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-one patent family members in twenty-one countries.

Three suppliers are listed for this compound.

Summary for estradiol; progesterone

International Patents:	171
US Patents:	24
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	267
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 Wisconsin, Madison	Phase 2
Lauren Whitehurst	Phase 3
Ohio State University	Phase 3

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	10,052,386		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	8,633,178		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	9,301,920		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	9,114,146		Y
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	210132-001	Oct 28, 2018		RX	Yes	Yes	9,006,222		Y

International Patents for estradiol; progesterone

Country	Patent Number	Title	Estimated Expiration
Australia	2019204655	Natural Combination Hormone Replacement Formulations And Therapies
Argentina	127914	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS
Canada	2947767	FORMULATIONS D'HORMONES SUBSTITUTIVES COMBINEES NATURELLES ET TRAITEMENT HORMONAL SUBSTITUTIF (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Australia	2019204658	Vaginal Inserted Estradiol Pharmaceutical Compositions And Methods
Japan	2018199711
Mexico	365818

Supplementary Protection Certificates for estradiol; progesterone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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
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	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

Estradiol; progesterone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estradiol and Progesterone

Introduction

Estradiol and progesterone are crucial hormones used in various medical treatments, particularly in women's health. The market for these hormones is driven by several factors, including increasing health awareness, technological advancements, and the rising incidence of related health issues. Here, we will delve into the market dynamics and financial trajectory of these hormones.

Market Size and Growth

The global progesterone market, which often includes formulations with estradiol, is substantial and growing. As of 2024, the progesterone market size is estimated to be around USD 1.74 billion and is projected to reach USD 2.67 billion by 2029, growing at a CAGR of 8.92% during the forecast period[1][4].

Regional Market Performance

• North America: This region dominates the global progesterone market due to the high adaptability of advanced treatments, collaborative efforts among market players, and a significant disease burden. The U.S. has one of the largest and most developed pharmaceutical markets, driving demand for progesterone and estradiol formulations[1][4].
• Asia Pacific: This region is expected to be the fastest-growing market for progesterone, driven by increasing healthcare spending, growing awareness, and a large patient population[1].

Key Drivers of Market Growth

Increasing Incidence of Related Health Issues

• Breast Cancer: The rising incidence of breast cancer is a significant driver. According to IARC data, about 2.2 million new cases of breast cancer were reported worldwide in 2020, and this number is expected to reach 3 million by 2040. Progesterone is used in treating breast tenderness associated with breast cancer[1].
• Uterine Body Cancer: The increase in uterine body cancers, particularly in North America, also contributes to the market growth. In 2020, the American Cancer Society estimated 65,950 new cases of uterine body cancer in the United States[1].

Technological Advancements and Product Developments

• Drug Delivery Systems: Advances in drug delivery systems have improved the efficacy and patient compliance of progesterone and estradiol treatments. For instance, the FDA-approved oral softgel capsule Bijuva (TX-001HR) combines estradiol and progesterone, significantly reducing vasomotor symptoms without causing endometrial hyperplasia or cancer[5].
• New Product Launches: Companies like Besins Healthcare have launched new products, such as Utrozhestan (progesterone), which contribute to market growth[1].

Impact of COVID-19

• The COVID-19 pandemic had a positive impact on the progesterone market due to its potential in reducing the severity of COVID-19 in male patients. Clinical trials, such as the one conducted at Cedars-Sinai Medical Center, showed improved clinical outcomes for hospitalized men treated with progesterone, increasing demand during the pandemic[1].

Risks and Benefits

Clinical Outcomes

• Women's Health Initiative (WHI): The WHI study highlighted the risks and benefits of combined estrogen and progestin therapy. While it showed increased risks of coronary heart disease, strokes, and invasive breast cancer, it also indicated benefits such as reduced colorectal cancer and hip fractures. However, the overall health risks exceeded the benefits for primary prevention of chronic diseases[2].

Variability in Compounded Formulations

• Consistency Concerns: Studies have shown significant variability in estradiol and progesterone levels in compounded hormone therapy formulations, which can lead to risks due to inconsistent dosing. This underscores the need for FDA-approved bioidentical hormone therapies to ensure consistency and safety[3].

Market Players and Competitive Landscape

• Major Players: Companies such as Cadila Pharmaceuticals, Alkem Labs, Cipla Limited, Lupin Limited, and Glenmark Pharmaceuticals are key players in the progesterone market. These companies engage in collaborative efforts, product launches, and R&D to enhance their market presence[1].
• Collaborative Efforts: Market players are increasingly involved in collaborative agreements to enhance their R&D capabilities and meet the growing demand for progesterone and estradiol formulations[4].

Financial Projections

• CAGR and Market Size: The progesterone market is expected to grow at a CAGR of 8.92% from 2024 to 2029, reaching a market size of USD 2.67 billion by 2029. Another projection indicates a CAGR of 13.1% from 2024 to 2030, with the market size valued at USD 1.15 billion in 2023[1][4].

Key Takeaways

• The progesterone market, often combined with estradiol, is growing significantly due to increasing health issues like breast and uterine body cancers.
• Technological advancements and new product launches are driving market growth.
• The impact of COVID-19 has highlighted the potential benefits of progesterone in treating certain conditions.
• Regional markets, particularly North America and Asia Pacific, are key drivers of growth.
• Market players are focusing on R&D and collaborative efforts to meet the growing demand.

FAQs

What is the current market size of the progesterone market?

The progesterone market size is estimated to be USD 1.74 billion in 2024[1].

Which region is expected to dominate the progesterone market?

North America is expected to hold the largest market share in the progesterone market[1].

What are the key drivers of the progesterone market growth?

The key drivers include the rising incidence of breast and uterine body cancers, technological advancements in drug delivery systems, and increasing awareness among patients[1].

What are the risks associated with combined estrogen and progestin therapy?

Combined estrogen and progestin therapy is associated with increased risks of coronary heart disease, strokes, and invasive breast cancer, although it also has benefits such as reduced colorectal cancer and hip fractures[2].

Which companies are major players in the progesterone market?

Major players include Cadila Pharmaceuticals, Alkem Labs, Cipla Limited, Lupin Limited, and Glenmark Pharmaceuticals[1].

Sources

1. Mordor Intelligence: Progesterone Market - Growth, Report, Applications & Manufacturers.
2. JAMA Network: Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women.
3. PubMed: Determination of estradiol and progesterone content in capsules and creams.
4. Grand View Research: Progesterone Market Size, Share And Growth Report, 2030.
5. LWW Journals: Estradiol and progesterone bioavailability for moderate to severe vasomotor symptoms.