MUSE Drug Patent Profile

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

Muse is a drug marketed by Mylan Speciality Lp 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:	77
Patent Applications:	4,231
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
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996		DISCN	Yes	No
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996		DISCN	Yes	No
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996		DISCN	Yes	No
Mylan Speciality Lp	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
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996

International Patents for MUSE

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

Country	Patent Number	Title	Estimated Expiration
Finland	104946
European Patent Office	0432199	COMPOSITION FOR THE TREATMENT OF ERECTILE DYSFUNCTION
Australia	638414
Ireland	62587	Composition for the treatment of erectile dysfunction
Spain	2124225
Australia	7856391
South Korea	0169950

MUSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MUSE

Introduction to MUSE

MUSE, or the Medicated Urethral System for Erection, is a single-dose, medicated transurethral system designed to treat erectile dysfunction (ED). It delivers alprostadil, a vasodilator, directly into the male urethra to facilitate erections[5].

Market Overview

Demand and Growth

The erectile dysfunction drugs market is experiencing significant growth, driven by increasing product approvals and launches. MUSE, as a part of this market, is expected to register rapid revenue growth during the forecast period. The segment is bolstered by the need for effective and less intrusive treatments for ED[4].

Competitive Landscape

MUSE operates in a competitive market with various treatment options available, including oral medications like Viagra and newer topical gel therapies such as MED3000 (Eroxon). However, MUSE remains a successful alternative due to its unique delivery system and effectiveness in patients who may not respond well to other treatments[4].

Patient Preferences and Barriers

Patient reluctance to seek treatment and the availability of counterfeit ED drugs are significant barriers to market growth. However, MUSE's unique delivery method and the lack of need for oral medication make it an attractive option for some patients. The comfort and ease of use of MUSE, particularly compared to intrapenile injections, also contribute to its market appeal[4].

Financial Trajectory

Revenue Projections

The MUSE segment is anticipated to experience rapid revenue growth due to its effectiveness and the growing demand for ED treatments. The market expansion is driven by the increasing acceptance and use of MUSE as a viable treatment option for erectile dysfunction[4].

Pricing and Cost Considerations

The cost of MUSE can be a factor in its adoption, but its unique benefits and the convenience of its delivery system often justify the expense for patients seeking effective ED treatment. Insurance coverage and patient access programs can also influence the financial trajectory by making the treatment more accessible to a broader patient base[4].

Strategic Initiatives and Partnerships

Collaborations and Agreements

Companies in the ED treatment market, including those offering MUSE, often engage in strategic partnerships and agreements to enhance market access and revenue growth. For example, collaborations between pharmaceutical companies and digital health platforms can facilitate the distribution and prescription of MUSE, driving its financial performance[4].

Clinical Efficacy and Regulatory Approval

Clinical Trials and Outcomes

MUSE has undergone extensive clinical trials, demonstrating its efficacy in treating erectile dysfunction. Studies have shown that patients using MUSE had significantly higher success rates in achieving erections sufficient for sexual intercourse compared to those using a placebo. These positive outcomes have contributed to its regulatory approval and market acceptance[5].

Regulatory Environment

The FDA approval of MUSE has been a critical factor in its market success. The drug's indication for the treatment of erectile dysfunction, as established through clinical trials, has helped in securing a strong market position. Regulatory approvals and compliance are essential for maintaining and expanding the financial trajectory of MUSE[5].

Market Access and Patient Access Strategies

Distribution and Prescription

MUSE is distributed through various channels, including pharmacies and healthcare providers. Strategic partnerships, such as those between pharmaceutical companies and digital health platforms, can enhance its availability and prescription rates. This widespread distribution contributes to its financial growth and market penetration[4].

Patient Access Programs

Patient access programs, including insurance coverage and financial assistance initiatives, play a crucial role in making MUSE more accessible to patients. These programs help in reducing the financial barriers to treatment, thereby increasing the adoption rate and driving revenue growth[4].

Future Outlook

Innovations and Technological Advancements

The future of MUSE and similar ED treatments is likely to be influenced by innovations in drug delivery techniques and novel molecule combinations. As the market continues to evolve, companies are expected to invest in research and development to improve existing treatments and develop new ones, potentially further enhancing the financial trajectory of MUSE[4].

Market Expansion

The ED drugs market, including MUSE, is expected to expand through strategic initiatives such as research collaborations, partnerships, and agreements. Companies are likely to continue focusing on improving patient access, enhancing treatment efficacy, and reducing costs, all of which will contribute to the ongoing financial growth of MUSE[4].

Key Takeaways

• Market Growth: MUSE is expected to register rapid revenue growth due to its effectiveness and the growing demand for ED treatments.
• Competitive Advantage: MUSE's unique delivery system and effectiveness make it a competitive option in the ED treatment market.
• Regulatory Approval: FDA approval has been crucial for MUSE's market success.
• Patient Access: Patient access programs and strategic partnerships are key to increasing the adoption rate of MUSE.
• Future Outlook: Innovations in drug delivery and novel molecule combinations are expected to further enhance the financial trajectory of MUSE.

FAQs

What is MUSE used for?

MUSE is used for the treatment of erectile dysfunction. It delivers alprostadil, a vasodilator, directly into the male urethra to facilitate erections[5].

How does MUSE work?

MUSE works by delivering alprostadil through a medicated pellet inserted into the urethra. The alprostadil is absorbed by the urethral mucosa and transferred to the corpora cavernosa, causing an erection[5].

What are the benefits of using MUSE?

MUSE offers a less intrusive alternative to other ED treatments like intrapenile injections. It has been shown to improve success rates for sexual intercourse and enhance the quality of life for patients and their partners[5].

Are there any contraindications for MUSE?

Yes, MUSE is contraindicated in men with certain conditions, such as bleeding disorders or those who have experienced a recent myocardial infarction[5].

How is MUSE administered?

MUSE is administered by inserting the applicator stem into the urethra after urination and depressing the applicator button to release the medicated pellet[5].

Sources

1. Accessdata.fda.gov - MUSE® (alprostadil) urethral suppository - DESCRIPTION
2. Emergen Research - Erectile Dysfunction Drugs Market Market Size
3. Claritasrx.com - The AI Revolution in Drug Development and Patient Recruitment
4. Emergen Research - Erectile Dysfunction Drugs Market Market Size
5. Accessdata.fda.gov - MUSE® (alprostadil) urethral suppository - DESCRIPTION