EULEXIN Drug Patent Profile

When do Eulexin patents expire, and when can generic versions of Eulexin launch?

Eulexin is a drug marketed by Schering and is included in one NDA.

The generic ingredient in EULEXIN is flutamide. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flutamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eulexin

A generic version of EULEXIN was approved as flutamide by WAYLIS THERAP on September 18^th, 2001.

Summary for EULEXIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	16
Patent Applications:	4,370
DailyMed Link:	EULEXIN at DailyMed

Recent Clinical Trials for EULEXIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fudan University	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1
University of Virginia	Phase 1

See all EULEXIN clinical trials

US Patents and Regulatory Information for EULEXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989		DISCN	Yes	No

Expired US Patents for EULEXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	4,329,364
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	4,472,382
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	5,712,251

International Patents for EULEXIN

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

Country	Patent Number	Title	Estimated Expiration
France	2465486
Japan	S6237018
Australia	542765
South Africa	8005791
Japan	S61118324	NOVEL THERAPEUTICAL COMPOSITION USING LH_RH OR AGONIST
Australia	572938

EULEXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EULEXIN

Introduction

EULEXIN, also known as flutamide, is a non-steroidal antiandrogen used primarily in the treatment of prostate cancer. Understanding the market dynamics and financial trajectory of EULEXIN involves analyzing various factors, including market trends, competitive landscape, regulatory environment, and patient demographics.

Market Trends in Androgen Deprivation Therapy

The androgen deprivation therapy (ADT) market, which includes EULEXIN, is experiencing significant growth driven by several key factors.

Rising Incidence of Prostate Cancer

The increasing global incidence of prostate cancer is a major driver for the ADT market. In the United States alone, the American Cancer Society estimates that approximately 299,010 new cases of prostate cancer will be reported in 2024, making it the most common cancer among American men[1].

Growing Geriatric Population

The geriatric population is growing, and this demographic is more prone to prostate cancer. This demographic shift is expected to increase the demand for ADT treatments, including EULEXIN.

Product Approvals and R&D Activities

Recent product approvals and ongoing research and development activities are boosting the market. For instance, the Phase 1/2 trial of masofaniten, a new androgen receptor inhibitor, in collaboration with major pharmaceutical companies, indicates a vibrant R&D landscape[1].

Competitive Landscape

The competitive landscape for antiandrogen drugs like EULEXIN is highly active.

Key Players

Several pharmaceutical companies, including Bayer AG, Pfizer Inc., Suzhou Kintor Pharmaceuticals, Inc., and Johnson & Johnson, are actively involved in developing drugs targeting the androgen receptor. This competition drives innovation and affects market dynamics[4].

Drug Types and Indications

EULEXIN is part of a broader class of antiandrogen drugs that include flutamide, bicalutamide, nilutamide, enzalutamide, apalutamide, and darolutamide. These drugs are used for various indications, including prostate cancer, hypogonadism, breast cancer, and others[1][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of EULEXIN.

FDA Approvals and Scrutiny

The FDA's approval process and increased scrutiny of generic drug applications can impact the market. For example, the FDA's policy changes in the 1990s affected the cost and timing of generic drug approvals, which can influence the financial trajectory of branded drugs like EULEXIN[3].

Generic Competition

Generic versions of EULEXIN can significantly impact its market share and pricing. Generic drug prices tend to fall as the number of competitors increases, with prices approaching long-run marginal costs when there are eight or more competitors[3].

Financial Trajectory

The financial trajectory of EULEXIN is influenced by several factors:

Revenue and Market Share

The revenue generated by EULEXIN is expected to be impacted by the growing demand for ADT treatments. However, the entry of generic competitors and new branded drugs can erode its market share over time[1][3].

Pricing Dynamics

The pricing of EULEXIN is subject to competitive pressures. As more generic versions enter the market, prices are likely to decline. Initially, generic prices can be 35% to 50% above long-run marginal costs, but they decrease as more competitors enter the market[3].

Patient Access Programs

Patient access programs, such as Schering's COMMITMENT TO CARE™, can help patients find financial reimbursement for EULEXIN, which can influence its financial performance by maintaining patient adherence and loyalty[5].

Regional Market Performance

North America

North America, particularly the United States, is expected to hold a significant share of the ADT market. The high incidence of prostate cancer and the presence of major pharmaceutical companies drive this market[1].

Global Expansion

Other regions, such as China and the European Union, are also seeing significant growth in the development and use of antiandrogen drugs. China, in particular, is making rapid progress in drug development for androgen receptor targets[4].

Research and Development

Clinical Trials and Drug Development

The ongoing R&D activities, including clinical trials and the development of new drug types like PROTACs, are crucial for the long-term financial health of EULEXIN and similar drugs. As of 2023, there are over 2,040 clinical trials related to androgen receptor drugs, indicating a robust pipeline[4].

Collaborative Efforts

Collaborations between pharmaceutical companies, such as the Phase 1/2 trial of masofaniten with enzalutamide, highlight the collaborative efforts in advancing ADT treatments. These collaborations can lead to innovative therapies and potentially new revenue streams[1].

Patient Demographics and Needs

Geriatric Population

The growing geriatric population is a key demographic for EULEXIN. This age group is more susceptible to prostate cancer, and their healthcare needs drive the demand for effective ADT treatments.

Patient Compliance and Adherence

Patient compliance and adherence to treatment regimens are critical for the financial success of EULEXIN. Programs that facilitate financial reimbursement and patient support can enhance adherence and overall market performance[5].

Key Takeaways

• The ADT market, including EULEXIN, is driven by rising prostate cancer incidence, a growing geriatric population, and robust R&D activities.
• The competitive landscape is highly active with multiple pharmaceutical companies involved.
• Regulatory changes and generic competition significantly impact the financial trajectory of EULEXIN.
• Regional markets, especially North America, are crucial for the drug's revenue.
• Ongoing R&D and collaborative efforts are essential for long-term market success.

FAQs

What are the primary drivers of the androgen deprivation therapy market?

The primary drivers include the rising incidence of prostate cancer, a growing geriatric population, product approvals, and increasing R&D activities.

How does the entry of generic competitors affect EULEXIN's market share?

The entry of generic competitors can significantly erode EULEXIN's market share and reduce its pricing power as generic prices decline with the number of competitors.

What role do patient access programs play in EULEXIN's financial performance?

Patient access programs help patients find financial reimbursement, which can maintain patient adherence and loyalty, thereby influencing the drug's financial performance positively.

Which regions are expected to see significant growth in the ADT market?

North America, particularly the United States, and regions like China and the European Union are expected to see significant growth.

How do collaborative R&D efforts impact the market for EULEXIN?

Collaborative R&D efforts can lead to innovative therapies, potentially new revenue streams, and enhanced market competitiveness.

Sources

1. Mordor Intelligence: Androgen Deprivation Therapy Market Trends - Mordor Intelligence
2. IROC Houston: RTOG 0521 RADIATION THERAPY ONCOLOGY
3. Federal Trade Commission: Generic Drug Industry Dynamics
4. Patsnap Synapse: An In-depth Analysis of Flutamide's R&D Progress and Mechanism ...
5. FDA: NDA 18-554/S-022 - accessdata.fda.gov