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
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

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

Constraining patent/regulatory exclusivity:

9,352,013

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.

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

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)

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
European Patent Office	1789069
World Intellectual Property Organization (WIPO)	2014071339
Canada	2890081
Hong Kong	1047881
World Intellectual Property Organization (WIPO)	2006014559

Vyleesi (Bremelanotide) Autoinjector: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is Vyleesi and where does the autoinjector sit in the drug’s profile?

Vyleesi is bremelanotide (melanocortin receptor agonist) for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). In the U.S., the product is marketed in an autoinjector format (the “Vyleesi autoinjector”), with dosing tied to on-demand administration.

Core market implication: Vyleesi’s commercial trajectory is shaped by (1) limited, label-specific patient population, (2) persistent payer scrutiny tied to utilization patterns typical of on-demand sexual health therapies, and (3) competitive pressure in women’s sexual health from branded and off-label options.

What market dynamics drive demand for the Vyleesi autoinjector?

Key demand drivers and constraints are predictable for an on-demand, specialist-indication asset:

1. Narrow label limits addressable volume

   • The indication is confined to premenopausal women with acquired, generalized HSDD. That confines total eligible prevalence and reduces commercial scalability versus broader chronic or multi-diagnosis sexual medicine assets.

2. On-demand usage creates utilization and forecasting volatility

   • Unlike daily therapies, on-demand dosing produces “lumpy” prescribing and reimbursement behavior. This raises:
     • inventory risk for wholesalers,
     • forecasting error for manufacturers,
     • and tighter payer controls tied to cost-effectiveness per treated episode.

3. Reimbursement friction for sexual-health brands

   • Sexual health is a category where payers frequently apply:
     • prior authorization,
     • step edits or coverage limitations,
     • and utilization management that can suppress real-world persistence.

4. Safety/tolerability and tolerability-driven discontinuation

   • Bremelanotide is associated with known class and product-specific adverse effects (notably blood pressure effects and nausea signals that can affect repeat use). In practice this can compress dose adoption and reduce conversion from initial prescriptions to sustained use.

5. Competitive alternatives reshape prescribing behavior

   • The category mixes:
     • branded therapies with different mechanisms,
     • and off-label prescribing in certain settings.
   • That competition tends to push clinicians toward agents with simpler dosing and fewer adverse-effect management burdens.

How does Vyleesi’s autoinjector format influence commercialization economics?

The autoinjector is a usability and patient-experience lever. In market terms it affects:

• Adherence and patient confidence: Device-based delivery reduces injection complexity versus pen or syringe workflows, which can improve initial acceptance.
• Training and real-world administration: Autoinjectors shift some friction from patient handling to prescriber and pharmacy education.
• Payer and formulary discussions: Device-enabled products still face payer pushback based on overall cost per response, but patient usability can improve the “meets expectations” share of starts versus more complex administration formats.

Financial implication: Device format can protect adoption at the margin, but it does not override label limits, payer management, or safety-driven discontinuation.

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What does the financial trajectory look like, and what patterns matter to investors?

A drug’s financial trajectory for a niche, on-demand indication typically shows one or more of these patterns:

• slower ramp post-launch,
• plateau under payer constraints,
• and periodic step-ups only when coverage broadens or competitive pressures change.

Actionable investment lens: For Vyleesi, the autoinjector does not create a new growth engine strong enough to offset:

• constrained eligible population,
• payer utilization management,
• and competition in women’s sexual health.

Trajectory summary for Vyleesi (market-facing view)

The commercial profile has generally followed a brand trajectory that did not transition into high-volume scale, consistent with:

• limited indication scope,
• reliance on on-demand patterns that cap repeat demand,
• and ongoing reimbursement friction.

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What financial KPIs are most predictive for Vyleesi’s future performance?

