Estradiol valerate - Generic Drug Details

What are the generic sources for estradiol valerate and what is the scope of freedom to operate?

Estradiol valerate is the generic ingredient in four branded drugs marketed by Endo Operations, Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, Xiromed, and Savage Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for estradiol valerate. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for estradiol valerate

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	11
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	67
Patent Applications:	4,819
Drug Prices:	Drug price trends for estradiol valerate
What excipients (inactive ingredients) are in estradiol valerate?	estradiol valerate excipients list
DailyMed Link:	estradiol valerate at DailyMed

See drug prices for estradiol valerate

Recent Clinical Trials for estradiol valerate

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

Sponsor	Phase
ART Fertility Clinics LLC	Phase 1
El Shatby University Hospital for Obstetrics and Gynecology	Phase 2/Phase 3
University of California, San Diego	Phase 4

See all estradiol valerate clinical trials

Generic filers with tentative approvals for ESTRADIOL VALERATE

Applicant	Application No.	Strength	Dosage Form
		3MG;2MG;3MG	TABLET;ORAL
		1MG;2MG;2MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for estradiol valerate

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for estradiol valerate

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for estradiol valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	216656-001	Apr 28, 2023	AO	RX	No	No
Watson Labs	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	083546-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Am Regent	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	090920-001	Jan 19, 2010	AO	RX	No	No
Hikma	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	203723-003	Apr 21, 2020	AO	RX	No	No
Savage Labs	DITATE-DS	estradiol valerate; testosterone enanthate	INJECTABLE;INJECTION	086423-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Estradiol valerate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estradiol Valerate

Introduction

Estradiol valerate, a synthetic estrogen derivative, has been a cornerstone in the treatment of various hormonal and metabolic disorders for decades. First approved in the United States in 1954, this drug has seen significant growth and expansion in its market dynamics. Here, we delve into the current market situation, financial trajectory, and key factors influencing the estradiol valerate market.

Market Size and Growth

The estradiol valerate market has witnessed a substantial surge in recent years. The market is projected to continue its upward trajectory from 2023 to 2031, driven by increasing demand and expanding applications. The global estradiol valerate market is expected to grow significantly, with market size predictions indicating a robust expansion during the forecast period[1].

Segmentation

The market is segmented based on several key factors:

By Type

• Purity ≥98%: This segment caters to high-purity requirements, often necessary for pharmaceutical applications.
• Purity ≥99%: This segment is even more stringent, meeting the highest standards of purity, which is crucial for certain therapeutic uses[1].

By Application

• Injection Solution: Used for treating conditions such as estrogen deficiency and certain types of cancer.
• Tablet: Oral formulations for managing symptoms like menopause and hormonal imbalances.
• Other: Includes other forms such as gels, patches, and vaginal rings[1].

By Geography

The market is divided into regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth dynamics influenced by local healthcare infrastructure, regulatory environments, and market demand[1].

Drivers of the Market

Several factors are driving the growth of the estradiol valerate market:

Aging Population

An increasing aging population globally is leading to higher incidence rates of menopause and other age-related hormonal imbalances, thereby increasing the demand for estradiol valerate[3].

Regulatory Approvals

Recent approvals in various regions, such as China, have expanded the market reach and acceptance of estradiol valerate. These approvals highlight the drug's compliance with stringent regulatory standards[4].

Increasing Health Consciousness

Growing health awareness and patient education are leading to more individuals seeking hormonal replacement therapies, contributing to market growth[3].

Technological Advancements

Advancements in drug delivery methods, such as personalized hormone therapy and alternative delivery systems, are enhancing the efficacy and convenience of estradiol valerate treatments[3].

Restraints and Challenges

Despite the growth, the market faces several challenges:

Side Effects and Safety Concerns

Estradiol valerate, like other hormonal therapies, can have side effects and safety concerns, which may limit its adoption in some cases. For instance, it can cause liver test abnormalities and may exacerbate liver injury in patients with severe liver disease[4].

Competition from Alternative Therapies

The market is competitive, with other hormonal replacement therapies and alternative treatments available. This competition can impact the market share of estradiol valerate[3].

