VYLEESI (AUTOINJECTOR) Drug Patent Profile

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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 four patents protecting this drug.

The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. There is one drug master file entry for this compound. 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.

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)

US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	13
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYLEESI (AUTOINJECTOR)
DailyMed Link:	VYLEESI (AUTOINJECTOR) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VYLEESI (AUTOINJECTOR)

NDA:

210557

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 four US patents.

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
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)

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
Australia	2013337341
Brazil	112015009936
Canada	2890081
China	104755094

Vyleesi Autoinjector Market Dynamics, Patent Estate, Exclusivity and Financial Trajectory

Last updated: October 5, 2026

Vyleesi, the brand name for bremelanotide injection, is an FDA-approved on-demand treatment for acquired, generalized hypoactive sexual desire disorder in premenopausal women. The product launched in 2019 but generated limited commercial momentum under AMAG Pharmaceuticals. Commercial ownership later moved to Cosette Pharmaceuticals, a private company, which limits current revenue visibility. Vyleesi’s main market constraints are a narrow labeled population, injectable administration, dosing restrictions, modest payer coverage, and competition from oral Addyi.

The product remains commercially relevant because it has no direct generic or biosimilar substitute currently marketed in the United States. Its primary protection comes from formulation, delivery-device, and method-of-use rights rather than from a broad composition-of-matter monopoly.

What is Vyleesi and how does the autoinjector work?

Vyleesi contains bremelanotide, a melanocortin receptor agonist administered subcutaneously through a single-dose autoinjector. The FDA approved the product on June 21, 2019, under NDA 210557 for acquired, generalized HSDD in premenopausal women that is not caused by a coexisting medical or psychiatric condition, relationship problems, or medication effects (FDA, 2019).

The labeled dose is 1.75 mg injected at least 45 minutes before anticipated sexual activity. Patients may use no more than one dose within 24 hours and no more than eight doses per month. Treatment should be discontinued after eight weeks if there is no improvement in sexual desire or distress associated with low desire.

Product attribute	Vyleesi specification
Active ingredient	Bremelanotide
Dosage form	Subcutaneous injection
Delivery	Single-dose prefilled autoinjector
Strength	1.75 mg per dose
FDA application	NDA 210557
Approval date	June 21, 2019
Labeled population	Premenopausal women with acquired, generalized HSDD
Maximum use	One dose per 24 hours; eight doses per month
Primary competitor	Addyi, or flibanserin
Regulatory category	New drug, not a biologic

Vyleesi carries warnings concerning transient increases in blood pressure, focal hyperpigmentation, nausea, headache, vomiting, flushing and injection-site reactions. The product is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease (FDA, 2023).

How large is the Vyleesi market?

The addressable market is materially smaller than the broader population of women reporting low sexual desire. FDA approval is limited to premenopausal women with a specific diagnosis of acquired, generalized HSDD. This excludes postmenopausal women, men, patients with medication-induced dysfunction and many patients whose symptoms are linked to relationship, psychiatric or medical factors.

Market demand is shaped by four factors:

1. HSDD diagnosis and patient identification remain inconsistent.
2. Vyleesi requires self-injection before anticipated sexual activity.
3. Nausea and blood-pressure effects reduce persistence for some patients.
4. Insurance coverage and prior authorization restrict access.

Vyleesi has an advantage over Addyi because it is used on demand rather than daily. Addyi has broader brand recognition and an oral dosage form, but it also has dosing restrictions and alcohol-related warnings. The two products compete for the same specialist-prescribed HSDD population.

How does Vyleesi compare with Addyi?

Factor	Vyleesi	Addyi
Active ingredient	Bremelanotide	Flibanserin
Administration	Subcutaneous autoinjector	Oral tablet
Use pattern	On demand	Daily at bedtime
FDA population	Premenopausal women with acquired, generalized HSDD	Initially premenopausal women; labeling later expanded to include postmenopausal women
Principal adverse-effect concern	Nausea and transient blood-pressure elevation	Hypotension, syncope and central nervous system effects
Commercial ownership	Cosette Pharmaceuticals	Ownership has changed through multiple commercial entities
Product format	Injection device and drug combination	Oral solid dosage form

The on-demand format gives Vyleesi a practical differentiation point. The injection requirement limits its appeal relative to oral therapy, particularly among patients seeking low-friction treatment.

