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Last Updated: December 22, 2024

NORETHINDRONE ACETATE Drug Patent Profile


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When do Norethindrone Acetate patents expire, and when can generic versions of Norethindrone Acetate launch?

Norethindrone Acetate is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Pharms Ltd, Novast Labs, Xiromed, Barr Labs Inc, Dr Reddys Labs Sa, and Apotex. and is included in twenty-nine NDAs.

The generic ingredient in NORETHINDRONE ACETATE 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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Drug patent expirations by year for NORETHINDRONE ACETATE
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Recent Clinical Trials for NORETHINDRONE ACETATE

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

SponsorPhase
Bio Genuine (Shanghai) Biotech Co., Ltd.Phase 3
University of ChicagoPhase 4
Myovant Sciences GmbHPhase 4

See all NORETHINDRONE ACETATE clinical trials

Pharmacology for NORETHINDRONE ACETATE
Drug ClassProgestin

US Patents and Regulatory Information for NORETHINDRONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xiromed NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 202742-001 Oct 30, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 206120-001 Sep 12, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 200275-001 Jul 30, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 202741-001 Feb 20, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 207514-001 Sep 11, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr Labs Inc NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL 076221-001 Nov 6, 2009 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 091090-001 Jul 21, 2010 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

NORETHINDRONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norethindrone Acetate

Introduction

Norethindrone acetate, a synthetic progestogen, is a key component in various hormone replacement therapies (HRT) and contraceptive regimens. This article delves into the market dynamics and financial trajectory of norethindrone acetate, highlighting its current status, growth drivers, challenges, and future outlook.

Market Size and Growth Projections

The global market for norethindrone acetate, particularly when combined with estradiol, is experiencing robust growth. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4% during the forecast period from 2023 to 2031[4].

Key Drivers of Market Growth

Increasing Prevalence of Menopausal and Post-Menopausal Conditions

The primary driver of the norethindrone acetate market is the increasing prevalence of menopausal and post-menopausal conditions among the aging global population. As women reach menopause, they experience a decline in natural estrogen production, leading to symptoms such as hot flashes, night sweats, and vaginal dryness. HRT, which includes norethindrone acetate, is a widely accepted treatment for these symptoms[4].

Growing Awareness and Acceptance of HRT

The growing awareness and acceptance of HRT as an effective treatment option for managing menopausal symptoms have significantly contributed to the market's expansion. HRT not only provides relief from menopausal symptoms but also offers potential benefits in maintaining bone health and reducing the risk of certain chronic conditions like osteoporosis[4].

Diverse Formulations and Delivery Routes

The availability of diverse formulations and delivery routes of norethindrone acetate, including oral, transdermal, and vaginal options, provides healthcare providers and patients with flexibility in treatment choices. This variety enhances patient convenience and potentially improves adherence to therapy[4].

Market Segmentation

By Type

The market is segmented by type, with norethindrone acetate being available in various forms such as tablets and combination therapies with estradiol[1].

By Application

The primary application of norethindrone acetate is in hormone replacement therapy (HRT) for managing menopausal and post-menopausal symptoms. It is also used in the treatment of gynecological disorders and as a contraceptive[2][4].

By Geographical Region

The global market is segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America, particularly the United States, dominates the market due to the high prevalence of menopausal conditions and a well-established healthcare infrastructure. Europe is the second-largest market, while the Asia-Pacific region is expected to witness the fastest growth during the forecast period[4].

Market Opportunities

Personalized and Tailored Approaches to HRT

The growing emphasis on personalized and tailored approaches to menopausal and post-menopausal management presents a significant opportunity for the norethindrone acetate market. Healthcare providers are increasingly seeking to optimize treatment strategies for individual patients, which is expected to increase the demand for flexible and customizable HRT options[4].

Novel Delivery Mechanisms

The development of novel delivery mechanisms, such as transdermal patches or vaginal rings, can enhance patient convenience and potentially improve adherence to therapy. These innovative formulations may also offer more targeted and localized delivery of the active ingredients, potentially minimizing the risk of systemic side effects[4].

