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Last Updated: December 22, 2024

Estradiol cypionate; medroxyprogesterone acetate - Generic Drug Details


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What are the generic sources for estradiol cypionate; medroxyprogesterone acetate and what is the scope of freedom to operate?

Estradiol cypionate; medroxyprogesterone acetate 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.

Summary for estradiol cypionate; medroxyprogesterone acetate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 2
DailyMed Link:estradiol cypionate; medroxyprogesterone acetate at DailyMed
Recent Clinical Trials for estradiol cypionate; medroxyprogesterone acetate

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

SponsorPhase
Galeno Desenvolvimento de Pesquisas ClínicasPhase 1
Biolab Sanus FarmaceuticaPhase 1
Sun Pharmaceutical Industries LimitedPhase 1/Phase 2

See all estradiol cypionate; medroxyprogesterone acetate clinical trials

US Patents and Regulatory Information for estradiol cypionate; medroxyprogesterone acetate

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 LUNELLE estradiol cypionate; medroxyprogesterone acetate INJECTABLE;INTRAMUSCULAR 020874-001 Oct 5, 2000 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

Estradiol cypionate; medroxyprogesterone acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Injectable Contraceptives: Estradiol Cypionate and Medroxyprogesterone Acetate

Introduction

Injectable contraceptives, including estradiol cypionate and medroxyprogesterone acetate, are highly effective and popular methods of birth control globally. This article delves into the market dynamics, financial trajectory, and key aspects of these injectable contraceptives.

Market Size and Growth

The injectable contraceptives market is experiencing significant growth. As of 2023, the market size was valued at USD 352.43 million and is projected to reach USD 460.66 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 3.9% during the forecast period[1][4].

Types of Injectable Contraceptives

The market is segmented into two main types: progestogen-only injectable contraceptives and combined injectable contraceptives.

Progestogen-Only Injectables

This segment dominates the market and includes products like depot medroxyprogesterone acetate (DMPA) and norethisterone enanthate. These contraceptives are administered intramuscularly or subcutaneously and are known for their effectiveness and reliability, with DMPA having a failure rate of about 4% per year[1][4].

Combined Injectables

Combined injectable contraceptives, such as those containing estradiol cypionate and medroxyprogesterone acetate, are less common but still significant. An example is Lunelle, a microcrystalline aqueous suspension that combines estradiol cypionate with medroxyprogesterone acetate, although this product is discontinued in the United States[2][5].

Key Players

The market is driven by several key players, including Pfizer Inc., Merck & Co., Inc., Amphastar Pharmaceutical Inc., Zhejiang Xianju Pharmaceutical Co., Ltd., Eugia Pharma, Mylan Labs Ltd., Bayer Plc, and Teva Pharmaceuticals[1].

End-User Segments

The end-user segments for injectable contraceptives include hospitals, gynecology clinics, retail pharmacies, online pharmacies, and public health programs. Hospitals dominate the market, holding the largest revenue share, while retail pharmacies are also significant due to their accessibility[4].

Regional Dominance

North America is expected to dominate the injectable contraceptives market during the forecast period, driven by high awareness and accessibility of these products[1].

Clinical and Pharmacological Aspects

Estradiol Cypionate

Estradiol cypionate is an estrogen ester and a long-lasting prodrug of estradiol. It is administered via intramuscular or subcutaneous injection and has a duration of action ranging from 11 to 24 days, depending on the formulation. It is used in combination with medroxyprogesterone acetate in some products but is also available as a standalone estrogen therapy[2][3].

Medroxyprogesterone Acetate (DMPA)

DMPA is a progestogen-only injectable contraceptive that is highly effective, with a failure rate of about 4% per year. It is administered every three months and is widely registered and available in over 100 countries[1].

Research and Development

Research in the area of injectable contraceptives is focused on improving access, reducing side effects, and enhancing drug delivery systems. For DMPA, studies are aimed at lowering the dose while maintaining efficacy and exploring the association between DMPA and HIV, as well as its effects when administered during medication abortion[4].

Side Effects and Safety Profile

Both estradiol cypionate and medroxyprogesterone acetate have specific side effects and safety profiles. Estradiol cypionate can cause breast tenderness, breast enlargement, nausea, headache, and fluid retention. Medroxyprogesterone acetate is generally well-tolerated but can have side effects such as weight gain, mood changes, and menstrual irregularities[2][3].

Regulatory and Clinical Studies

The Women's Health Initiative (WHI) and its substudies have provided significant data on the risks and benefits of estrogen and progestin therapy. These studies have highlighted increased risks of myocardial infarction, stroke, invasive breast cancer, and other conditions associated with combined hormone therapy[3].

Market Trends

The market is trending towards making injectables more accessible through home or self-injection and community-based distribution, especially in low-resource areas. There is also a focus on task-shifting and improving the side-effect profile of these contraceptives[4].

Financial Trajectory

The financial trajectory of the injectable contraceptives market is positive, with a projected growth from USD 352.43 million in 2023 to USD 460.66 million by 2030. This growth is driven by increasing demand, improved accessibility, and ongoing research to enhance these products[1].

Key Takeaways

  • The injectable contraceptives market is growing at a CAGR of 3.9% from 2023 to 2030.
  • Progestogen-only injectables, such as DMPA, dominate the market.
  • Combined injectables like estradiol cypionate and medroxyprogesterone acetate are less common but significant.
  • North America is expected to dominate the market.
  • Research is focused on improving access, reducing side effects, and enhancing drug delivery systems.
  • Key players include major pharmaceutical companies like Pfizer and Merck.

FAQs

What is the current market size of the injectable contraceptives market?

The injectable contraceptives market size was valued at USD 352.43 million in 2023[1].

What is the projected growth rate of the injectable contraceptives market?

The market is expected to grow at a CAGR of 3.9% from 2023 to 2030[1].

Which segment dominates the injectable contraceptives market?

The progestogen-only injectable segment, including products like DMPA, dominates the market[1][4].

What are the common side effects of estradiol cypionate?

Common side effects include breast tenderness, breast enlargement, nausea, headache, and fluid retention[2].

Which regions are expected to dominate the injectable contraceptives market?

North America is expected to dominate the market during the forecast period[1].

Sources

  1. Stellar MR: "Injectable Contraceptives Market - Industry Analysis and Forecast"
  2. Wikipedia: "Estradiol cypionate"
  3. Pfizer: "DEPO®-ESTRADIOL Estradiol cypionate injection, USP"
  4. Maximize Market Research: "Injectable Contraceptives Market: Global Market by Type, Age Group"
  5. Cleveland Clinic: "Estradiol Cypionate; Medroxyprogesterone contraceptive injection"

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