What is the financial trajectory for Vyleesi?

Vyleesi’s financial trajectory has been weaker than the initial commercial opportunity implied by its FDA approval. AMAG launched the product in 2019, but early demand was constrained by limited physician familiarity, access barriers and the COVID-19 disruption to in-person healthcare.

AMAG disclosed Vyleesi product revenue in its public filings, but the product did not become a major revenue contributor relative to the company’s other assets. AMAG was acquired by Covis Pharma in 2020. Commercial rights subsequently moved to Cosette Pharmaceuticals, which acquired Vyleesi from AMAG/Covis in 2022.

Period	Commercial event	Financial implication
2019	FDA approval and U.S. launch	Initial market formation; limited launch-year revenue
2020	AMAG ownership transition to Covis	Commercial continuity under new ownership
2021-2022	Rights transition to Cosette	Product moved to a private specialty-pharmaceutical platform
2022 onward	Cosette commercialization	No detailed public Vyleesi revenue series generally available
Current outlook	Mature niche product	Growth depends on access expansion, prescriber activation and repeat use

Because Cosette is privately held, current net sales, gross-to-net deductions, prescription volume, patient starts and operating profitability are not disclosed with the detail available for a public company. There is no reliable public basis to assign a current annual revenue figure without proprietary market data.

Vyleesi’s revenue model is likely driven more by refill persistence than by new-patient acquisition. The eight-dose monthly limit caps consumption per patient. That structure limits upside even if prescription volume grows. A higher-value commercial strategy would therefore focus on increasing diagnosis rates, reducing abandonment and improving insurance reimbursement rather than expanding dose volume.

Who owns Vyleesi and what licensing deals affect the product?

Palatin Technologies developed bremelanotide and was involved in the original commercialization structure. AMAG obtained U.S. commercial rights before launch. Following AMAG’s ownership changes, Cosette became the principal commercial owner of Vyleesi in the United States.

The ownership sequence is material because it shows repeated changes in commercialization strategy:

• Palatin originated the asset and retained economic interests through royalty and milestone arrangements.
• AMAG funded late-stage development and launched the product.
• Covis acquired AMAG and its portfolio.
• Cosette acquired Vyleesi for continued specialty-pharmaceutical commercialization.

The transaction history indicates that Vyleesi has been treated as a focused specialty asset rather than as a core platform product. Public disclosures do not establish a large current co-promotion network or a broad international commercialization footprint.

What patents protect Vyleesi?

Vyleesi is protected through a layered estate covering bremelanotide formulations, injectable delivery and therapeutic use. The practical protection is narrower than a classic early-filed composition-of-matter patent because bremelanotide is an established peptide sequence derived from melanocortin biology.

Relevant protection can include:

Protection category	Commercial role
Bremelanotide composition and analog rights	Protect the active peptide or related compounds
Injectable formulation patents	Protect concentration, excipients, stability and administration
Autoinjector or device rights	Protect the delivery mechanism and user interface
Method-of-use patents	Protect treatment of HSDD or related sexual dysfunction conditions
Manufacturing patents	Protect peptide synthesis, purification or formulation processes

The FDA Orange Book is the controlling source for patents listed against the approved NDA. Patent listings can change through corrections, delistings, litigation outcomes and regulatory submissions. The Vyleesi estate should therefore be assessed using the current Orange Book record rather than relying solely on historical patent databases (FDA, 2024a).

What are the likely patent expiration dates?

The later-expiring rights associated with formulation, delivery and method-of-use claims may extend beyond the basic chemical protection for bremelanotide. Patent-term adjustment, patent-term extension, terminal disclaimers and pediatric exclusivity can alter the effective date.

