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, Encube, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Abbvie, Bayer Hlthcare, Amneal, Mylan Technologies, Zydus Pharms, Parke Davis, Noven, Viatris, 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, Epic Pharma Llc, Lannett Co Inc, Pharmobedient, Rubicon Research, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Millicent Pr, Apil, Dr Reddys, Pharmacia And Upjohn, Watson Labs, Exeltis Usa Inc, Ph Health, Am Regent, Fosun Pharma, Hikma, Xiromed, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Naari Pte, Novast Labs, Aurobindo Pharma Ltd, Sumitomo Pharma Am, and Teva Womens, and is included in ninety 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-eight patent family members in twenty-six countries.

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

Summary for estradiol

International Patents:	188
US Patents:	56
Tradenames:	43
Applicants:	60
NDAs:	90
Drug Master File Entries:	75
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,085
Patent Applications:	7,123
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
University of Utah	PHASE2
University of British Columbia	NA
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE4

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
Teva Pharms Usa	ESTRADIOL	estradiol	CREAM;VAGINAL	210488-001	Mar 30, 2018	AB	RX	No	No
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No
Am Regent	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	090920-001	Jan 19, 2010	AO	RX	No	No
Breckenridge Pharm	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	078324-002	Jun 9, 2011	AB	RX	No	No
Zydus Pharms	ESTRADIOL	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	202985-002	Mar 29, 2023	AB2	RX	No	No
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006		RX	Yes	Yes
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No

Expired US Patents for estradiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006

International Patents for estradiol

Country	Patent Number	Title	Estimated Expiration
Australia	2012340589	Natural combination hormone replacement formulations and therapies
European Patent Office	3560500	PROGESTERONE FORMULATIONS
Japan	6118774
Canada	2942568
Australia	2017206262
Australia	2021218231	Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods
South Korea	20160137597

Supplementary Protection Certificates for estradiol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
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

Market Dynamics and Financial Trajectory for Estradiol Pharmaceuticals

Last updated: July 27, 2025

Introduction

Estradiol, a potent estrogen hormone primarily used in hormone replacement therapy (HRT), contraception, and transgender healthcare, has long maintained a significant position within the global pharmaceutical landscape. Its market dynamics are shaped by demographic shifts, regulatory environments, technological advancements, and evolving therapeutic demands. This analysis offers a comprehensive view of recent trends, competition, regulatory factors, and forecasted financial trajectories shaping the future of estradiol-based therapeutics.

Market Overview and Key Segments

The global estradiol market comprises various formulations, including oral tablets, transdermal patches, gels, creams, vaginal rings, and injections. Each segment addresses specific clinical needs, with transdermal delivery gaining prominence due to improved bioavailability and reduced hepatic first-pass metabolism (1).

According to reports, the global estrogen therapy market, driven chiefly by estradiol formulations, was valued at approximately USD 1.7 billion in 2022 and is poised for a compound annual growth rate (CAGR) of around 4-6% over the next five years (2). The rise is notably linked to increasing aging populations, greater awareness of menopause management, and expanding indications in transgender healthcare.

Drivers of Market Growth

Demographic and Epidemiological Factors

The aging global population significantly propels estradiol demand. Women aged 50+ are more susceptible to menopause-related hormonal imbalances, requiring hormone replacement therapies. The WHO estimates a global menopausal population exceeding 1 billion by 2030, underpinning sustained market growth (3).

Furthermore, rising awareness and acceptance of gender-affirming therapies in transgender individuals bolster demand, especially for estradiol in combination with testosterone blockers (4).

Advancements in Drug Delivery and Formulation Technologies

Innovative delivery systems, such as bioidentical estradiol compounded creams and novel patches, enhance efficacy and patient compliance. The development of bioidentical hormones aligning more closely with endogenous human estrogen improves tolerability and safety profiles, spurring market expansion (5).

Regulatory Environment and Patent Expirations

Patent expirations for leading branded products, coupled with regulatory approvals for generic versions, amplify market penetration. The entry of generics typically reduces costs, enlarging access, especially in emerging markets (6).

Conversely, stringent regulatory landscapes in regions like the US (FDA) and Europe (EMA) impose rigorous safety standards, influencing formulation approvals and market readiness.

Evolving Clinical Guidelines and Safety Perceptions

Heightened awareness around hormone therapy-related risks—such as thromboembolism, breast cancer, and cardiovascular events—has led to refined prescribing guidelines. Emphasis on personalized medicine and tailored dosages aims to optimize benefits while mitigating adverse effects, influencing market dynamics (7).

Competitive Landscape

Major pharmaceutical companies such as Pfizer, Novo Nordisk, and Teva Pharmaceuticals hold prominent positions, offering branded estradiol products supported by extensive marketing and R&D capabilities. The generic market segment continues to grow, intensifying price competition and accessibility.

