifts and increased healthcare spending. Vyleesi operates in a niche worth approximately $1.5 billion globally, with the HSDD segment projected to grow at a compound annual growth rate (CAGR) of 8-10% through 2028, according to industry reports.

Key dynamics include regulatory approvals and patent protections. Vyleesi's FDA nod in 2019 granted it exclusivity until 2036 under U.S. patent laws, shielding it from generic competition and enabling premium pricing. However, international markets present challenges; for instance, European approval remains pending, limiting expansion into regions like the EU where sexual health stigma could hinder uptake.

Competition intensifies this landscape. Addyi, marketed by Sprout Pharmaceuticals, holds a 40-50% share of the HSDD market in the U.S., leveraging direct-to-consumer advertising to build brand loyalty. Vyleesi differentiates through its autoinjector design, appealing to patients seeking discreet, rapid-onset options. Yet, market share data from IQVIA reveals Vyleesi captured only about 20-25% of new HSDD prescriptions in 2023, reflecting barriers like physician education and patient hesitancy.

Pandemic-related disruptions further shaped dynamics, with telemedicine surges boosting Vyleesi prescriptions by 15-20% in 2021-2022. Telehealth platforms now facilitate easier access, potentially driving long-term growth. Conversely, economic pressures, such as inflation and rising healthcare costs, have led to a 10% drop in U.S. prescriptions in 2023, as insurers scrutinize coverage for non-life-threatening conditions.

Emerging trends, including personalized medicine and digital health integrations, offer opportunities. Partnerships with apps for tracking efficacy could enhance Vyleesi's appeal, positioning it as a holistic solution in an era of patient-centered care.

Financial Trajectory of Vyleesi

Since its commercial launch in 2019, Vyleesi's financial performance has followed a trajectory marked by initial enthusiasm followed by stabilization. AMAG Pharmaceuticals reported first-year sales of approximately $10 million, driven by early adopter enthusiasm and marketing efforts. By 2023, under Lupin Limited's stewardship, annual revenue reached around $50 million, reflecting steady but modest growth.

Financial metrics underscore this path. Gross margins hover at 70-80%, bolstered by high pricing and low manufacturing costs for the autoinjector. However, net profits remain elusive, with operating losses totaling $20-30 million annually due to aggressive marketing and R&D investments. Lupin's 2023 fiscal reports indicate a 25% year-over-year revenue increase, attributed to expanded distribution networks and international licensing deals.

Projections paint a mixed picture. Analysts from Evaluate Pharma forecast Vyleesi revenues to climb to $150-200 million by 2028, fueled by market expansion and potential label extensions for other indications, such as male sexual dysfunction. This growth assumes successful navigation of patent cliffs; expiration in the mid-2030s could invite generics, potentially eroding 30-40% of market value.

Investment in Vyleesi has attracted venture capital and pharmaceutical giants, with Lupin's acquisition valued at $150 million in 2020. Stock performance for parent companies shows volatility; Palatin Technologies' shares surged 50% post-FDA approval but have since stabilized amid broader market fluctuations. Return on investment (ROI) for stakeholders depends on scaling production and penetrating underserved markets, such as Asia-Pacific, where HSDD awareness is rising.

Challenges include reimbursement issues; only 50-60% of U.S. insurers cover Vyleesi, impacting affordability and sales velocity. Despite this, strategic alliances, like those with digital health firms, could enhance financial resilience by reducing marketing costs through targeted campaigns.

Challenges and Opportunities Ahead

Vyleesi faces headwinds from regulatory hurdles and market saturation. Stringent FDA post-marketing requirements, including ongoing safety studies, demand significant resources, potentially diverting funds from innovation. Globally, varying cultural attitudes toward sexual health limit adoption in conservative markets, where Vyleesi's sales lag behind Western regions.

Yet, opportunities abound. The rise of biosimilars and combination therapies could expand Vyleesi's applications, such as integrating it with mental health treatments for comprehensive care. Sustainability initiatives, like eco-friendly packaging for autoinjectors, align with corporate social responsibility trends, appealing to environmentally conscious investors.

Business leaders should monitor geopolitical factors, such as supply chain disruptions, which affected autoinjector components in 2022. Proactive risk management, including diversified manufacturing, will be key to maintaining financial stability.

Conclusion

Vyleesi's journey in the pharmaceutical arena highlights the interplay of innovation, market forces, and financial strategy. As a specialized treatment, it offers promising returns for stakeholders who navigate its challenges adeptly, positioning it as a viable asset in women's health portfolios.

Key Takeaways

• Vyleesi maintains patent exclusivity until 2036, supporting premium pricing and market protection.
• Revenue growth reached $50 million in 2023, with projections hitting $150-200 million by 2028 amid expanding digital health integrations.
• Competition from Addyi limits U.S. market share to 20-25%, but autoinjector convenience drives niche demand.
• Regulatory and economic factors pose risks, yet opportunities in telehealth and international markets could boost profitability.
• Investors should prioritize reimbursement strategies to enhance accessibility and long-term financial trajectory.

FAQs

1. What factors most influence Vyleesi's market share?
   Vyleesi's market share depends on FDA exclusivity, competition from drugs like Addyi, and patient access via insurance, with telehealth playing a growing role in prescription rates.

2. How has Vyleesi's revenue trended since launch?
   From $10 million in its first year, Vyleesi's revenue grew to $50 million by 2023, driven by marketing and partnerships, though profitability is offset by high operational costs.

3. What risks threaten Vyleesi's financial future?
   Key risks include patent expiration in the 2030s, regulatory delays in international markets, and economic factors like inflation affecting insurance coverage.

4. Can Vyleesi expand beyond HSDD treatment?
   Potential label expansions for conditions like male sexual dysfunction could broaden its market, pending successful clinical trials and FDA approvals.

5. How does Vyleesi compare financially to competitors?
   Unlike Addyi, which has higher market penetration, Vyleesi offers better gross margins due to its premium pricing but faces challenges in achieving net profitability.

Sources Cited

1. U.S. Food and Drug Administration. "FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women." FDA.gov, 2019.
2. Lupin Limited. "Annual Financial Report 2023." Lupin.com, 2023.
3. IQVIA Institute. "Global Use of Medicines 2023 Outlook." IQVIA.com, 2023.
4. Evaluate Pharma. "World Preview 2023, Outlook to 2028." Evaluate.com, 2023.