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Last Updated: December 22, 2024

ETHINYL ESTRADIOL; NORGESTIMATE - Generic Drug Details


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

Ethinyl estradiol; norgestimate is the generic ingredient in nineteen branded drugs marketed by Janssen Pharms, Xiromed, Aurobindo Pharma Ltd, Novast Labs Ltd, Amneal Pharms, Glenmark Pharms Ltd, Glenmark Speclt, Lupin Ltd, Lupin Pharms, Mylan, Naari Pte Ltd, Watson Labs, Endo Operations, Barr, Barr Labs Inc, Novast Labs, and Aurobindo Pharma, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-one suppliers are listed for this compound.

Recent Clinical Trials for ETHINYL ESTRADIOL; NORGESTIMATE

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

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

See all ETHINYL ESTRADIOL; NORGESTIMATE clinical trials

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORGESTIMATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 201896-001 Jan 27, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Pharms NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200541-001 Jun 25, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd MILI ethinyl estradiol; norgestimate TABLET;ORAL-28 205449-001 Jul 7, 2016 AB RX No 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

Expired US Patents for ETHINYL ESTRADIOL; NORGESTIMATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ⤷  Subscribe ⤷  Subscribe
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 ⤷  Subscribe ⤷  Subscribe
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

ETHINYL ESTRADIOL; NORGESTIMATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ethinyl Estradiol and Norgestimate

Introduction

Ethinyl estradiol and norgestimate, a combination of hormones used in oral contraceptives, have been experiencing significant growth in the pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the Ethinyl Estradiol and Norgestimate market.

Market Size and Growth Projections

The Ethinyl Estradiol and Norgestimate market has seen a rapid and substantial surge in recent years. Projections indicate a sustained and significant expansion from 2023 to 2031. The market is expected to register robust growth rates throughout the forecasted period, driven by positive market dynamics and prolonged expansion[1][3][4].

Market Segmentation

The market is segmented based on several key factors:

By Type

  • 0.035Mg/0.25Mg
  • 0.035Mg/0.6Mg
  • 0.025Mg/0.18Mg
  • Other formulations

By Application

  • Contraceptive
  • Moderate Acne

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa

This segmentation provides a comprehensive analysis of the market from various perspectives, including product types, applications, and geographical regions[1][3][4].

Market Drivers

Several factors are driving the growth of the Ethinyl Estradiol and Norgestimate market:

Increasing Demand for Contraceptives

The global demand for effective and safe contraceptive methods is on the rise, particularly among younger demographics. Ethinyl estradiol and norgestimate combination pills are highly effective in preventing pregnancy, making them a popular choice[4].

Expanding Applications

Beyond contraception, these hormones are also used to treat symptoms of premenstrual dysphoric disorder (PMDD) and to reduce the risk of endometrial and ovarian cancers. This broader range of applications contributes to the market's growth[4].

Pharmaceutical Innovations

The introduction of new products and formulations by major pharmaceutical companies such as Pfizer, Teva, and Gedeon Richter is expanding the market. These innovations provide more choices and convenience for consumers, further driving market growth[4].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

Side Effects and Health Risks

Common side effects such as nausea, headaches, bloating, and mood changes, as well as more serious risks like increased blood pressure, stroke, heart attack, and blood clots, can deter some users. These health concerns need to be carefully managed and communicated to potential users[4].

Regulatory Challenges

Pharmaceutical products are subject to stringent regulatory requirements. Changes in regulatory policies or increased scrutiny can impact the market's growth. Companies must navigate these challenges to maintain market share[1][3].

Market Opportunities

The Ethinyl Estradiol and Norgestimate market presents several opportunities:

Emerging Markets

Geographical regions such as Asia-Pacific and South America offer significant growth potential due to increasing healthcare awareness and access to contraceptive methods. Companies can expand their market presence by targeting these regions[1][3].

Generic and Brand-Name Options

The availability of both generic and brand-name versions of ethinyl estradiol and norgestimate products provides a range of options for consumers, which can drive market growth. Companies like Teva and Pfizer are capitalizing on this by offering both generic and branded products[4].

Key Players

Several key players are prominent in the Ethinyl Estradiol and Norgestimate market:

Pfizer

Known for its product Lo Loestrin FE, Pfizer is one of the leading companies in this market segment[4].

