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Last Updated: December 25, 2024

ESTRADIOL AND NORETHINDRONE ACETATE Drug Patent Profile


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

Estradiol And Norethindrone Acetate is a drug marketed by Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Teva Pharms Usa, and Xiromed. and is included in six NDAs.

The generic ingredient in ESTRADIOL AND NORETHINDRONE ACETATE is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Estradiol And Norethindrone Acetate

A generic version of ESTRADIOL AND NORETHINDRONE ACETATE was approved as estradiol; norethindrone acetate by BRECKENRIDGE PHARM on April 17th, 2008.

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Summary for ESTRADIOL AND NORETHINDRONE ACETATE
Drug patent expirations by year for ESTRADIOL AND NORETHINDRONE ACETATE
Recent Clinical Trials for ESTRADIOL AND 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 ESTRADIOL AND NORETHINDRONE ACETATE clinical trials

Pharmacology for ESTRADIOL AND NORETHINDRONE ACETATE
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for ESTRADIOL AND NORETHINDRONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 079193-001 May 11, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 200747-001 Mar 8, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Naari Pte Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210233-001 Feb 28, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261-001 Feb 10, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Breckenridge Pharm ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324-002 Jun 9, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Breckenridge Pharm ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324-001 Apr 17, 2008 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

ESTRADIOL AND NORETHINDRONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estradiol and Norethindrone Acetate

Market Overview

The Estradiol and Norethindrone Acetate drug market is experiencing a period of significant growth, driven by several key factors. This combination drug, which includes estradiol, a synthetic form of the female hormone estrogen, and norethindrone acetate, a progestin, is widely used for managing menopausal symptoms, contraception, and other hormonal imbalances[4].

Market Drivers

Increasing Prevalence of Menopausal Conditions

The primary driver for the Estradiol and Norethindrone Acetate drug market is the increasing prevalence of menopausal and post-menopausal conditions among the aging global population. As women reach menopause, typically between the ages of 45 and 55, they experience a decline in natural estrogen production, leading to symptoms such as hot flashes, night sweats, and vaginal dryness. This demographic shift is driving the demand for effective hormone replacement therapy (HRT) options[4].

Growing Awareness and Acceptance of HRT

The growing awareness and acceptance of HRT as a treatment option for managing menopausal symptoms have been a key factor contributing to the market's expansion. HRT, which involves the administration of synthetic estrogen and progestin, has been shown to provide relief from menopausal symptoms and may also offer potential benefits in maintaining bone health and reducing the risk of certain chronic conditions, such as osteoporosis[4].

Diverse Formulations and Delivery Routes

The availability of diverse formulations and delivery routes of Estradiol and Norethindrone Acetate, including oral, transdermal, and vaginal options, provides healthcare providers and patients with flexibility in treatment choices. This variety enhances patient compliance and satisfaction, further driving market growth[3].

Market Restraints

Potential Side Effects

Despite the benefits, HRT is associated with potential side effects, such as an increased risk of certain medical conditions like vascular disease, stroke, and deep vein thrombosis. These risks can restrain the market's growth, as some patients and healthcare providers may opt for alternative therapies[2][5].

Regulatory and Safety Concerns

Regulatory scrutiny and safety concerns also play a role in shaping the market. For instance, the use of estrogen and progestin combinations is subject to strict guidelines and warnings, particularly regarding the risk of endometrial hyperplasia, breast cancer, and thromboembolic events. These factors can impact market dynamics and influence prescribing patterns[5].

Market Opportunities

Personalized and Tailored Approaches

The growing emphasis on personalized and tailored approaches to menopausal and post-menopausal management presents a significant opportunity for the Estradiol and Norethindrone Acetate drug market. As healthcare providers seek to optimize treatment strategies for individual patients, the demand for flexible and customizable HRT options is expected to increase[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, which could help minimize the risk of systemic side effects[4].

Regional Analysis

North America

North America, particularly the United States, is the largest regional market for Estradiol and Norethindrone Acetate drugs. This is due to the high prevalence of menopausal and post-menopausal conditions, the well-established healthcare infrastructure, and the availability of advanced treatment options[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 and Other Regions

The Asia-Pacific region is also experiencing significant growth, driven by an aging population and increasing healthcare spending. Other regions, including South America and the Middle-East and Africa, are also contributing to the global market growth, albeit at a slower pace[3].

Financial Trajectory

Market Size and Projections

The Estradiol and Norethindrone Acetate drug market has reached a substantial value in recent years and is anticipated to continue its 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].

Revenue Outlook

The revenue outlook for the market is positive, with projections indicating significant expansion. The market size is expected to increase from its current value to several billion USD by the end of the forecast period, driven by the increasing demand for HRT and the introduction of new formulations and delivery mechanisms[3].

Key Players and Market Competition

The market is competitive, with several key players operating globally. These companies are investing in research and development to introduce innovative products and formulations, which is expected to further drive market growth. The competitive landscape is characterized by a mix of established pharmaceutical companies and emerging players, each vying for market share through product differentiation and strategic partnerships[3].

Key Takeaways

  • The Estradiol and Norethindrone Acetate drug market is driven by the increasing prevalence of menopausal and post-menopausal conditions.
  • Growing awareness and acceptance of HRT, along with diverse formulations and delivery routes, are key market drivers.
  • Potential side effects and regulatory concerns are significant restraints.
  • Personalized treatment approaches and novel delivery mechanisms present significant market opportunities.
  • North America and Europe are the largest regional markets, with the Asia-Pacific region showing promising growth.

FAQs

What are the primary indications for Estradiol and Norethindrone Acetate tablets?

Estradiol and Norethindrone Acetate tablets are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis[5].

What are the common adverse reactions associated with Estradiol and Norethindrone Acetate tablets?

Common adverse reactions include back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, and upper respiratory tract infections, among others[5].

How does the market for Estradiol and Norethindrone Acetate drugs vary by region?

North America is the largest market, followed by Europe. The Asia-Pacific region is also growing significantly due to an aging population and increasing healthcare spending[4].

What are the potential side effects of Estradiol and Norethindrone Acetate therapy?

Potential side effects include an increased risk of vascular disease, stroke, deep vein thrombosis, and certain types of cancer, such as breast cancer and endometrial cancer[2][5].

What are the contraindications for Estradiol and Norethindrone Acetate tablets?

Contraindications include undiagnosed abnormal genital bleeding, breast cancer or history of breast cancer, estrogen-dependent neoplasia, active DVT or PE, and active arterial thromboembolic disease[5].

Sources

  1. Market Research Intellect: "Estradiol/Norethindrone Acetate Drug Sales Market Size, Scope And Forecast 2023-2031"
  2. FDA: "LOESTRIN® 21 (Norethindrone Acetate and Ethinyl Estradiol) Label"
  3. Market Research Intellect: "Estradiol & Norethindrone Acetate Drug Market Size, Scope And Forecast 2023-2031"
  4. Data Horizzon Research: "Estradiol Norethindrone Acetate Drug Market Size, Share & Forecast 2024-2031"
  5. DailyMed: "ESTRADIOL AND NORETHINDRONE ACETATE tablet"

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