Investors and commercial leaders typically track these KPIs because they connect demand to revenue conversion in on-demand specialty categories:

KPI	Why it matters for Vyleesi
New-to-brand starts	Measures label conversion and prescriber willingness to adopt
Persistence and re-fill behavior	Captures tolerability and real-world continued use
Share of eligible prescriptions	Shows how payer rules and alternative therapies affect utilization
Net price vs list price	Captures rebate intensity and managed entry outcomes
Gross-to-net trend	Captures payer contracting outcomes and channel mix
Inventory turns	On-demand therapies can create stocking volatility

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What are the key “swing factors” for revenue direction?

The next meaningful revenue inflection would come from one of these levers:

1. Coverage expansion

   • Broader formulary access or reduced prior-authorization barriers changes the effective addressable market.

2. Medical education and prescriber behavior

   • Improved conversion from initial prescriptions to repeat dosing can increase revenue without requiring higher list prices.

3. Competitive displacement or differentiation

   • If competitor access narrows or if Vyleesi outcomes data strengthens payer confidence, adoption can rise.

4. Safety/tolerability management improvements

   • Real-world mitigation strategies can reduce drop-off and raise utilization per start.

5. Drug delivery workflow optimization

   • Autoinjector usability improvements and reduced patient training friction can increase “first-use success,” improving retention.

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Where does the autoinjector affect channel strategy and operating performance?

Device packaging and fulfillment typically influence:

• pharmacy ordering behavior (especially under specialty distribution models),
• patient support infrastructure costs (training, initiation programs),
• return rates (less common for single-use devices but still relevant under certain inventory and patient discontinuation patterns),
• and operating leverage (higher fixed commercialization spend with lower total volume increases unit economics sensitivity).

For Vyleesi, that means operational performance tends to improve slowly unless net volume scales, because fixed commercialization costs persist even as volumes remain niche.

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What could change the financial trajectory materially?

A material change would likely require at least one of these shifts:

• label expansion (larger eligible population),
• broad payer alignment (higher share on formulary with fewer prior authorization barriers),
• or competitive landscape changes that reduce substitution.

Absent these, the autoinjector is a “quality and adoption” lever rather than a “volume expansion” lever.

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Key Takeaways

• Vyleesi’s financial trajectory is constrained by a narrow premenopausal acquired generalized HSDD label and on-demand utilization volatility, which caps scale even with autoinjector usability benefits.
• The autoinjector supports adoption through simplified administration, but it does not materially change the core revenue drivers: payer coverage, tolerability-driven persistence, and competitive substitution.
• The most predictive KPIs are starts, persistence, share of eligible prescriptions, net price/gross-to-net, and inventory turns.
• Revenue inflections likely depend on coverage expansion, label growth, or competitive access shifts, not on device format alone.

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FAQs

1) Is Vyleesi primarily a chronic therapy or an on-demand product?

Vyleesi is administered on-demand, so utilization and revenue forecasting follow episode-based prescribing patterns rather than predictable daily dosing.

2) Does the autoinjector materially expand the eligible patient population?

No. The eligible population is defined by the label; the autoinjector primarily affects usability, initiation success, and persistence.

3) What are the biggest financial headwinds for this type of product?

Limited label scope, payer utilization management, and tolerability-related discontinuation that reduces repeat use.

4) What KPIs best predict whether revenue will accelerate or plateau?

New-to-brand starts, persistence/refill behavior, share of eligible prescriptions, gross-to-net, and inventory turns.

5) What would most likely drive a sustained revenue step-up?

Coverage expansion and changes that increase the effective addressable market or reduce substitution to alternative therapies.

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References

[1] FDA. “Vyleesi (bremelanotide) prescribing information.” U.S. Food and Drug Administration.
[2] U.S. Patent and Trademark Office (USPTO). “Bremelanotide patent and related publication records.” United States Patent and Trademark Office.
[3] Centers for Medicare & Medicaid Services (CMS). “National Drug Codes and related reimbursement documentation.” Centers for Medicare & Medicaid Services.
[4] Drugs@FDA. “Vyleesi (bremelanotide).” U.S. Food and Drug Administration.