Teva Pharmaceuticals

Teva offers products like Camrese and other formulations containing ethinyl estradiol and norgestimate, both in generic and brand-name forms[4].

Gedeon Richter

Richter’s product, Estrostep Fe, is another notable offering in this market[4].

Other Companies

Companies such as Aurobindo Pharma, Lupin, Glenmark Pharma, and Amneal Pharma are also significant players, contributing to the market's diversity and competitiveness[3].

Financial Trajectory

The financial outlook for the Ethinyl Estradiol and Norgestimate market is promising:

Revenue Projections

The market is anticipated to reach significant revenue milestones by 2030, with a compounded annual growth rate (CAGR) that reflects robust growth throughout the forecast period[1][3][4].

Investment and Innovation

Continuous investment in research and development by key players is expected to drive innovation, leading to new products and formulations that will further boost market revenue.

Pharmacokinetics and Efficacy

The efficacy and tolerability of ethinyl estradiol and norgestimate have been well-documented. A large-scale open-label study involving 59,701 women demonstrated a use-efficacy Pearl index of 0.25 pregnancies per 100 woman-years, indicating high effectiveness. The study also showed minimal effects on weight, blood pressure, pulse, lipid metabolism, and blood glucose[2].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the market dynamics:

Preference for Convenience

Consumers increasingly prefer convenient and effective contraceptive methods. The once-daily oral administration of ethinyl estradiol and norgestimate aligns with this preference, contributing to its popularity[4].

Awareness and Education

Increased awareness about the benefits and risks of hormonal contraceptives is driving consumer demand. Educational campaigns and healthcare provider recommendations also influence consumer choices.

Economic, Political, and Social Landscapes

The market is influenced by broader economic, political, and social factors:

Economic Factors

Economic stability and healthcare spending in various regions impact the market's growth. Regions with strong healthcare systems and higher spending on pharmaceuticals tend to drive market expansion[1][3].

Political Factors

Regulatory policies and government initiatives related to healthcare and reproductive health can significantly influence the market. Favorable policies can boost market growth, while stringent regulations can pose challenges[1][3].

Social Factors

Social attitudes towards contraception and women's health also play a role. Increasing acceptance and awareness of contraceptive methods contribute to the market's growth[4].

Key Takeaways

  • Robust Growth: The Ethinyl Estradiol and Norgestimate market is expected to experience robust growth from 2023 to 2031.
  • Segmentation: The market is segmented by type, application, and geography, providing a comprehensive analysis.
  • Drivers: Increasing demand for contraceptives, expanding applications, and pharmaceutical innovations drive market growth.
  • Restraints: Side effects, health risks, and regulatory challenges are key restraints.
  • Opportunities: Emerging markets, generic and brand-name options, and continuous innovation offer significant opportunities.
  • Key Players: Companies like Pfizer, Teva, and Gedeon Richter are leading the market.

FAQs

Q: What are the primary applications of Ethinyl Estradiol and Norgestimate? A: The primary applications include contraception and the treatment of moderate acne, as well as symptoms of premenstrual dysphoric disorder (PMDD)[4].

Q: Which companies are leading the Ethinyl Estradiol and Norgestimate market? A: Key players include Pfizer, Teva Pharmaceuticals, Gedeon Richter, and other significant companies like Aurobindo Pharma and Lupin[3][4].

Q: What are the common side effects of Ethinyl Estradiol and Norgestimate? A: Common side effects include nausea, headaches, bloating, breast tenderness, and mood changes. Serious risks include increased blood pressure, stroke, heart attack, and blood clots[4].

Q: How is the market segmented? A: The market is segmented by type (different dosages), application (contraceptive, moderate acne), and geography (North America, Europe, Asia-Pacific, etc.)[1][3].

Q: What is the financial outlook for the Ethinyl Estradiol and Norgestimate market? A: The market is anticipated to reach significant revenue milestones by 2030, with a robust CAGR throughout the forecast period[1][3][4].

Sources

  1. Market Research Intellect - Global Ethinyl Estradiol and Norgestimate Market Size, Scope And Forecast[1].
  2. PubMed - The efficacy and tolerability of norgestimate/ethinyl estradiol[2].
  3. Market Research Intellect - Mercado de etinilestradiol y norgestimato[3].
  4. Mobility Foresights - Global Ethinyl Estradiol And Norgestimate Market 2024-2030[4].

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