No single expiration date represents the entire Vyleesi estate. The relevant commercial question is whether a proposed generic can avoid each enforceable listed patent or obtain a judgment of invalidity or noninfringement.

A definitive freedom-to-operate review should examine:

• Every active Orange Book-listed patent for NDA 210557.
• Patent-family continuity and continuation claims.
• Terminal disclaimers.
• PTA and any PTE.
• Claim scope directed to the autoinjector rather than only the active ingredient.
• Foreign counterparts in target markets.

Are there Paragraph IV challenges to Vyleesi?

No widely reported, market-disrupting Paragraph IV challenge against Vyleesi had been established in the public record through the latest broadly available information. The absence of a public challenge does not establish that no ANDA certification has been submitted, because FDA Paragraph IV notices are generally disclosed through litigation filings, company releases or court records rather than through a complete public FDA database.

A generic challenger would face several possible pathways:

1. File an ANDA and certify against listed patents.
2. File a 505(b)(2) application relying partly on Vyleesi’s clinical and regulatory data.
3. Challenge formulation or method-of-use patents while designing around device claims.
4. Seek approval for a different presentation, such as a vial, syringe or alternative injector.

The autoinjector creates a potential barrier to simple substitution. A non-device generic could compete on price but would not be identical in user experience. Device patents and combination-product requirements may delay or complicate approval.

What is the FDA and Orange Book status of Vyleesi?

Vyleesi is FDA-approved under NDA 210557. It is a drug-device combination in practical use because the active ingredient is supplied through a prefilled autoinjector. The product is not a biologic and therefore does not face conventional biosimilar competition under the Public Health Service Act.

The Orange Book status matters for any generic applicant because FDA-listed patents may trigger a 30-month stay if the NDA holder brings infringement litigation after receiving a Paragraph IV notice. The absence of a confirmed public challenge means no established generic-entry timetable can be assigned.

Vyleesi’s regulatory protections are less significant than its patent protections. New chemical entity exclusivity associated with the 2019 approval has expired. Any remaining market protection depends mainly on listed patents, regulatory requirements, formulation complexity and commercial execution.

Is there biosimilar risk for Vyleesi?

Biosimilar risk is effectively not applicable. Bremelanotide is a synthetic peptide drug, not a licensed biologic. Competitive risk comes from generic or follow-on drug applications, compounded products, alternative formulations and competing HSDD therapies.

The more relevant technical barriers are:

• Peptide identity and purity.
• Stability in the finished dosage form.
• Device performance.
• Extractables and leachables.
• Dose-delivery accuracy.
• Human-factors validation.
• Combination-product manufacturing controls.

These requirements can raise development costs, but they do not necessarily prevent a well-capitalized generic company from entering after relevant patents expire or are successfully challenged.

What generic launch scenarios exist for Vyleesi?

At-risk launch before patent expiry

A generic company could launch before final patent resolution if it accepts infringement risk. This scenario would require a favorable risk-adjusted assessment of listed claims and likely litigation exposure. The probability is limited without a clear price opportunity and sufficient prescription volume.

First-filer launch after Paragraph IV litigation

A successful first filer could obtain 180-day generic exclusivity, depending on the applicable certification and forfeiture events. Vyleesi’s relatively small market may reduce the economic incentive to incur litigation costs unless the challenger can also pursue other bremelanotide indications or formulations.

Non-infringing formulation entry

A generic or 505(b)(2) applicant could develop a different container, injector or formulation. Such a product might avoid some device or formulation claims but would require its own regulatory and human-factors package.

Post-expiry entry

This is the lowest-risk route but may produce limited commercial value if the branded market has already contracted. The launch could still pressure price, particularly if payers treat the product as interchangeable or require lower net pricing.

How strong is the Vyleesi patent estate?

Vyleesi’s patent estate is best characterized as moderate rather than dominant.

