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Last Updated: December 22, 2024

NORGESTIMATE AND ETHINYL ESTRADIOL Drug Patent Profile


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When do Norgestimate And Ethinyl Estradiol patents expire, and what generic alternatives are available?

Norgestimate And Ethinyl Estradiol is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Glenmark Speclt, Lupin Ltd, Lupin Pharms, Mylan, Naari Pte Ltd, Watson Labs, and Xiromed. and is included in seventeen NDAs.

The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

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Summary for NORGESTIMATE AND ETHINYL ESTRADIOL
Drug patent expirations by year for NORGESTIMATE AND ETHINYL ESTRADIOL
Recent Clinical Trials for NORGESTIMATE AND ETHINYL ESTRADIOL

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SponsorPhase
Benha UniversityPhase 2/Phase 3
AmgenPhase 1
Gilead SciencesPhase 1

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US Patents and Regulatory Information for NORGESTIMATE AND ETHINYL ESTRADIOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 203870-001 Nov 12, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 205588-001 Apr 26, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200494-001 Jun 17, 2011 AB RX No Yes ⤷  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

NORGESTIMATE AND ETHINYL ESTRADIOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norgestimate and Ethinyl Estradiol

Introduction

Norgestimate and ethinyl estradiol, a combination of hormones used in birth control pills, have been a significant player in the pharmaceutical market. This article delves into the market dynamics, financial trajectory, and various factors influencing the growth of this drug.

Market Size and Growth Projections

The market for norgestimate and ethinyl estradiol has experienced rapid growth in recent years. According to market research, the Ethinyl Estradiol and Norgestimate Market is expected to see sustained and significant expansion from 2023 to 2031. This growth is driven by increasing demand for effective birth control methods and treatments for moderate acne[1].

Market Segmentation

The market is segmented based on type (e.g., 0.035Mg/0.25Mg, 0.035Mg/0.6Mg, 0.025Mg/0.18Mg) and application (contraceptive, moderate acne). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each segment offers unique opportunities and challenges that influence the overall market dynamics[1].

Drivers of Market Growth

Several factors drive the growth of the norgestimate and ethinyl estradiol market:

Increasing Demand for Birth Control

The primary use of norgestimate and ethinyl estradiol is as a combined oral contraceptive (COC), which prevents pregnancy by inhibiting ovulation. The global demand for effective birth control methods continues to rise, particularly in regions with growing populations and increasing awareness about reproductive health[2].

Treatment of Moderate Acne

In addition to its contraceptive benefits, this combination is also used to treat moderate acne in females. This dual functionality enhances its market appeal, especially among younger women who seek both birth control and acne treatment[2].

Advantages Over Older Progestins

Norgestimate, a third-generation progestin, has lower androgenic effects and no estrogenic action compared to older progestins. This makes it more favorable for patients, contributing to its market growth[4].

Restraints and Challenges

Despite the growth potential, there are several restraints and challenges:

Health Risks and Contraindications

The use of norgestimate and ethinyl estradiol is associated with several health risks, including venous and arterial thromboembolism, particularly in women who smoke. Other contraindications include liver disease, uncontrolled hypertension, and a history of certain vascular diseases. These risks necessitate careful patient selection and monitoring[5].

Regulatory Scrutiny

The pharmaceutical industry, including the generic drug market, is subject to stringent regulatory scrutiny. Changes in FDA policies, such as increased scrutiny of generic drug applications, can affect the cost and time required for market entry, potentially impacting the financial trajectory of the drug[3].

Financial Trajectory

The financial trajectory of norgestimate and ethinyl estradiol is influenced by several factors:

Revenue Projections

The market is expected to generate significant revenue throughout the forecast period, driven by the increasing demand for birth control and acne treatment. The detailed market report provides an outlook on the development of the market in terms of revenue, predicting robust growth rates[1].

Competitive Landscape

The market is characterized by a mix of established and emerging players. The entry of generic versions can significantly impact the pricing and profitability of the drug. Generic prices tend to decline with the number of competitors, approaching long-run marginal costs when there are eight or more competitors[3].

Pricing Dynamics

The pricing of norgestimate and ethinyl estradiol is influenced by the number of competitors in the market. As more generic versions enter the market, prices are expected to decrease, which can affect the revenue and profitability of the original branded products[3].

Key Players and Market Entry

The market includes both established pharmaceutical companies and emerging players. The report provides extensive lists of prominent companies, including their market entry year, which is valuable for research and analysis. The entry of new players is influenced by the expected market size and potential profits[1].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the market dynamics. The choice of a hormonal contraceptive is based on individual contraceptive needs, underlying medical conditions, and personal preferences. The dual functionality of norgestimate and ethinyl estradiol as both a contraceptive and an acne treatment makes it a preferred choice for many women[4].

Economic, Political, and Social Landscapes

The economic, political, and social landscapes of different countries also impact the market. Factors such as healthcare policies, insurance coverage, and societal attitudes towards birth control can influence the demand and accessibility of the drug[1].

Conclusion

The market for norgestimate and ethinyl estradiol is poised for significant growth driven by increasing demand for birth control and acne treatment. However, it is also subject to various restraints and challenges, including health risks and regulatory scrutiny. Understanding these market dynamics is crucial for business professionals looking to navigate and capitalize on this market.

Key Takeaways

  • Market Growth: The Ethinyl Estradiol and Norgestimate Market is expected to see sustained growth from 2023 to 2031.
  • Segmentation: The market is segmented by type and application, with geographical divisions.
  • Drivers: Increasing demand for birth control and treatment of moderate acne drive market growth.
  • Restraints: Health risks, contraindications, and regulatory scrutiny are significant challenges.
  • Financial Trajectory: Revenue projections are positive, but pricing dynamics are influenced by competition.
  • Key Players: Both established and emerging players are present in the market.

FAQs

What is the primary use of norgestimate and ethinyl estradiol?

The primary use of norgestimate and ethinyl estradiol is as a combined oral contraceptive (COC) to prevent pregnancy.

What are the health risks associated with norgestimate and ethinyl estradiol?

The health risks include venous and arterial thromboembolism, liver disease, uncontrolled hypertension, and certain vascular diseases.

How does the entry of generic versions affect the market?

The entry of generic versions can lead to a decrease in prices as competition increases, approaching long-run marginal costs with multiple competitors.

What are the advantages of norgestimate over older progestins?

Norgestimate has lower androgenic effects and no estrogenic action compared to older progestins, making it more favorable for patients.

Can norgestimate and ethinyl estradiol be used during breastfeeding?

There are no adequate studies to determine the infant risk when using this medication during breastfeeding, so it is generally advised to weigh the potential benefits against the potential risks[2].

Sources

  1. Market Research Intellect: Ethinyl Estradiol and Norgestimate Market Size, Scope And Forecast.
  2. Mayo Clinic: Ethinyl estradiol and norgestimate (oral route).
  3. Federal Trade Commission: Generic Drug Industry Dynamics.
  4. Elsevier Healthcare Hub: Norgestimate; Ethinyl Estradiol.
  5. Drugs.com: Norgestimate and Ethinyl Estradiol: Package Insert / Prescribing Info.

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