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.

Two 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:	2
Clinical Trials:	290
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
Exeltis	PHASE4
National Institute on Aging (NIA)	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	210132-001	Oct 28, 2018		RX	Yes	Yes			Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No			Y
Amneal Pharms	ESTRADIOL AND PROGESTERONE	estradiol; progesterone	CAPSULE;ORAL	214293-001	May 16, 2022		DISCN	No	No
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y

International Patents for estradiol; progesterone

Country	Patent Number	Title	Estimated Expiration
South Korea	20150032560
Portugal	2782584
Canada	3045024
South Korea	20180100567	질 삽입식 에스트라디올 약제학적 조성물 및 방법

Supplementary Protection Certificates for estradiol; progesterone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-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 20210701
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307

Market Dynamics and Financial Trajectory for Estradiol and Progesterone

Last updated: February 16, 2026

The combination of estradiol and progesterone represents a segment within hormone therapy (HT), primarily used for menopausal symptom management, contraception, and hormone replacement therapy (HRT). Market valuation hinges on aging demographics, regulatory approvals, clinical demand, and biosimilar entry.

Market Overview

The global hormone therapy market was valued at approximately USD 15.7 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 4.5% from 2023 to 2030, reaching an estimated USD 22 billion.

Estradiol (E2) remains the most commonly prescribed estrogen, while progesterone is usually combined for HRT or contraceptive indications. The market is dominated by well-established pharmaceutical multinationals such as Pfizer, Bayer, and Novo Nordisk.

Key Market Drivers

1. Aging Population: The global population aged 55 and above is expected to increase to 1.4 billion by 2030. The rising prevalence of menopausal symptoms fuels demand for E2 and progesterone-based therapies.

2. Regulatory Approvals and Labeling: Expanded indications, especially for bioidentical formulations, increase market penetration. Recently, FDA approval of oral estradiol and progesterone formulations for menopausal symptoms bolstered market growth.

3. Shift Toward Bioidentical and Custom Hormone Formulations: Patients favor bioidentical hormones due to perceived safety benefits. This trend stimulates innovation and new product launches.

4. Contraceptive Market Growth: Progesterone formulations, especially long-acting reversible contraceptives (LARCs), expand the market. The increasing global fertility rates in developing countries contribute to rising sales.

5. Biosimilars and Generics: Patent expirations in the late 2010s paved the way for biosimilar entrants, applying downward price pressures but increasing volume sales.

Market Segments and Revenue Contributions

Segment	Estimated 2022 Revenue	CAGR (2023-2030)	Notes
Menopausal Hormone Therapy	USD 8.4 billion	4.7%	Largest contributor, driven by demographic shifts
Contraceptive Products	USD 3.5 billion	3.9%	Driven by global contraceptive use; largest in emerging markets
HRT for Other Indications	USD 1.8 billion	4.2%	Includes osteoporosis and sexual health products
Biosimilar and Generic Sales	USD 1.0 billion	6.1%	Rapidly growing segment due to patent expirations

Key Players and Competitive Landscape

• Pfizer: Leader with Premarin and bioidentical formulations.
• Bayer: Strong presence in contraceptive hormones.
• Novo Nordisk: Growing biosimilar portfolio.
• Teva Pharmaceuticals: Focus on generics and biosimilars.
• Women’s health specialty companies have increased R&D investments to develop novel delivery systems such as transdermal patches, gels, and subcutaneous implants.

Regulatory Environment and Impact

Changes in regulatory landscapes significantly influence market trajectory. The US FDA has increased scrutiny over compounded bioidentical hormones, favoring approved formulations that meet safety and efficacy standards. European agencies like EMA have provided clear pathways for biosimilar approvals, incentivizing generic hormone formulations.

Financial Outlook

The market for estradiol and progesterone combination therapies is expected to sustain mid-single-digit growth over the next decade. Revenues are projected to approach USD 22 billion by 2030 globally, driven primarily by increased utilization in older populations and expanding contraceptive markets.

Generic and biosimilar entries will exert price competition, compress margins but broaden access. Innovation in drug delivery, notably transdermal systems and implantable devices, will drive premium pricing segments.

Risks and Opportunities

Risks:

• Safety concerns linked to hormone therapy, especially related to cancer and cardiovascular risks, impact prescribing patterns.
• Patent cliffs threaten exclusivity and revenue streams for branded products.
• Regulatory delays or reclassifications could hinder faster market access.

Opportunities:

• Development of long-acting, targeted delivery systems.
• Expansion into emerging markets with lower price points.
• New indications such as bioidentical hormone therapy for non-menopausal women.

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Key Takeaways

• Aging demographics and increased menopausal awareness sustain demand.
• Biosimilar competition is rising, exerting downward pressure.
• Product innovation in delivery methods offers premium pricing potential.
• Regulatory trends favor approved, standardized formulations over compounded compounds.
• The market will continue to grow cumulatively at approximately 4-5% annually until 2030.

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FAQs

Q1: How will biosimilar entry affect estradiol and progesterone revenues?
A: Biosimilars will increase volume sales, reduce prices, and intensify competition, but revenues will stabilize through market expansion and differentiated formulations.

Q2: What are the primary markets driving growth?
A: The United States, Europe, and emerging economies such as China and India show robust growth due to aging populations and contraceptive demand.

Q3: What delivery methods are most promising?
A: Transdermal patches, gels, and subcutaneous implants aim to improve compliance and targeting while commanding premium pricing.

Q4: How do safety concerns impact market growth?
A: Safety issues, especially regarding cancer risk, lead to conservative prescribing, though approved formulations with rigorous safety profiles maintain market stability.

Q5: Will the market see significant consolidation?
A: Yes; patent expirations and biosimilar introduction favor mergers and acquisitions, creating larger entities with diversified portfolios.

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References

1. MarketWatch. (2023). Hormone Therapy Market Size & Trends.
2. Grand View Research. (2022). Hormonal Therapy Market Analysis.
3. FDA. (2022). Hormone Therapy: Regulatory Updates.
4. European Medicines Agency (EMA). (2022). Biosimilar Regulations.
5. Bloomberg Intelligence. (2023). Pharmaceutical Market Forecasts.

[1] MarketWatch, "Hormone Therapy Market Size & Trends," 2023.
[2] Grand View Research, "Hormonal Therapy Market Analysis," 2022.
[3] FDA, "Regulatory Updates on Hormone Therapy," 2022.
[4] EMA, "Biosimilar Regulations," 2022.
[5] Bloomberg Intelligence, "Pharmaceutical Market Forecasts," 2023.