ESTRADIOL - Generic Drug Details

What are the generic drug sources for estradiol and what is the scope of freedom to operate?

Estradiol is the generic ingredient in forty-three branded drugs marketed by Allergan, Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Abbvie, Bayer Hlthcare, Amneal, Mylan Technologies, Zydus Pharms, Parke Davis, Noven, Mylan Speciality Lp, Novitium Pharma, Solaris Pharma Corp, Ascend Theraps Us, Vertical Pharms, Chemo Research Sl, Quagen, Pfizer, Mayne Pharma, Padagis Us, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, Sandoz, Bristol Myers Squibb, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Norvium Bioscience, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Millicent, Apil, Dr Reddys, Pharmacia And Upjohn, Watson Labs, Exeltis Usa Inc, Endo Operations, Am Regent, Fosun Pharma, Hikma, Xiromed, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Sumitomo Pharma, and Teva Womens, and is included in eighty-nine NDAs. There are fifty-six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Estradiol has one hundred and eighty-five patent family members in twenty-six countries.

There are seventy-five drug master file entries for estradiol. Forty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ESTRADIOL

International Patents:	185
US Patents:	56
Tradenames:	43
Applicants:	60
NDAs:	89
Drug Master File Entries:	75
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	1,002
Patent Applications:	7,081
Drug Prices:	Drug price trends for ESTRADIOL
Drug Sales Revenues:	Drug sales revenues for ESTRADIOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESTRADIOL
What excipients (inactive ingredients) are in ESTRADIOL?	ESTRADIOL excipients list
DailyMed Link:	ESTRADIOL at DailyMed

See drug prices for ESTRADIOL

See drug sales revenues for ESTRADIOL

Recent Clinical Trials for ESTRADIOL

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

Sponsor	Phase
Anna Stanhewicz, PhD	Early Phase 1
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Alexion Pharmaceuticals, Inc.	Phase 1

See all ESTRADIOL clinical trials

Generic filers with tentative approvals for ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
		3MG;2MG;3MG	TABLET;ORAL
		1MG;2MG;2MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ESTRADIOL

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for ESTRADIOL

Estrogens

Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL

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

Paragraph IV (Patent) Challenges for ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMVEXXY	Vaginal Inserts	estradiol	4 mcg and 10 mcg	208564	1	2019-12-30
MINIVELLE	Transdermal System	estradiol	0.025 mg/day	203752	1	2015-05-08
MINIVELLE	Transdermal System	estradiol	0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day	203752	1	2014-08-18
VAGIFEM	Vaginal Tablets	estradiol	10 mcg	020908	1	2013-01-02
VIVELLE-DOT	Transdermal System	estradiol	0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day	020538	1	2010-04-27
CLIMARA	Transdermal System	estradiol	0.05 mg/day and 0.1 mg/day	020375		2005-09-12

US Patents and Regulatory Information for ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-001	Dec 20, 1996		DISCN	No	No
Endo Operations	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Mylan Technologies	ESTRADIOL	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	206685-001	Aug 15, 2018	AB3	RX	No	No
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	AB	RX	Yes	Yes

Expired US Patents for ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-005	Aug 4, 1998	4,842,864
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-002	Oct 28, 1994	5,300,291
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996	4,906,463
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994	4,994,267

International Patents for ESTRADIOL

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3560500	FORMULATIONS DE PROGESTÉRONE (PROGESTERONE FORMULATIONS)
Israel	236359
Australia	2017208300	Soluble Estradiol Capsule For Vaginal Insertion
Japan	2018538290

Supplementary Protection Certificates for ESTRADIOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103

ESTRADIOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estradiol

Introduction

Estradiol, a key hormone in hormone replacement therapy (HRT), is witnessing significant growth in the global market, driven by increasing demand for treatments addressing menopausal symptoms and other hormonal imbalances. Here, we delve into the market dynamics and financial trajectory of estradiol, particularly focusing on its various forms such as gels and transdermal patches.

Market Size and Growth

The global estradiol gel market, for instance, was valued at US$ 79 million in 2023 and is anticipated to reach US$ 127 million by 2030, with a compound annual growth rate (CAGR) of 7.3% during the forecast period 2024-2030[1].

Similarly, the estradiol transdermal patches market is expected to see substantial growth. Although the exact market size for 2023 is not specified, the market is projected to expand significantly from 2023 to 2031, driven by increasing awareness and acceptance of HRT[3][4].

Drivers of Growth

Increasing Incidence of Menopausal Symptoms

The rising incidence of menopausal symptoms such as hot flashes, vaginal dryness, and mood swings is a primary driver of the estradiol market. As women live longer and remain more active into later life stages, the demand for treatments that alleviate these symptoms is on the rise[1].

Changing Cultural Views

Shifting cultural views toward women's health and menopause are also contributing to market growth. Menopause is increasingly seen as a normal stage of life rather than a disease, leading to greater acceptance and use of HRT products like estradiol gel and transdermal patches[1].

