MUSE Drug Patent Profile

When do Muse patents expire, and what generic alternatives are available?

Muse is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in MUSE is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Muse

A generic version of MUSE was approved as alprostadil by HIKMA on January 20^th, 1998.

Summary for MUSE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,172
Drug Prices:	Drug price information for MUSE
What excipients (inactive ingredients) are in MUSE?	MUSE excipients list
DailyMed Link:	MUSE at DailyMed

See drug prices for MUSE

US Patents and Regulatory Information for MUSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996		DISCN	Yes	No
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996		DISCN	Yes	No
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996		DISCN	Yes	No
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996		DISCN	Yes	No

Expired US Patents for MUSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996

International Patents for MUSE

See the table below for patents covering MUSE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0526566	TRAITEMENT DE DYSFONCTIONNEMENT ERECTILE (TREATMENT OF ERECTILE DYSFUNCTION)
Ireland	81089	Treatment of erectile dysfunction
Ireland	911330
Japan	H05506800

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MUSE

Last updated: July 27, 2025

Introduction

MUSE (Medicated Urethral Slings for Erectile Dysfunction) signifies a novel, minimally invasive treatment option primarily targeting erectile dysfunction (ED). With the increasing prevalence of ED globally, driven by aging populations, lifestyle factors, and comorbid conditions such as diabetes and cardiovascular disease, the pharmaceutical and medical device sectors are witnessing substantial innovation investments in this domain. This article evaluates the current market landscape, growth drivers, competitive positioning, regulatory environment, and the projected financial trajectory for MUSE in the context of the broader ED treatment market.

Market Overview and Demand Drivers

Erectile dysfunction affects an estimated 150 million men worldwide, a number projected to increase to approximately 322 million by 2025, according to the International Journal of Impotence Research [1]. The rising demographic burden alongside increased awareness and growing acceptance of ED treatments catalyze demand.

Traditional pharmacotherapy—mainly phosphodiesterase type 5 inhibitors (PDE5 inhibitors such as sildenafil, tadalafil)—dominates the treatment landscape. However, limitations including contraindications, side effects, and patient reluctance for oral medication sustain the market’s opening for innovative modalities like MUSE, which offers localized therapy with potentially fewer systemic side effects.

Medical device innovations, especially minimally invasive options, tend to capture clinician and patient interest due to improved safety profiles, ease of administration, and compatibility with outpatient settings. MUSE's unique delivery method, involving medicated urethral suppositories, aligns with this demand trend.

Market Dynamics Shaping MUSE’s Trajectory

Competitive Landscape

The ED treatment market is highly competitive, featuring pharmaceutical giants like Pfizer, Eli Lilly, and Bayer, alongside specialized medical device companies. While PDE5 inhibitors command a significant market share, the niche segment of urethral and minimally invasive devices like MUSE offers incremental growth opportunities.

MUSE faces competition primarily from other intracavernosal injection devices, vacuum erection devices, and emerging oral or implantable solutions. Its differentiation hinges on its minimally invasive approach, rapid onset of action, and reduced side-effect profile.

Regulatory and Reimbursement Environment

Regulatory approval pathways for ED devices vary globally. In the U.S., the FDA’s Office of Entertainment Devices and Radiological Health oversees such treatments. MUSE benefits from existing approvals (e.g., FDA clearance for Alprostadil suppositories), streamlining its market entry. Reimbursement policies influence adoption; companies often negotiate coverage with Medicare and private insurers based on clinical efficacy, safety, and cost-effectiveness.

Technological Innovation and R&D

Ongoing R&D efforts aim to enhance the efficacy, ease of use, and patient comfort associated with MUSE. Advances including improved delivery mechanisms, combination therapies, and integration with digital health platforms could bolster its appeal.

Market Penetration and Adoption Barriers

Despite clinical advantages, adoption may face barriers such as clinician familiarity, patient acceptance of urethral delivery, and the cost differential compared to oral medications. Awareness campaigns and training programs are critical to accelerating uptake.

Financial Trajectory and Investment Outlook

Revenue Projections

The ED treatment market was valued at USD 4.9 billion in 2021 and is projected to grow at a CAGR of 6.8% through 2030 [2]. While PDE5 inhibitors dominate, niche therapies like MUSE are expected to contribute incremental revenue streams, especially in specific segments—e.g., patients contraindicated for oral drugs, or those seeking rapid onset.

