Estradiol; progesterone - Generic Drug Details

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

Estradiol; progesterone is the generic ingredient in two branded drugs marketed by Mayne Pharma and Amneal Pharms, and is included in two NDAs. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol; progesterone has one hundred and seventy-four patent family members in twenty-one countries.

Three suppliers are listed for this compound.

Summary for estradiol; progesterone

International Patents:	174
US Patents:	24
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	288
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for estradiol; progesterone
DailyMed Link:	estradiol; progesterone at DailyMed

Recent Clinical Trials for estradiol; progesterone

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

Sponsor	Phase
University of British Columbia	NA
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	PHASE4
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE4

See all estradiol; progesterone clinical trials

Pharmacology for estradiol; progesterone

Drug Class	Estrogen Progesterone
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for estradiol; progesterone

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

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for ESTRADIOL; PROGESTERONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BIJUVA	Capsules	estradiol; progesterone	1 mg/100 mg	210132	1	2020-01-06

US Patents and Regulatory Information for estradiol; progesterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	8,993,549		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	10,052,386		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	9,301,920		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	8,987,237		Y

International Patents for estradiol; progesterone

Country	Patent Number	Title	Estimated Expiration
Brazil	112014031824	terapias de reposição hormonal transdérmica
Canada	2876947
Australia	2018280270	Vaginal inserted estradiol pharmaceutical compositions and methods
Canada	2876947	TRAITEMENT TRANSDERMIQUE DE SUBSTITUTION HORMONALE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES)

Supplementary Protection Certificates for estradiol; progesterone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
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
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for Estradiol and Progesterone Pharmaceuticals

Last updated: July 29, 2025

Introduction

The global market for hormone therapies, encompassing estradiol and progesterone, stands at a pivotal intersection of demographic shifts, evolving medical guidelines, and technological advancements. These hormones, fundamental in managing menopausal symptoms, hormone replacement therapy (HRT), and certain gynecological conditions, have seen fluctuating demand patterns shaped by regulatory landscapes and innovative pharmaceutical developments. Analyzing market dynamics and forecasting the financial trajectory for these drugs offers critical insights for stakeholders—drug manufacturers, investors, healthcare providers, and policymakers.

Market Overview

Product Profiles

• Estradiol: A potent estrogen primarily used in menopausal HRT, osteoporosis prevention, and transgender hormone therapy. It is available in multiple formulations, including oral, transdermal patches, gels, and injectable forms.

• Progesterone: A progestin used alongside estrogen to mitigate endometrial hyperplasia risks during HRT, treat menstrual disorders, and support fertility treatments. It shares similar diverse delivery mechanisms.

Market Size and Segmentation

The global hormone replacement therapy market was valued at approximately USD 13.2 billion in 2022, with estrogen and progestins constituting a significant share. The compounded annual growth rate (CAGR) of this market is projected at 4.3% from 2023 to 2030, driven by aging populations, increased awareness of menopause management, and expanding indications.

Market Dynamics

Drivers

Demographic Trends

A primary driver is the demographic shift toward an aging population. According to the World Health Organization, the number of women aged 60 and above is expected to double by 2050. This trend directly correlates with increased menopausal and postmenopausal health needs, bolstering demand for estradiol and progesterone therapies.

Clinical Guidelines and Medical Acceptance

Evolving clinical guidelines favor HRT when appropriately prescribed, emphasizing benefit-risk balance. Notably, the Women’s Health Initiative (WHI) studies in the early 2000s initially cast doubt over HRT safety but subsequent analyses and personalized medicine approaches have revitalized confidence, expanding treatment acceptance.

Innovations in Delivery Systems

Advancements such as bioidentical hormone formulations and non-invasive delivery methods improve patient compliance and safety profiles, propelling market growth.

Restraints

Regulatory and Safety Concerns

Concerns over thromboembolic events, breast cancer risks, and cardiovascular complications curtail HRT use, especially in specific patient subsets. Regulatory agencies, like the FDA, have imposed warnings and restrictions that influence prescribing practices.

Availability of Alternatives

The rise of plant-based and herbal alternatives, as well as non-hormonal therapies, pose competitive pressures. Additionally, the development of selective estrogen receptor modulators (SERMs) and tissue-selective agents affect the traditional hormone therapy landscape.

