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Last Updated: December 22, 2024

NORETHINDRONE AND ETHINYL ESTRADIOL Drug Patent Profile


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Which patents cover Norethindrone And Ethinyl Estradiol, and when can generic versions of Norethindrone And Ethinyl Estradiol launch?

Norethindrone And Ethinyl Estradiol is a drug marketed by Watson Labs, Watson Pharms Teva, Dr Reddys Labs Sa, Mylan Labs Ltd, Naari Pte Ltd, Watson Labs Teva, Xiromed, Teva Branded Pharm, Amneal Pharms, Barr, and Lupin Ltd. and is included in twenty-four NDAs.

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

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

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SponsorPhase
University of VirginiaEarly Phase 1
CelerionPhase 1
Achillion, a wholly owned subsidiary of AlexionPhase 1

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US Patents and Regulatory Information for NORETHINDRONE 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
Watson Labs NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-21 078379-001 Feb 23, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Branded Pharm NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 022573-001 Dec 22, 2010 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET;ORAL 202086-001 Apr 1, 2015 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Labs Ltd NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 200489-001 Oct 21, 2015 DISCN 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

NORETHINDRONE AND ETHINYL ESTRADIOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norethindrone and Ethinyl Estradiol

Introduction

Norethindrone and ethinyl estradiol, commonly used in oral contraceptives, are pivotal in the reproductive health market. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The global market for oral contraceptives is substantial and growing, driven by increasing awareness of reproductive health, government initiatives to reduce unintended pregnancies, and the expanding female workforce. Norethindrone and ethinyl estradiol, being key components of many oral contraceptives, play a significant role in this market.

Demand Drivers

Increasing Awareness of Reproductive Health

There is a rising awareness and acceptance of contraceptive methods globally, particularly among younger generations. This trend is fueled by education campaigns and the availability of various contraceptive options, including oral contraceptives containing norethindrone and ethinyl estradiol[2].

Government Initiatives

Many governments around the world have implemented programs to reduce unintended pregnancies and improve maternal health. These initiatives often include subsidies or free access to contraceptive methods, which can increase the demand for norethindrone and ethinyl estradiol-based products.

Expanding Female Workforce

The increasing participation of women in the workforce has led to a greater need for reliable and convenient contraceptive methods. Oral contraceptives, such as those containing norethindrone and ethinyl estradiol, are popular choices due to their effectiveness and ease of use.

Market Challenges

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulatory policies can significantly impact the market. For instance, stricter safety guidelines or changes in approval processes can affect the availability and pricing of norethindrone and ethinyl estradiol products[5].

Side Effects and Health Risks

Oral contraceptives, including those containing norethindrone and ethinyl estradiol, come with potential side effects such as thromboembolic disorders, high blood pressure, and gallbladder disease. These risks can influence consumer choice and regulatory oversight, impacting market dynamics[5].

Competition

The market for oral contraceptives is highly competitive, with numerous brands and generic options available. This competition can drive down prices and affect the financial trajectory of specific products.

Financial Trajectory

Revenue Trends

The revenue generated from norethindrone and ethinyl estradiol products has been stable, with periodic fluctuations due to market competition and regulatory changes. The global oral contraceptive market is expected to continue growing, driven by increasing demand in emerging markets.

Cost Structure

The cost structure for these drugs includes research and development expenses, manufacturing costs, marketing expenditures, and regulatory compliance costs. Generic versions of these drugs can reduce the overall cost for consumers but also impact the revenue of brand-name products.

Pricing Strategies

Pharmaceutical companies employ various pricing strategies to maintain market share. These include competitive pricing, value-based pricing, and tiered pricing to cater to different market segments. For example, generic versions are often priced lower than brand-name products, making them more accessible to a broader audience.

Key Players

Pharmaceutical Companies

Companies like Glenmark Pharmaceuticals, which manufacture and market norethindrone acetate and ethinyl estradiol tablets, play a significant role in the market. These companies invest heavily in research, marketing, and distribution to maintain their market position[2].

Generic Manufacturers

Generic manufacturers also contribute significantly to the market, offering affordable alternatives to brand-name products. This segment is expected to grow as patents expire and more generic options become available.

Market Segmentation

By Region

The market can be segmented by region, with developed countries having a more established market and emerging markets showing significant growth potential. Factors such as healthcare infrastructure, regulatory environment, and economic conditions influence regional market dynamics.

By Product Type

The market can also be segmented by product type, including combination pills (like norethindrone and ethinyl estradiol), progestin-only pills, and extended-cycle pills. Each type has its own market share and growth prospects.

Future Outlook

Technological Advancements

Advancements in drug delivery systems and the development of new formulations can enhance the market for norethindrone and ethinyl estradiol. For example, extended-cycle pills and transdermal patches offer convenience and improved compliance.

Regulatory Changes

Future regulatory changes, such as updates in safety guidelines or approval processes, can impact the market. Companies must stay compliant with these changes to maintain their market presence.

Growing Demand in Emerging Markets

Emerging markets, particularly in Asia and Latin America, are expected to drive future growth due to increasing awareness and access to reproductive health services.

Key Takeaways

  • The market for norethindrone and ethinyl estradiol is driven by increasing awareness of reproductive health, government initiatives, and the expanding female workforce.
  • Regulatory challenges, side effects, and competition are key market challenges.
  • The financial trajectory is influenced by revenue trends, cost structure, and pricing strategies.
  • Key players include pharmaceutical companies and generic manufacturers.
  • Market segmentation by region and product type is crucial for understanding market dynamics.
  • Future growth is expected to be driven by technological advancements, regulatory changes, and growing demand in emerging markets.

FAQs

What are the primary uses of norethindrone and ethinyl estradiol?

Norethindrone and ethinyl estradiol are primarily used for the prevention of pregnancy in women who elect to use oral contraceptives[2].

What are the common side effects of norethindrone and ethinyl estradiol?

Common side effects include thromboembolic disorders, high blood pressure, gallbladder disease, and bleeding irregularities[5].

How do regulatory changes impact the market for norethindrone and ethinyl estradiol?

Regulatory changes can affect the approval process, safety guidelines, and overall availability of these drugs, thereby influencing market dynamics and financial trajectories[5].

What is the role of generic manufacturers in the market?

Generic manufacturers offer affordable alternatives to brand-name products, contributing significantly to the market and impacting the revenue of brand-name products.

How does the growing demand in emerging markets affect the financial trajectory?

The growing demand in emerging markets is expected to drive future growth, increasing revenue and market share for companies that effectively tap into these regions.

Sources

  1. LOESTRIN® 21 (Norethindrone Acetate and Ethinyl Estradiol) Label. FDA.
  2. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablet. DailyMed.
  3. Formation of ethinyl estradiol in women during treatment with norethindrone acetate. PubMed.
  4. Formation of Ethinyl Estradiol in Women during Treatment with Norethindrone Acetate. Journal of Clinical Endocrinology and Metabolism.
  5. Norethindrone, Ethinyl Estradiol and Ferrous Fumarate. Drugs.com.

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