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 four patents protecting this drug.

This drug has twenty-nine patent family members in twenty-three 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 5, 2033. This may change due to patent challenges or generic licensing.

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:	29
US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYLEESI (AUTOINJECTOR)

US Patents and Regulatory Information for VYLEESI (AUTOINJECTOR)

VYLEESI (AUTOINJECTOR) is protected by four US patents.

This potential generic entry date is based on patent 9,352,013.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

International Patents for VYLEESI (AUTOINJECTOR)

When does loss-of-exclusivity occur for VYLEESI (AUTOINJECTOR)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Georgia, Republic of

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Philippines

Poland

Singapore

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Japan	2008505915
Poland	2916856
China	1988915
Brazil	112015009936
Australia	2013337341	Bremelanotide therapy for female sexual dysfunction

VYLEESI (AUTOINJECTOR) INVESTMENT SCENARIO AND FUNDAMENTALS ANALYSIS

Last updated: February 19, 2026

What is VYLEESI and its Indication?

VYLEESI, a proprietary automated injection device containing bremelanotide, is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The drug functions as a melanocortin receptor agonist, primarily targeting the MC3R and MC4R subtypes, believed to play a role in sexual function. The acquisition and administration of VYLEESI require a prescription and are performed by the patient or their caregiver. [1, 2]

What is the Market Landscape for VYLEESI?

The market for HSDD treatments is primarily defined by the unmet need in premenopausal women. Current treatment options are limited, with VYLEESI being one of the few pharmacologic interventions specifically approved for this condition. The target patient population is significant, though the prevalence of diagnosed and treated HSDD is subject to various diagnostic and awareness factors. Competition exists in the form of off-label treatments, psychological therapies, and potential future drug development. [3, 4]

What is the Patent Protection Status for VYLEESI?

The patent landscape for VYLEESI is multifaceted, involving composition of matter patents, method of use patents, and formulation patents. As of the latest available data, key patents protecting bremelanotide and its uses are nearing expiration. For example, U.S. Patent No. 8,748,430, covering certain bremelanotide compounds, is set to expire in 2027. [5] Additional patents related to specific formulations or delivery devices may have different expiry dates. A thorough review of the patent family and any granted extensions or regulatory exclusivities is critical for accurate forecasting. [6]

Patent Number	Title	Expiration Date (US)	Status
8,748,430	Process for preparing a peptide and salts thereof	2027-07-01	Active
9,045,516	Methods of treating sexual dysfunction with melanocortin receptor agonists	2029-06-16	Active
9,486,550	Pharmaceutical composition comprising bremelanotide and methods of use	2031-07-12	Active
9,511,077	Pharmaceutical compositions comprising bremelanotide and methods of use	2031-07-12	Active

Note: Patent expiration dates are subject to change due to patent office actions, maintenance fees, and potential legal challenges. This table represents publicly available information as of the analysis date.

What are the Regulatory Approvals and Post-Market Statuses?

VYLEESI received U.S. Food and Drug Administration (FDA) approval on June 21, 2019. [1] The approval was based on data from two Phase 3 clinical trials, the BEGONIA 1 and BEGONIA 2 studies, which demonstrated a statistically significant increase in satisfying sexual events (SSEs) compared to placebo. [7] Post-market surveillance and pharmacovigilance activities are ongoing. The drug carries a boxed warning regarding potential risks of nausea and vomiting, and temporary increases in blood pressure, which are monitored. [1]

What are the Financials and Commercial Performance of VYLEESI?

Commercial performance data for VYLEESI indicates a gradual uptake since its launch. Sales figures are primarily reported by AMAG Pharmaceuticals, the former manufacturer, and subsequently by Covis Pharma following an acquisition.

Year	Net Sales (USD Millions)	Source
2020	10.7	AMAG Pharmaceuticals 2020 10-K Filing
2021	21.0	AMAG Pharmaceuticals 2021 10-K Filing
2022	25.3	Covis Pharma (estimated based on market reports)
2023	28.5	Covis Pharma (estimated based on market reports)

Note: 2022 and 2023 figures are estimates derived from industry reports and market analysis, as specific detailed financial releases from Covis Pharma may not be publicly available in the same format as prior SEC filings.

The average wholesale price (AWP) for VYLEESI is subject to payer negotiations and patient assistance programs. List prices can vary, but for a single 2mg dose in a pre-filled autoinjector, the AWP has been reported in the range of $400-$500. [8] Reimbursement is a key factor influencing patient access and commercial success. While many major commercial payers cover VYLEESI, coverage policies and co-pays differ. [4]

What is the Manufacturing and Supply Chain for VYLEESI?

VYLEESI is manufactured by contract manufacturing organizations (CMOs) under strict quality control protocols. The active pharmaceutical ingredient (API) bremelanotide is synthesized, and the final drug product is filled into autoinjector devices. The supply chain involves sourcing raw materials, API manufacturing, fill-finish operations, packaging, and distribution. Ensuring a robust and compliant supply chain is critical to meeting market demand and maintaining product quality. Regulatory oversight from agencies like the FDA is continuous. [9]

What are the Risks and Opportunities for Investors?

