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Last Updated: December 22, 2024

ESTRAMUSTINE PHOSPHATE SODIUM - Generic Drug Details


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What are the generic sources for estramustine phosphate sodium and what is the scope of freedom to operate?

Estramustine phosphate sodium is the generic ingredient in one branded drug marketed by Pharmacia And Upjohn and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for estramustine phosphate sodium.

Summary for ESTRAMUSTINE PHOSPHATE SODIUM
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 55
Clinical Trials: 31
Patent Applications: 6,655
What excipients (inactive ingredients) are in ESTRAMUSTINE PHOSPHATE SODIUM?ESTRAMUSTINE PHOSPHATE SODIUM excipients list
DailyMed Link:ESTRAMUSTINE PHOSPHATE SODIUM at DailyMed
Recent Clinical Trials for ESTRAMUSTINE PHOSPHATE SODIUM

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

SponsorPhase
University of Massachusetts, WorcesterPhase 2
National Institutes of Health Clinical Center (CC)Phase 2
Dana-Farber Cancer InstitutePhase 2

See all ESTRAMUSTINE PHOSPHATE SODIUM clinical trials

Medical Subject Heading (MeSH) Categories for ESTRAMUSTINE PHOSPHATE SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for ESTRAMUSTINE PHOSPHATE SODIUM

US Patents and Regulatory Information for ESTRAMUSTINE PHOSPHATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn EMCYT estramustine phosphate sodium CAPSULE;ORAL 018045-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ESTRAMUSTINE PHOSPHATE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estramustine Phosphate Sodium

Introduction

Estramustine phosphate sodium, a unique antitumor agent, has been a significant player in the treatment of prostate cancer, particularly in cases of hormone-refractory disease. This article delves into the market dynamics and financial trajectory of estramustine phosphate sodium, exploring its efficacy, market trends, and financial assistance programs.

Efficacy and Clinical Use

Estramustine phosphate sodium is selectively taken up by prostate cells, exerting antineoplastic effects by interfering with microtubule dynamics and reducing plasma levels of testosterone. In clinical studies, it has shown promising results, with objective response rates ranging from 19 to 69% in patients with hormone-refractory prostate cancer[1].

Combination Therapy

Combining estramustine phosphate with other chemotherapeutic agents like vinblastine, etoposide, or paclitaxel has been shown to improve objective response rates, although no significant survival benefit has been demonstrated over single-agent treatment[1].

Comparative Studies

Estramustine phosphate produces similar objective response rates to conventional antineoplastic agents in patients with hormone-refractory prostate cancer. In previously untreated patients with advanced metastatic hormone-responsive prostate cancer, it achieves objective responses in approximately 80% of patients, making it as effective as estrogen or flutamide therapy[1].

Market Insights

Global Market Report

The global estramustine phosphate market is analyzed in detail through segments and sub-segments, providing crucial market insights. The market report highlights growth drivers, challenges, and opportunities, offering a comprehensive overview of the market's current and future trends[4].

Market Size and Growth

While specific figures for the current market size of estramustine phosphate are not provided in the sources, the demand for this drug is sustained by its efficacy in treating prostate cancer, particularly in advanced stages. The market is expected to grow as the incidence of prostate cancer increases and as more patients seek effective treatments.

Financial Trajectory

Cost and Affordability

The cost of treating prostate cancer with estramustine phosphate sodium can be significant, but various patient assistance programs help make the drug more affordable. For instance, programs offered by pharmaceutical companies and patient advocacy groups provide financial assistance to eligible patients[5].

Patient Assistance Programs

Companies like Pfizer and AbbVie offer patient assistance programs that include financial aid, dedicated support staff, and other resources. For example, the Pfizer Patient Assistance Program helps eligible patients access medications, including those for oncology, by providing free medicine to those at or below certain percentages of the Federal Poverty Level[2][5].

Financial Assistance and Reimbursement

Pfizer Patient Assistance Program

Pfizer's program offers comprehensive reimbursement and patient support services. Patients must meet specific eligibility criteria, such as being at or below 300% or 500% of the Federal Poverty Level, adjusted for family size, to qualify for free medicine[2].