Market penetration estimates suggest MUSE could capture 2-5% of the urethral ED device segment within five years post-launch, translating to revenues in the hundreds of millions. Early adopters and urology clinics in North America and Europe will be pivotal in volume scaling.

Cost Structure and Profitability

Manufacturing costs for MUSE are relatively low, owing to the low complexity of suppository production. Margins depend on pricing strategies, reimbursement levels, and market penetration. Pricing typically ranges between USD 25-50 per dose, with potential for bundling and subscription models.

Investment and Funding Trends

Venture capital and corporate investments have prioritized minimally invasive ED devices given their growth potential and high margins. Notable players include specialty device firms and biotech startups focusing on niche therapeutic areas. Funding rounds for innovations similar to MUSE have seen CAGR of 12% over the past five years, indicating strong investor confidence in the sector.

Regulatory Milestones and Timeframe

Achieving full regulatory approval for extended indications and international markets can take 2-3 years. The timing of such milestones influences revenue forecasts, with early market entry translating to higher cumulative sales.

Market Challenges and Opportunities

Challenges

• Patient Acceptance: Cultural and psychological barriers may slow adoption, especially for urethral delivery.
• Competitive Substitutes: The dominance of oral PDE5 inhibitors constrains market share growth.
• Pricing Pressures: Insurance and reimbursement constraints could suppress pricing and margins.
• Regulatory Delays: Variability in approval processes across countries can impede international expansion.

Opportunities

• Specialized Patient Segments: Targeting populations contraindicated for oral medications, such as post-prostatectomy patients.
• Combination Therapies: Integrating with other ED treatments for synergistic effects.
• Digital Health Integration: Using mobile apps and telemedicine to improve patient engagement.
• Geographical Expansion: Capturing emerging markets where ED awareness and treatment are increasing.

Strategic Recommendations for Stakeholders

• For Developers: Focus on clinical trials that demonstrate comparative advantages over existing treatments to bolster reimbursement and clinician adoption.
• For Investors: Monitor regulatory milestones closely; early approval in key markets significantly enhances valuation.
• For Clinicians: Educate patients on minimally invasive options to diversify treatment paradigms.
• For Policymakers: Support pathways to facilitate access to innovative ED treatments, considering their impact on quality of life.

Conclusion

MUSE's market potential hinges on its ability to carve a niche in an established but evolving ED treatment landscape. While facing stiff competition from dominant oral therapies, its unique minimally invasive profile offers substantial growth opportunities, particularly among specific patient groups. Financial projections suggest a promising trajectory, contingent upon regulatory success, clinician acceptance, and strategic market expansion.

Diligent innovation, integrated marketing, and favorable reimbursement policies will be key drivers shaping MUSE’s financial trajectory over the next decade.

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Key Takeaways

• The global ED market is expanding, with a significant segment for minimally invasive therapies like MUSE.
• Market growth is driven by demographic shifts, rising awareness, and demand for localized treatment options.
• Competitive pressures from PDE5 inhibitors necessitate clinical evidence to demonstrate MUSE's advantages.
• Regulatory approvals and reimbursement strategies are critical to commercial success.
• Financial prospects are favorable, with expected revenues reaching hundreds of millions post-market penetration.

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FAQs

1. How does MUSE differentiate from other ED treatments?
MUSE offers a minimally invasive urethral suppository delivery of medication, providing rapid onset with fewer systemic side effects, appealing to patients contraindicated for oral ED drugs or seeking alternative options.

2. What are the main barriers to MUSE’s market adoption?
Patient acceptance of urethral delivery, clinician familiarity, pricing pressures, and competition from established oral medications are primary hurdles.

3. What is the expected timeline for MUSE to achieve significant market penetration?
Typically, 3-5 years post-launch, assuming regulatory approvals, reimbursement coverage, and clinician adoption progress smoothly.

4. In what regions is MUSE most likely to succeed initially?
North America and Europe represent primary markets due to high prevalence, mature healthcare infrastructure, and favorable regulatory environments.

5. What are the growth prospects for MUSE within the broader ED market?
While not replacing first-line oral therapies, MUSE will likely grow as a complementary niche, particularly among patient populations with unmet needs, contributing incremental revenues and expanding treatment options.