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Last Updated: December 22, 2024

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Drug Patent Profile


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Which patents cover Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate, and what generic alternatives are available?

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate is a drug marketed by Amneal Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Apotex, Barr Labs Inc, and Xiromed. and is included in eleven NDAs.

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

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Summary for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
US Patents:0
Applicants:6
NDAs:11
Finished Product Suppliers / Packagers: 5
What excipients (inactive ingredients) are in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE?NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE excipients list
DailyMed Link:NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE at DailyMed
Drug patent expirations by year for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

US Patents and Regulatory Information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norethindrone Acetate, Ethinyl Estradiol, and Ferrous Fumarate

Introduction

Norethindrone acetate, ethinyl estradiol, and ferrous fumarate is a combination medication widely used as a contraceptive to prevent pregnancy. This article delves into the market dynamics and financial trajectory of this drug, exploring its usage, market trends, and financial performance.

Usage and Mechanism

This combination medication contains two hormones, norethindrone acetate and ethinyl estradiol, which work by preventing the full development of a woman's egg, thereby preventing fertilization and pregnancy. Additionally, it includes ferrous fumarate, an iron supplement, to help maintain iron levels during menstruation[5].

Market Presence and Brand Variations

The drug is available under numerous brand names, including Loestrin 24 Fe, Loestrin Fe 1.5/30, Junel Fe, Microgestin Fe, and many others. This diversity in branding indicates a robust market presence with multiple manufacturers offering the medication[1].

Dosage Forms and Variations

The medication is available in various dosage forms, including tablets and soft gel capsules, each with different hormonal and iron content. For example, the 24-day monophasic tablets contain 1mg of norethindrone acetate and 20mcg of ethinyl estradiol, along with 75mg of ferrous fumarate for the last four days[1].

Side Effects and Precautions

While the medication is effective, it comes with a range of side effects, from common issues like nausea and breast tenderness to more serious conditions such as changes in migraine patterns and breast lumps. It also carries a boxed warning regarding cigarette smoking and serious cardiovascular events, particularly for women over 35 who smoke[1][4].

Market Trends

The global market for ferrous fumarate, a key component of this medication, is driven by the expanding pharmaceutical industry. The ferrous fumarate market is expected to grow significantly due to its application as an iron supplement and its use in various pharmaceutical products. Regions like North America, particularly the U.S., and Asia Pacific, especially India and China, are anticipated to be key drivers of this growth[3].

Financial Performance

The financial performance of norethindrone acetate, ethinyl estradiol, and ferrous fumarate is substantial. For instance, the U.S. annual sales for Taytulla® and its generic equivalents were approximately $124.4 million in the 12 months ended June 2021. This figure indicates a significant market value for these medications[4].

Generic Equivalents and Competition

The launch of generic equivalents, such as Amneal's Taysofy™, which is an AB-rated generic for Taytulla®, further intensifies competition in the market. These generics offer cost-effective alternatives, which can impact the market share of branded products but also contribute to the overall revenue of the medication category[4].

Global Market Analysis

The global pharmaceutical market, valued at over $900 billion, is a major driver for the demand of ferrous fumarate and, by extension, norethindrone acetate, ethinyl estradiol, and ferrous fumarate. Key players in the ferrous fumarate market include Lonye Technology Limited, Allied Biochem Pvt. Ltd., and Galenica Group, among others. These companies play a crucial role in the supply chain and market dynamics of the medication[3].

Regional Market Dynamics

  • North America: This region, led by the U.S., is a significant market due to the presence of major pharmaceutical companies like Johnson & Johnson and Pfizer. The well-established pharmaceutical sector in this region supports the growth of the ferrous fumarate market[3].
  • Asia Pacific: Countries like India and China are driving the growth in this region due to their flourishing pharmaceutical industries. India, in particular, is a major exporter of ferrous fumarate, contributing significantly to the regional market[3].
  • Europe: Countries such as Italy, Germany, and Belgium are key players in the European market, though the demand is expected to be slower compared to other regions[3].

Future Outlook

The future outlook for norethindrone acetate, ethinyl estradiol, and ferrous fumarate is promising, driven by the growing demand for iron supplements and the expanding pharmaceutical industry. As the global population continues to grow and healthcare needs increase, the market for this medication is expected to remain robust.

Key Takeaways

  • Market Presence: The medication is available under multiple brand names and dosage forms.
  • Financial Performance: Significant annual sales, with figures like $124.4 million for Taytulla® and its generics.
  • Market Trends: Driven by the pharmaceutical industry, with North America and Asia Pacific being key regions.
  • Generic Competition: Generic equivalents are increasing competition but also contributing to overall revenue.
  • Future Outlook: Promising due to growing demand for iron supplements and expanding pharmaceutical industry.

FAQs

What is the primary use of norethindrone acetate, ethinyl estradiol, and ferrous fumarate?

The primary use of this combination medication is to prevent pregnancy by stopping the full development of a woman's egg and including an iron supplement to maintain iron levels during menstruation[5].

What are the common side effects of this medication?

Common side effects include nausea, vomiting, abdominal cramps, spotting, changes in menstrual flow, and breast tenderness, among others[1].

What is the significance of ferrous fumarate in this medication?

Ferrous fumarate is an iron supplement included to help maintain iron levels during menstruation. It is odorless, tasteless, and non-toxic, making it a preferred component in pharmaceutical products[3].

How does the presence of generic equivalents impact the market?

Generic equivalents increase competition but also contribute to the overall revenue of the medication category by offering cost-effective alternatives[4].

What regions are expected to drive the growth of the ferrous fumarate market?

North America, particularly the U.S., and Asia Pacific, especially India and China, are expected to be key drivers of the ferrous fumarate market[3].

Sources

  1. RxList: Norethindrone Acetate-Ethinyl Estradiol-Ferrous Fumarate.
  2. DailyMed: Junel® 21 Day (norethindrone acetate and ethinyl estradiol tablets).
  3. Transparency Market Research: Ferrous Fumarate Market - Global Industry Analysis 2024.
  4. RXinsider: Amneal Launches Taysofy™ – Generic for Taytulla.
  5. Mayo Clinic: Norethindrone, ethinyl estradiol, and ferrous fumarate (oral route).

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