Estradiol acetate - Generic Drug Details

What are the generic sources for estradiol acetate and what is the scope of patent protection?

Estradiol acetate is the generic ingredient in two branded drugs marketed by Millicent and Apil, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol acetate has eleven patent family members in ten countries.

One supplier is listed for this compound.

Summary for estradiol acetate

International Patents:	11
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	119
Patent Applications:	893
What excipients (inactive ingredients) are in estradiol acetate?	estradiol acetate excipients list
DailyMed Link:	estradiol acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for estradiol acetate

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for estradiol acetate

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

Sponsor	Phase
Bio Genuine (Shanghai) Biotech Co., Ltd.	Phase 3
University of Chicago	Phase 4
Myovant Sciences GmbH	Phase 4

See all estradiol acetate clinical trials

Pharmacology for estradiol acetate

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for estradiol acetate

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for estradiol acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003		RX	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003		RX	Yes	Yes

Expired US Patents for estradiol acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003

International Patents for estradiol acetate

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04006057	PRODUCTOS FARMACEUTICOS ORALES QUE CONTIENEN 3-ALCANOATO INFERIOR DE 17-BETA-ESTRADIOL, METODO PARA ADMINISTRAR LOS MISMOS Y PROCESO DE PREPARACION. (ORAL PHARMACEUTICAL PRODUCTS CONTAINING 17beta-ESTRADIOL-3-LOWER ALKANOATE, METHOD OF ADMINISTERING THE SAME AND PROCESS OF PREPARATION.)
China	1273141
Norway	20042565
Australia	2002359758
Japan	2005517673
China	1564689
Israel	160797	תכשירי רוקחות לצריכה דרך הפה המכילים ב-17-אסטרדיול-3-אצטאט, שיטה להכנתם ושימוש ב-ב-17-אסטרדיול-3-אצטאט להכנתם (Oral pharmaceutical products containing 17beta-estradiol-3-acetate, process of preparation of the same and use of 17-beta-estradiol-3-acetate in the preparation of the same)

Supplementary Protection Certificates for estradiol acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Estradiol acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estradiol Norethindrone Acetate Drugs

Market Overview

The market for Estradiol Norethindrone Acetate drugs is experiencing significant growth, driven by several key factors. This market is part of the broader hormone replacement therapy (HRT) sector, which is expanding due to the increasing prevalence of menopausal and post-menopausal conditions globally[1][3][4].

Market Drivers

Increasing Prevalence of Menopausal Conditions

The primary driver for the Estradiol Norethindrone Acetate Drug market is the rising prevalence of menopausal and post-menopausal conditions among the aging global population. As women age, 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 HRT solutions[1].

Growing Awareness and Acceptance of HRT

The growing awareness and acceptance of HRT as a treatment option for managing menopausal symptoms have also contributed to the market's expansion. HRT, which includes the administration of synthetic estrogen and progestin (such as Estradiol Norethindrone Acetate), offers relief from menopausal symptoms and potential benefits in maintaining bone health and reducing the risk of certain chronic conditions like osteoporosis[1].

Diverse Formulations and Delivery Routes

The availability of diverse formulations and delivery routes, 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[1].

Market Restraints

Potential Side Effects and Alternative Therapies

Despite the growth drivers, the market faces restraints such as potential side effects associated with HRT, including an increased risk of certain medical conditions. Additionally, the availability of alternative therapies may deter some patients from opting for Estradiol Norethindrone Acetate[1].

Reimbursement and Insurance Challenges

Challenges related to reimbursements and insurance coverage can also impact the sales trajectory of hormone therapies. Price sensitivity among consumers is another factor that can restrain the growth potential for combination hormone therapies[4].

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 Norethindrone Acetate Drug market. The demand for flexible and customizable HRT options is expected to increase as healthcare providers seek to optimize treatment strategies for individual patients[1].

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, minimizing the risk of systemic side effects[1].

Healthcare Policy Changes and Digital Media

Opportunities also exist within healthcare policy changes and the use of digital media to amplify educational efforts regarding Estradiol Norethindrone Acetate. Strategically positioning these drugs within next-gen women's health solutions can further boost market presence[4].