Strengths include:

• A differentiated delivery system.
• Potentially later-expiring formulation and method-of-use claims.
• Regulatory complexity associated with an autoinjector.
• A narrow indication that may make direct clinical substitution less straightforward.

Weaknesses include:

• A restricted patient population.
• Limited prescription volume relative to major specialty drugs.
• The absence of a broad biologic exclusivity framework.
• Potential design-around opportunities.
• A commercial market that may not justify prolonged generic litigation.

Patent strength is therefore only one component of launch risk. The commercial value of the estate depends on whether the protected claims cover the commercially preferred presentation and whether Vyleesi generates enough profit to support enforcement.

What patent litigation and settlement risks affect Vyleesi?

No major publicly established Vyleesi patent settlement or final infringement judgment defines the market through the latest broadly available record. If a Paragraph IV case emerges, the principal issues are likely to involve:

• Whether the generic product uses the claimed formulation.
• Whether the injector falls within device claims.
• Whether HSDD method-of-use claims can be carved out.
• Whether claims are obvious in light of prior melanocortin agonist research.
• Whether written-description and enablement requirements are satisfied.

A settlement could delay generic entry beyond the earliest patent expiry while allowing a licensed launch date. Such agreements would require antitrust scrutiny under the FTC’s pharmaceutical-settlement framework.

What are the geographic coverage and manufacturing barriers?

Vyleesi’s commercial presence is primarily U.S.-focused. International rights and approvals are less visible than the U.S. franchise, and the product does not have the global revenue base of major endocrine or women’s-health brands.

Manufacturing barriers include peptide synthesis, sterile fill-finish operations, device assembly and combination-product quality systems. These are meaningful but manageable for established contract manufacturers and generic companies. The autoinjector can create supply risk if only a small number of qualified component suppliers exist.

Key Takeaways

• Vyleesi is an FDA-approved on-demand bremelanotide autoinjector for premenopausal women with acquired, generalized HSDD.
• The product launched in 2019 but has remained a niche commercial asset.
• Commercial ownership moved from AMAG through Covis to Cosette Pharmaceuticals.
• Current detailed revenue, prescription and profitability data are not publicly disclosed because Cosette is privately held.
• Vyleesi competes primarily with Addyi and faces access, diagnosis, tolerability and administration barriers.
• Biosimilar risk is not relevant; generic and 505(b)(2) competition is the applicable threat.
• Patent protection is distributed across formulation, delivery-device, method-of-use and manufacturing claims.
• No publicly established Paragraph IV challenge or major settlement had defined the market through the latest broadly available record.
• The commercial value of the patent estate is constrained by the small addressable population and limited prescription volume.
• Generic entry is more likely to depend on formulation and device design-around economics than on a conventional high-value small-molecule patent battle.

FAQs

Is Vyleesi covered by Medicare?

Coverage varies by plan and indication. Commercial coverage, prior authorization and specialty-pharmacy requirements generally have a greater effect on access than Medicare coverage because the labeled population is premenopausal women.

Can Vyleesi be used after menopause?

Vyleesi’s FDA label is limited to premenopausal women. Use outside the approved population would be off-label and would not carry the same regulatory or reimbursement position.

Is bremelanotide available as a generic injection?

No widely marketed generic bremelanotide injection had been established through the latest broadly available information.

Does Vyleesi require a prescription?

Yes. Vyleesi is a prescription drug supplied through a prefilled autoinjector.

What is the main commercial risk to Vyleesi?

The principal risk is limited repeat use within a narrow, difficult-to-diagnose population. A generic challenge is a secondary risk unless prescription volume and reimbursement improve enough to justify litigation and launch investment.

References

1. U.S. Food and Drug Administration. (2019). FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hypoactive-sexual-desire-disorder-premenopausal-women

2. U.S. Food and Drug Administration. (2023). Vyleesi (bremelanotide) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/

3. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

4. AMAG Pharmaceuticals, Inc. (2020). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.

5. Cosette Pharmaceuticals. (2022). Corporate information and Vyleesi commercialization materials. Cosette Pharmaceuticals.