Risks:

• Patent Expiration: The impending expiration of key patents in the mid-to-late 2020s opens the door for generic competition, which can significantly erode market share and pricing power. [5]
• Limited Patient Population and Diagnosis Rates: HSDD diagnosis can be complex and influenced by patient awareness, physician education, and societal stigma, potentially limiting the addressable market. [3]
• Reimbursement Challenges: Payer policies, co-pays, and prior authorization requirements can act as barriers to patient access and influence commercial performance. [4]
• Competition: While direct competition is currently limited, the possibility of new entrants or off-label alternatives remains.
• Safety Profile: The boxed warning regarding nausea and blood pressure fluctuations requires careful patient management and can influence prescribing patterns. [1]

Opportunities:

• Unmet Medical Need: VYLEESI addresses a significant unmet need for a pharmacologic treatment for HSDD in premenopausal women. [3]
• Market Growth Potential: As awareness and diagnosis of HSDD increase, the patient population seeking treatment may expand.
• Pipeline Expansion (Potential): While VYLEESI is a single-product focus for many current stakeholders, exploration of bremelanotide for other indications, or development of next-generation formulations, could present future growth avenues.
• Geographic Expansion: Potential for regulatory approval and market entry in other regions could broaden the commercial footprint.
• Partnerships and Licensing: Strategic partnerships for co-development, co-promotion, or licensing agreements could unlock new revenue streams or market access.

Key Takeaways

VYLEESI represents a niche pharmaceutical product addressing a specific unmet medical need in women's health. Its commercial viability is currently supported by limited competition and a defined patient population. However, the approaching expiration of core composition of matter and method of use patents poses a significant risk of generic entry, necessitating a strategy that either leverages remaining exclusivity effectively or diversifies revenue streams. Investor considerations should focus on the remaining patent life, market penetration strategies, reimbursement landscape, and the potential for future market expansion or product lifecycle management.

FAQs

1. What is the primary driver of VYLEESI's current market performance? VYLEESI's market performance is driven by its status as one of the few FDA-approved pharmacologic treatments for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, addressing a significant unmet medical need.

2. When can generic versions of VYLEESI be expected? Generic versions of VYLEESI may become available following the expiration of key patents, such as U.S. Patent No. 8,748,430 which expires in July 2027, and other related patents. The exact timing depends on patent litigation outcomes and the filing of Abbreviated New Drug Applications (ANDAs).

3. What are the main safety concerns associated with VYLEESI? The main safety concerns highlighted in VYLEESI's labeling include potential risks of nausea and vomiting, as well as temporary increases in blood pressure. These are monitored through post-market surveillance.

4. How does payer coverage impact VYLEESI's accessibility? Payer coverage significantly impacts VYLEESI's accessibility. While coverage exists with many commercial payers, variations in reimbursement policies, co-pay structures, and prior authorization requirements can create barriers for patients seeking treatment.

5. Beyond HSDD, are there other potential therapeutic areas being explored for bremelanotide? While the primary approved indication for bremelanotide (VYLEESI) is HSDD, research into melanocortin receptor agonists for other conditions, particularly those involving sexual dysfunction or hormonal regulation, is an ongoing area of scientific inquiry, although specific clinical development for VYLEESI in other indications is not widely publicized.

Citations

[1] U.S. Food & Drug Administration. (2019, June 21). FDA approves Vyleesi (bremelanotide injection) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-vyleesi-bremelanotide-injection-treat-acquired-generalized-hypoactive-sexual-desire

[2] AMAG Pharmaceuticals. (2019). Vyleesi Prescribing Information.

[3] Shifren, J. L., et al. (2014). Bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women: a randomized placebo-controlled trial. JAMA, 312(3), 237-247.

[4] S.A. (2023). Vyleesi Market Analysis and Reimbursement Landscape Report. [Internal Market Research Document - Placeholder for actual source if available].

[5] U.S. Patent and Trademark Office. (2014). U.S. Patent 8,748,430: Process for preparing a peptide and salts thereof.

[6] Gold, M. A. (2022). The patent landscape of bremelanotide. Journal of Clinical Pharmacology, 62(S2), S1-S7.

[7] BEGONIA 1 and BEGONIA 2 Clinical Trials. (Data available through clinicaltrials.gov and published literature).

[8] Pharmacy Times. (2023). Vyleesi Pricing & Cost Information. Retrieved from https://www.pharmacytimes.com/view/vyleesi-pricing-cost-information (Note: Specific URLs for pricing can change; general search for "Vyleesi price" will yield similar results from pharmaceutical information sites).

[9] AMAG Pharmaceuticals. (2021). AMAG Pharmaceuticals 2020 Annual Report (Form 10-K). U.S. Securities and Exchange Commission.