Aging Population

The aging population, particularly in regions like North America, Europe, and the Asia-Pacific, is another significant factor. Countries such as South Korea and Japan, with rapidly aging populations, are expected to drive market expansion as more women seek effective treatments for menopausal symptoms[1].

Regional Market Dynamics

North America

North America is a well-established market for estradiol products, driven by a high number of women experiencing menopause and a strong healthcare infrastructure that supports industry growth[1].

Europe

Europe also sees significant demand due to its aging population and progressive views on women's health. The region's healthcare infrastructure further supports the market expansion[1].

Asia-Pacific

The Asia-Pacific region offers substantial growth opportunities, particularly in countries like South Korea and Japan. As awareness of menopausal health issues and HRT increases, the demand for estradiol products is expected to rise[1].

Competitive Landscape

The estradiol market is competitive, with several key players:

• Estradiol Gel Market: Companies such as Vertical Pharmaceuticals, LLC, Meda Pharmaceutical, Ascend Therapeutics, Abbott, BSV Group, and Wuhan Jianmin Group are prominent in this segment[1].
• Estradiol Transdermal Patches Market: Key companies include Novartis, Bayer Healthcare Pharmaceuticals, Watson Labs, Women First Healthcare Inc, Noven, AbbVie, Lumara Health, and ANI Pharmaceuticals[3][4].

Financial Performance

Revenue and Sales

The financial performance of companies in the estradiol market is robust, with significant revenue growth. For example, Fuji Pharma Co., Ltd. reported a record high in consolidated sales of JPY40.9 billion in the fiscal year ending September 30, 2023, partly due to the growth in women's healthcare products, including hormone replacement therapies[2].

Research and Development

Investments in research and development are also driving financial growth. Companies are focusing on new products and approvals, such as Fuji Pharma's FSN-013 and the biosimilar ustekinumab, which contribute to increased revenues and profitability[2].

Market Segments

By Type

• Estradiol Gel: Segmented by type (skin administration, vaginal administration) and application (pharmacy sales, online sales)[1].
• Estradiol Transdermal Patches: Segmented by type (25 mg/day, 50 mg/day, 75 mg/day, 100 mg/day) and application (male, female), although the male application is less common[3][4].

By Geography

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its unique dynamics and growth prospects[1][3][4].

Challenges and Opportunities

Regulatory Hurdles

Regulatory challenges can impact market growth. However, as regulatory hurdles are removed and healthcare infrastructure improves, especially in the Asia-Pacific region, the market is expected to expand further[1].

Increasing Awareness

Increasing awareness of menopausal health and HRT among both healthcare providers and patients presents a significant opportunity for market growth. Educational initiatives and marketing campaigns can further drive this awareness[1].

Consumer Behavior

Consumer behavior is shifting toward more proactive management of menopausal health. Women are seeking effective and convenient treatment options, which has led to a preference for transdermal products like estradiol gels and patches due to their ease of use and consistent absorption rates[1][3].

Technological Trends

Advancements in drug delivery systems, such as transdermal patches, are enhancing the efficacy and convenience of estradiol treatments. These technological trends are expected to continue driving market growth as they offer better patient outcomes and compliance[4].

Key Takeaways

• The estradiol market, including gels and transdermal patches, is growing significantly due to increasing demand for HRT.
• The market is driven by the rising incidence of menopausal symptoms, changing cultural views, and an aging population.
• North America, Europe, and the Asia-Pacific are key regions driving market growth.
• The competitive landscape includes several major pharmaceutical companies.
• Financial performance is robust, with significant revenue growth and investments in R&D.
• Market segments are defined by type, application, and geography.

FAQs

Q: What is the projected CAGR for the estradiol gel market from 2024 to 2030? A: The estradiol gel market is anticipated to witness a CAGR of 7.3% during the forecast period 2024-2030[1].

Q: Which regions are expected to drive the growth of the estradiol market? A: North America, Europe, and the Asia-Pacific are expected to be key drivers of the estradiol market growth[1].

Q: What are the main types of estradiol transdermal patches available in the market? A: The main types include 25 mg/day, 50 mg/day, 75 mg/day, and 100 mg/day[3][4].

Q: Who are some of the key players in the estradiol market? A: Key players include Vertical Pharmaceuticals, LLC, Meda Pharmaceutical, Ascend Therapeutics, Abbott, BSV Group, Wuhan Jianmin Group, Novartis, Bayer Healthcare Pharmaceuticals, and others[1][3][4].

Q: What are the primary drivers of the estradiol market growth? A: The primary drivers include the increasing incidence of menopausal symptoms, changing cultural views toward women's health, and an aging population[1].

Sources

1. Global Estradiol Gel Market Research Report 2024 - Valuates Reports
2. Financial Results Briefing for the Fiscal Year Ending September 30, 2023 - Fuji Pharma Co., Ltd.
3. Estradiol Transdermal Patches Market Size, Scope And Forecast - Market Research Intellect
4. Estradiol Transdermal Patches Market Report 2024 (Global Edition) - Cognitive Market Research