Opportunities

Expanding Indications

Emerging evidence supports the use of estrogen and progesterone in neuroprotective roles, osteoporosis prevention, and symptom management in transgender health, broadening the product application spectrum.

Geographical Growth

Rapid healthcare infrastructure development in Asia-Pacific and Latin America opens new markets. Increasing healthcare expenditure, alongside rising awareness, catalyzes demand growth in these regions.

Competitive Landscape

Key players include Pfizer, Novo Nordisk, Teva Pharmaceuticals, Mylan, and Liuhe Pharmaceutical, among others. Strategic collaborations, mergers, and investments in biosynthetic and novel delivery platforms underpin competitive strategies.

Financial Trajectory and Forecast

Historical Perspectives

Over the past decade, the market demonstrated steady growth, punctuated by innovation cycles and regulatory shifts. Despite temporary setbacks due to safety concerns, the long-term outlook remained positive, underpinned by growing prevalence of menopause-related conditions.

Future Outlook

Forecasts indicate the market could reach approximately USD 18.5 billion by 2030, with a CAGR of 4.3%. The primary acceleration stems from increased global aging populations and expanding indications for hormone therapies.

Impact of Innovation and Personalized Medicine

Personalized hormone formulations tailored to genetic profiles and specific metabolic needs will influence revenue streams. The adoption of bioequivalent generics also sustains market competitiveness and price stabilization.

Pricing and Market Penetration

Despite high demand, pricing strategies face pressure from generic proliferation and regulatory impositions. Price moderation enables wider access, especially in emerging markets, fueling volume-driven revenue.

Regulatory and Policy Impact

Stricter safety regulations and evolving labeling requirements may influence market growth rates but simultaneously incentivize innovation in safer formulations.

Market Challenges and Risks

• Safety and Efficacy Concerns: Ongoing research may redefine risk profiles, affecting demand.
• Regulatory Uncertainties: Policy shifts can delay product approvals and market entry.
• Competitive Market: Innovations and generic entries intensify price competition.

Conclusion

The pharmaceutical industry’s landscape for estradiol and progesterone remains dynamically poised for growth, influenced by demographic changes, scientific advancements, and regulatory evolutions. Strategic engagement with emerging technologies, widening indications, and geographic expansion will shape the future revenue trajectory.

Key Takeaways

• The global demand for estrogen and progestin therapies is set for moderate but sustained growth driven by aging populations and expanding indications.
• Innovations in delivery systems and personalized medicine will provide competitive advantages and open new revenue streams.
• Regulatory and safety concerns necessitate continuous monitoring and adaptation, influencing market stability.
• Emerging markets offer substantial growth opportunities owing to increasing healthcare infrastructure and awareness.
• Strategic collaborations, cost management, and ongoing R&D are vital for maintaining competitive momentum.

FAQs

1. What factors influence the global demand for estradiol and progesterone?
Demographic aging, clinical guidelines endorsing HRT, innovations in drug delivery, and expanding therapeutic indications primarily drive demand.

2. How do safety concerns impact the market trajectory?
Safety issues, notably thromboembolic risks and cancer fears, lead to regulatory restrictions and influence physician prescribing habits, potentially causing demand fluctuations.

3. What role does innovation play in market growth?
Innovations such as bioidentical hormones, transdermal patches, and personalized therapies enhance safety profiles and patient compliance, stimulating market expansion.

4. Which regions are experiencing the fastest growth in hormone therapy markets?
The Asia-Pacific and Latin America regions are witnessing rapid growth due to improving healthcare infrastructure and increasing awareness.

5. How might future regulations affect the market?
Stricter safety regulations could limit product availability temporarily; however, they also foster innovation, encouraging the development of safer formulations that could sustain long-term growth.

References

[1] MarketWatch. “Hormone Replacement Therapy Market Size, Share & Trends Analysis Report,” 2022.
[2] WHO. “Ageing and health,” 2021.
[3] Women’s Health Initiative. “HRT and associated health risks,” 2002-2004.
[4] Frost & Sullivan. “Global Hormone Therapy Market Forecast,” 2023.
[5] FDA. “Hormone Therapy Labeling and Safety,” 2022.