Competitive Landscape

The competitive landscape of the estradiol valerate market is characterized by the presence of several key players:

Major Players

Companies such as Xianju Pharmaceutical, Junye Pharmaceutical, Grand Xinyi Pharmaceutical, Chenshi Pharmaceutical, and others are prominent in the market. These companies are involved in continuous research and development, strategic market approaches, and geographical expansions[1].

SWOT Analysis

A SWOT analysis of these companies reveals their strengths in product portfolios, financial stability, and market position. However, they also face weaknesses such as intense competition and potential regulatory hurdles. Opportunities include expanding into new markets and developing new delivery methods, while threats include economic fluctuations and changing healthcare policies[1].

Financial Trajectory

The financial trajectory of the estradiol valerate market is promising:

Revenue Projections

The market is expected to grow from a significant base value in 2023 to a higher value by 2031, with a compound annual growth rate (CAGR) that reflects strong market dynamics[1].

Healthcare Expenditures

Increasing healthcare expenditures globally are supporting the growth of the estradiol valerate market. For example, healthcare spending in the United States increased significantly in recent years, indicating a trend that is likely to continue[3].

Regional Analysis

The market performance varies by region:

Asia-Pacific

This region is showing notable growth due to improving healthcare infrastructure, increasing health consciousness, and regulatory approvals. China, in particular, has been a significant market for estradiol valerate following its approval[1][4].

North America and Europe

These regions also contribute substantially to the market due to high healthcare spending and a large aging population. The presence of major pharmaceutical companies in these regions further drives market growth[1].

Market Outlook

The market outlook for estradiol valerate is positive, driven by several factors:

Porter's 5 Forces Framework

An analysis using Porter's 5 Forces Framework reveals a competitive market with moderate bargaining power of suppliers and buyers. The threat of new entrants is relatively low due to regulatory barriers, while the threat of substitutes is moderate due to the presence of other hormonal therapies[1].

Value Chain Evaluation

The value chain evaluation highlights the importance of research and development, manufacturing, and distribution in the market. Companies that excel in these areas are likely to gain a competitive edge[1].

Key Takeaways

• The estradiol valerate market is expected to grow significantly from 2023 to 2031.
• The market is driven by an aging population, regulatory approvals, and increasing health consciousness.
• Key players are focusing on research and development, new delivery methods, and geographical expansions.
• The market faces challenges such as side effects and competition from alternative therapies.
• Healthcare expenditures and regional growth, especially in the Asia-Pacific region, are supporting market expansion.

Frequently Asked Questions (FAQs)

Q: What are the primary applications of estradiol valerate? A: Estradiol valerate is used in the treatment of various conditions including estrogen deficiency symptoms, menopausal symptoms, and certain types of cancer[4].

Q: Which regions are driving the growth of the estradiol valerate market? A: The Asia-Pacific region, particularly China, along with North America and Europe, are driving the market growth due to regulatory approvals, healthcare infrastructure, and increasing health consciousness[1][4].

Q: What are the key drivers of the estradiol valerate market? A: The market is driven by an aging population, regulatory approvals, increasing health consciousness, and technological advancements in drug delivery methods[3].

Q: Who are the major players in the estradiol valerate market? A: Major players include Xianju Pharmaceutical, Junye Pharmaceutical, Grand Xinyi Pharmaceutical, Chenshi Pharmaceutical, and others[1].

Q: What are the potential restraints to the growth of the estradiol valerate market? A: The market faces restraints such as side effects and safety concerns, competition from alternative therapies, and economic fluctuations[3][4].

Cited Sources:

1. Market Research Intellect, "Global Estradiol Valerate Market Size, Scope And Forecast Report", October 2024.
2. Uniform Medical Plan, "Prescription drug preauthorization criteria", December 2024.
3. The Business Research Company, "Drugs For Hormonal Replacement Therapy Market Definition", 2023.
4. Patsnap Synapse, "Estradiol valerate: Detailed Review of its Transformative R&D Success", September 2023.