Challenges and Restraints

Potential Side Effects

Despite its benefits, norethindrone acetate is associated with potential side effects such as menstrual irregularities, headaches, nausea, breast tenderness, mood changes, and increased risk of certain medical conditions like venous thromboembolism. These side effects can restrain the market's growth to some extent[2][4].

Availability of Alternative Therapies

The availability of alternative therapies for managing menopausal symptoms can also pose a challenge to the growth of the norethindrone acetate market. Patients and healthcare providers may opt for other treatment options that are perceived as safer or more effective[4].

Regional Analysis

North America

North America, particularly the United States, is the largest regional market for norethindrone acetate, driven by the high prevalence of menopausal and post-menopausal conditions and a well-established healthcare infrastructure[4].

Europe

Europe is the second-largest market, with countries like Germany, the United Kingdom, and France contributing significantly to the regional growth. The European market is characterized by a strong regulatory framework, with the European Medicines Agency (EMA) playing a crucial role in the approval and management of HRT products[4].

Asia-Pacific

The Asia-Pacific region is expected to witness the fastest growth during the forecast period, driven by the large patient population, the rising prevalence of menopausal and post-menopausal conditions, and the improving healthcare infrastructure in countries like China, Japan, and India[4].

Future Outlook

The future outlook for the norethindrone acetate market remains positive, driven by the continued need for effective and well-tolerated HRT options. As the global population ages and the number of women experiencing menopausal and post-menopausal conditions increases, the demand for norethindrone acetate and other HRT therapies is expected to remain high.

Personalized Medicine and Innovative Formulations

The growing emphasis on personalized medicine and the development of novel delivery mechanisms will continue to drive market growth. These advancements are expected to enhance patient convenience, improve adherence to therapy, and offer more targeted and localized delivery of the active ingredients[4].

Key Takeaways

  • The norethindrone acetate market is driven by the increasing prevalence of menopausal and post-menopausal conditions.
  • Growing awareness and acceptance of HRT are significant factors contributing to market growth.
  • Diverse formulations and delivery routes provide flexibility in treatment choices.
  • North America dominates the market, with the Asia-Pacific region expected to witness the fastest growth.
  • Personalized and tailored approaches to HRT and novel delivery mechanisms present significant market opportunities.
  • Potential side effects and the availability of alternative therapies are challenges to market growth.

FAQs

What are the primary applications of norethindrone acetate?

Norethindrone acetate is primarily used in hormone replacement therapy (HRT) for managing menopausal and post-menopausal symptoms and in the treatment of gynecological disorders. It is also used as a contraceptive.

What are the key drivers of the norethindrone acetate market?

The key drivers include the increasing prevalence of menopausal and post-menopausal conditions, growing awareness and acceptance of HRT, and the availability of diverse formulations and delivery routes.

What are the potential side effects of norethindrone acetate?

Potential side effects include menstrual irregularities, headaches, nausea, breast tenderness, mood changes, and an increased risk of certain medical conditions like venous thromboembolism.

Which region dominates the norethindrone acetate market?

North America, particularly the United States, dominates the market due to the high prevalence of menopausal conditions and a well-established healthcare infrastructure.

What are the future outlook and opportunities for the norethindrone acetate market?

The future outlook is positive, driven by the need for effective and well-tolerated HRT options. Personalized medicine and innovative formulations, such as transdermal patches or vaginal rings, present significant opportunities for market growth.

Sources

  1. Market Research Intellect: "Estradiol/Norethindrone Acetate Drug Sales Market Size, Scope And Forecast 2023-2031"[1].
  2. Wikipedia: "Norethisterone acetate"[2].
  3. FDA: "204-426 EE NE Clinical PREA"[3].
  4. Data Horizzon Research: "Estradiol Norethindrone Acetate Drug Market Size, Share & Forecast"[4].
  5. Drugs.com: "Norethindrone Tablets: Package Insert / Prescribing Info"[5].

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