Additionally, niche players focus on innovative delivery platforms, including microneedle systems and bioengineered estrogens, aiming to capture unmet clinical needs. Strategic alliances, licensing agreements, and acquisitions further shape competitive dynamics.

Regulatory and Legal Factors

Regulatory agencies have increased monitoring of hormone therapies due to safety concerns. The FDA's 2017 guidance on compounded hormone therapies emphasizes ensuring quality and consistency, influencing market practices (8). Countries tightening regulatory controls may delay or restrict approval pathways, impacting revenue forecasts.

Legal disputes over off-label uses and patent rights also influence market stability. Companies investing heavily in R&D for biosimilar estradiol versions anticipate alternative pathways to extend market share amid patent cliffs.

Financial Trajectory

Revenue Forecasts and Market Growth Potential

Estrodiol sales are expected to grow at a CAGR of approximately 4-6% through 2030, driven by demographic trends and expanding clinical applications (2). The regional analysis indicates highest growth potential in Asia-Pacific, Latin America, and the Middle East, where healthcare access expands and regulatory frameworks evolve.

Impact of Generics and Biosimilars

The entrance of biosimilars and generics is projected to reduce prices by 20-40%, potentially expanding market reach but constraining profit margins for branded products (6). The transition emphasizes cost-effective manufacturing and strategic pricing.

Emerging Markets and Price Sensitivity

Emerging economies harbor substantial growth prospects due to increasing healthcare infrastructure investments and rising middle-class populations. However, price sensitivity and regulatory hurdles may temper growth rates, necessitating adaptive marketing strategies.

Investment Trends

Investments in innovative delivery systems and research into bioidentical hormones signal a shift toward value-added products with improved safety, further influencing revenue streams. Mergers and acquisitions aiming to acquire specialized formulations could alter the competitive and financial landscape significantly.

Risks and Challenges

• Safety and Regulatory Scrutiny: Heightened vigilance over hormone-related adverse effects may result in tighter controls, impacting product availability.
• Market Saturation: Mature markets in North America and Europe could face stagnation, requiring diversification into newer formulations or indications.
• Patent Challenges: Expiration of key patents could catalyze fierce price competition from generics.
• Societal and Cultural Factors: Variations in acceptance of hormone therapies globally can influence uptake rates.

Future Outlook

The estradiol market's trajectory appears resilient, buoyed by demographic shifts and expanding indications. Technological innovations, strategic market entries, and regulatory navigation will define the horizon. Companies prioritizing safety profiles and personalized treatment modalities will likely sustain competitive advantages and profitability.

Key Takeaways

• Demographic Trends: Aging populations and increasing transgender healthcare needs underpin sustained demand.
• Innovation Drive: Delivery systems enhancing compliance and safety are central to market expansion.
• Regulatory Landscape: Vigilance regarding safety profiles influences approval pathways and sales strategies.
• Price Dynamics: Generics and biosimilars are reshaping profit margins and accessibility.
• Emerging Markets: High growth potential, contingent on regulatory and economic factors.

FAQs

1. What are the primary therapeutic applications of estradiol?
   Estradiol is predominantly used in hormone replacement therapy for menopausal women, in contraceptive formulations, and in transgender hormone therapies.

2. How do patent expirations influence the estradiol market?
   Patent expirations open the market to generic competitors, reducing prices and increasing accessibility but pressuring branded product revenues.

3. What technological innovations are shaping estradiol delivery?
   Innovations include transdermal patches, bioidentical creams, gels, vaginal rings, and microneedle patches, which improve bioavailability and patient adherence.

4. What safety concerns impact regulatory approval for estradiol therapies?
   Risks such as blood clots, breast cancer, and cardiovascular events lead to stringent safety evaluations, influencing approval and prescribing practices.

5. What is the outlook for estradiol's market growth beyond 2025?
   The market is expected to grow steadily at a CAGR of 4-6%, driven by demographic trends, clinical innovation, and expanding global access, with emerging markets offering significant opportunities.

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References

1. [1] International Journal of Women's Health, 2020. Advances in Estrogen Delivery Technologies.
2. [2] Mordor Intelligence, Estrogen Therapy Market Reports, 2022.
3. [3] WHO, Menopause and the Global Aging Population, 2021.
4. [4] Journal of Clinical Endocrinology & Metabolism, 2021. Transgender Hormone Therapy Market Overview.
5. [5]Pharmaceutical Technology, Innovations in Bioidentical Hormone Formulations, 2022.
6. [6] IQVIA, Impact of Patent Expirations on Hormone Therapies, 2021.
7. [7] FDA, Hormone Therapy Safety Guidelines, 2019.
8. [8] FDA, Guidance on Compounded Hormone Replacement Therapies, 2017.