AbbVie Patient Assistance

AbbVie also provides patient assistance for its products, including those used in oncology. Their program includes financial aid and support resources to help patients access necessary medications[5].

Adverse Effects and Management

Common Adverse Effects

Estramustine phosphate sodium is associated with adverse effects such as nausea and vomiting, which are usually mild to moderate but can occasionally necessitate treatment withdrawal. Cardiovascular complications are less frequent but more serious and can be mitigated through careful patient selection and prophylactic measures[1].

Impact on Patient Quality of Life

Subjective Status and Pain Management

Beyond its objective response rates, estramustine phosphate sodium improves the subjective status of many patients. It has been shown to reduce the intensity of pain and improve the performance status of patients, significantly enhancing their quality of life[1].

Regulatory and Market Trends

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of estramustine phosphate sodium. Approvals and guidelines set by regulatory bodies influence the drug's availability and usage. Any changes in regulations can impact the market trajectory of the drug.

Market Competition

The market for prostate cancer treatments is competitive, with various drugs and therapies available. Estramustine phosphate sodium competes with other antineoplastic agents and hormonal therapies, and its market share is influenced by its efficacy, safety profile, and cost-effectiveness.

Future Outlook

Emerging Treatments and Research

The future outlook for estramustine phosphate sodium is tied to ongoing research and the emergence of new treatments for prostate cancer. As new compounds and therapies are developed, the market dynamics may shift, but the established efficacy of estramustine phosphate sodium is likely to maintain its relevance.

Market Expansion

The global estramustine phosphate market is expected to expand as the incidence of prostate cancer increases and more patients seek effective treatments. Market expansion will also be driven by the availability of patient assistance programs and the drug's proven efficacy.

Key Takeaways

  • Efficacy: Estramustine phosphate sodium is effective in treating hormone-refractory prostate cancer with significant objective response rates.
  • Market Insights: The global market for estramustine phosphate is analyzed through segments and sub-segments, highlighting growth drivers and challenges.
  • Financial Assistance: Various patient assistance programs make the drug more affordable for eligible patients.
  • Adverse Effects: The drug is associated with nausea, vomiting, and less frequently, cardiovascular complications.
  • Quality of Life: It improves the subjective status of patients, reduces pain, and enhances performance status.
  • Regulatory Environment: Regulatory approvals and guidelines influence the drug's market dynamics.
  • Future Outlook: The market is expected to expand with ongoing research and the emergence of new treatments.

FAQs

What is estramustine phosphate sodium used for?

Estramustine phosphate sodium is used primarily for the treatment of hormone-refractory prostate cancer. It selectively targets prostate cells and exerts antineoplastic effects.

How effective is estramustine phosphate sodium in treating prostate cancer?

Estramustine phosphate sodium has shown objective response rates ranging from 19 to 69% in patients with hormone-refractory prostate cancer. In previously untreated patients with advanced metastatic hormone-responsive prostate cancer, it achieves objective responses in approximately 80% of patients.

What are the common adverse effects of estramustine phosphate sodium?

The most frequently observed adverse effects are nausea and vomiting, which are usually mild to moderate. Cardiovascular complications are less frequent but more serious.

Are there any patient assistance programs available for estramustine phosphate sodium?

Yes, various patient assistance programs, such as those offered by Pfizer and AbbVie, provide financial assistance and support resources to eligible patients.

How does estramustine phosphate sodium impact patient quality of life?

Estramustine phosphate sodium improves the subjective status of many patients, reduces the intensity of pain, and enhances their performance status, significantly improving their quality of life.

Sources

  1. Estramustine phosphate sodium. A review of its pharmacodynamic ... - PubMed
  2. Treatment-Specific Patient Support Hubs - Pfizer RxPathways
  3. DiscoverBMB Seattle | March 25–28, 2023 - Journal of Biological Chemistry
  4. Estramustine Phosphate Market Report 2024 (Global Edition) - Cognitive Market Research
  5. Patient Assistance & Reimbursement Guide Companies A-Z - ACCC Cancer.org

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