Regional Analysis

North America

North America, particularly the United States, dominates the global Estradiol Norethindrone Acetate Drug market. This is due to the high prevalence of menopausal and post-menopausal conditions and the well-established healthcare infrastructure in the region[1].

Europe

Europe is the second-largest market, with countries like Germany, the United Kingdom, and France contributing significantly to 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[1].

Asia-Pacific

The Asia-Pacific region is expected to witness the fastest growth during the forecast period, driven by the large patient population, rising prevalence of menopausal and post-menopausal conditions, and improving healthcare infrastructure in countries like China, Japan, and India[1].

Latin America and Middle East & Africa

These regions also present opportunities for growth, albeit at a relatively slower pace, as awareness and access to healthcare services continue to improve. However, economic and political instability, as well as limited healthcare resources, may pose challenges in these markets[1].

Financial Trajectory

Market Size and Growth Rate

The global Estradiol Norethindrone Acetate Drug market is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4% during the forecast period. The market size is anticipated to expand significantly, reaching USD billions by the end of the forecast period[1][3].

Revenue Projections

Recent years have witnessed a substantial surge in the Estradiol Norethindrone Acetate Drug market, with projections indicating continued and significant expansion from 2023 to 2031. The market dynamics, including drivers, restraints, opportunities, and challenges, are meticulously scrutinized to understand their collective impact on revenue growth[3].

Cost and Insurance Considerations

The cost of Estradiol Norethindrone Acetate drugs can be significant, with many claims costing $134 or more to the claimant. Female claimants often pay a higher share of the claim costs for estrogens and progestins compared to male claimants, highlighting the need for further research into cost disparities and insurance coverage[5].

Future Outlook

The future outlook for the Estradiol Norethindrone Acetate Drug 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 conditions increases, the demand for Estradiol Norethindrone Acetate and other HRT therapies is expected to remain high. The emphasis on personalized treatment approaches and the development of novel delivery mechanisms will continue to drive market growth[1].

Key Takeaways

• The Estradiol Norethindrone Acetate Drug market is driven by the increasing prevalence of menopausal and post-menopausal conditions.
• Growing awareness and acceptance of HRT are key factors contributing to market expansion.
• Diverse formulations and delivery routes enhance patient convenience and adherence.
• Potential side effects and alternative therapies are market restraints.
• Personalized treatment approaches and novel delivery mechanisms present significant opportunities.
• North America and Europe are major markets, with the Asia-Pacific region expected to grow rapidly.

Frequently Asked Questions (FAQs)

Q: What are the primary drivers of the Estradiol Norethindrone Acetate Drug market? A: The primary drivers include the increasing prevalence of menopausal and post-menopausal conditions and the growing awareness and acceptance of HRT as an effective treatment option[1].

Q: What are the different formulations and delivery routes available for Estradiol Norethindrone Acetate? A: The drug is available in various formulations, including oral, transdermal, and vaginal options, providing flexibility in treatment choices[1].

Q: Which regions dominate the global Estradiol Norethindrone Acetate Drug market? A: North America, particularly the United States, and Europe are the dominant regions, with the Asia-Pacific region expected to witness the fastest growth[1].

Q: What are the potential restraints to the market growth? A: Potential side effects associated with HRT, alternative therapies, and challenges related to reimbursements and insurance coverage are significant restraints[1][4].

Q: How is the future outlook for the Estradiol Norethindrone Acetate Drug market? A: The future outlook is positive, driven by the continued need for effective and well-tolerated HRT options and the emphasis on personalized treatment approaches and novel delivery mechanisms[1].

Cited Sources:

1. DataHorizon Research: Estradiol Norethindrone Acetate Drug Market Size, Share & Forecast.
2. DrugBank: Estradiol acetate: Uses, Interactions, Mechanism of Action.
3. Market Research Intellect: Estradiol & Norethindrone Acetate Drug Market Size, Scope And Forecast.
4. 360iResearch: Estradiol-Norethindrone Acetate Tablets Market 2025-2030.
5. Oregon Health Authority: Hormone Replacement Therapy Drug Costs Study – 2022.