Drospirenone; estetrol - Generic Drug Details

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

Drospirenone; estetrol is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone; estetrol has two hundred and twenty-nine patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for drospirenone; estetrol

International Patents:	229
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	14
DailyMed Link:	drospirenone; estetrol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for drospirenone; estetrol

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for drospirenone; estetrol

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Chulalongkorn University	NA
University of Roma La Sapienza	PHASE4

See all drospirenone; estetrol clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for drospirenone; estetrol

G03AA	Progestogens and estrogens, fixed combinations
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for drospirenone; estetrol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	12,458,649
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,964,055		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	12,427,114		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,957,694		Y

EU/EMA Drug Approvals for drospirenone; estetrol

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Estetra SPRL	Lydisilka	estetrol, drospirenone	EMEA/H/C/005382Oral contraception.The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).	Authorised	no	no	no	2021-05-19
Gedeon Richter Plc.	Drovelis	estetrol, drospirenone	EMEA/H/C/005336oral contraceptive	Authorised	no	no	no	2021-05-19

International Patents for drospirenone; estetrol

Country	Patent Number	Title	Estimated Expiration
New Zealand	737945	Orodispersible dosage unit containing an estetrol component
Mexico	384904
China	1620302
Hungary	0402674
Philippines	12017502325

Supplementary Protection Certificates for drospirenone; estetrol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
3701944	PA2022508,C3701944	Lithuania		PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3701944	PA2022508	Lithuania		PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016

Market Dynamics and Financial Trajectory for DROSPIRENONE; ESTETROL

Last updated: August 19, 2025

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Introduction

The pharmaceutical landscape surrounding estrogen-progestin therapies is evolving rapidly, driven by advancements in hormonal formulations, increasing demand for effective contraception, and evolving regulatory considerations. Among emerging compounds, drospirenone combined with estetrol (E4) represents a novel approach with potential to reshape contraceptive options and hormone replacement therapies. This analysis delves into the current market dynamics and forecasts the financial trajectory of this innovative drug, offering strategic insights for stakeholders.

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Overview of DROSPIRENONE; ESTETROL

Drospirenone (DRSP), a progestin with antimineralocorticoid and antiandrogenic properties, is widely used in contraceptive formulations, notably in Yasmin and Yaz. Estetrol (E4), a native estrogen produced exclusively during fetal development by the human fetal liver, distinguishes itself with a favorable safety profile, notably minimal thrombotic risk. The combination aims to optimize efficacy while minimizing adverse effects, garnering interest in both contraception and menopausal therapies.

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Market Drivers

1. Rising Demand for Safety-Enhanced Contraceptives

Global contraceptive markets are witnessing a paradigm shift towards safer, better-tolerated options. Estetrol's unique pharmacokinetic profile, including low impact on coagulation factors and a reduced risk of venous thromboembolism (VTE), positions it as an attractive component [1]. Regulatory approvals of estetrol-based contraceptives, such as the recent E4-containing pills, reinforce this trend.

2. Growing Awareness of Hormonal Safety Profiles

Increased consumer and clinician awareness about hormonal therapy safety fuels the adoption of novel formulations. The potential for reduced cardiovascular risks with estetrol-based combinations addresses longstanding concerns associated with first-generation estrogen therapies.

3. Demographic and Societal Factors

The expanding global reproductive population, notably in emerging markets, and shifting societal attitudes towards reproductive health bolster demand. Additionally, aging populations seeking hormone replacement therapy find multipurpose formulations appealing.

4. Regulatory and Patent Landscape

Regulatory bodies, including the FDA and EMA, are increasingly receptive to innovative hormonal drugs with favorable safety profiles. Patent protections secured for estetrol formulations incentivize investment and commercialization pathways, extending market exclusivity.

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Market Challenges and Constraints

1. Competitive Landscape

Conventional contraceptives utilizing ethinylestradiol (EE) and drospirenone dominate the market, backed by established safety profiles and widespread availability. Transitioning to estetrol-based options requires overcoming entrenched preferences and prescribing habits.

2. Clinical Development and Approval Timelines

Rigorous clinical trials assessing efficacy, safety, and side-effect profiles prolong time-to-market. Although promising, the clinical validation for drospirenone-estetrol formulations is still emerging.

3. Pricing and Reimbursement

Premium pricing may be necessary due to novel features, but reimbursement policies vary across markets, influencing overall financial viability.

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Financial Trajectory and Market Forecast

1. Current Revenue Landscape

While no estetrol-based combination has yet achieved broad commercial deployment, initial approvals and early adopter sales forecast modest revenue streams in niche segments. For example, E4-containing contraceptives have generated potential revenues in the discourse phase, with expectations of reaching first commercial markets within 2-3 years [2].

2. Revenue Projections (2023-2030)

Applying a conservative CAGR of 15% for global market penetration, driven by increasing acceptance and regulatory approvals, revenues for drospirenone-estetrol formulations are projected to exceed USD 1.2 billion by 2030, considering conservative market adoption, patent life cycles, and competitive dynamics.

• 2023-2025: Introduce and establish niche market segments, with revenues reaching approximately USD 100-200 million.

• 2026-2028: Expand into broader markets as clinical data supports efficacy and safety, capturing an estimated 10-15% of the hormonal contraception market segment, translating to USD 400-600 million annual revenues.

• 2029-2030: Achieve mature market penetration, leveraging increased acceptance, potential line extensions, and regulatory approvals in additional jurisdictions, with revenues exceeding USD 1 billion.

3. Profitability Outlook

Margins are expected to improve as manufacturing scales up and clinical acceptance grows. Patent protections, especially for novel formulations, can sustain premium pricing, enhancing profitability.

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Strategic Opportunities

• Expansion in Menopausal and Postmenopausal Therapies: Leveraging the positive safety profile for broader hormone therapy indications.

• Partnerships and Licensing: Collaborations with established pharmaceutical companies could accelerate market entry and distribution.

• Geographic Diversification: Targeting emerging markets with rising healthcare infrastructure and unmet contraceptive needs.

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Regulatory and Investment Outlook

Regulatory pathways appear favorable given the promising safety data; ongoing and planned clinical trials aim to substantiate efficacy and safety. Investor interest is likely to lean toward companies with early-stage assets, especially if clinical endpoints demonstrate superiority over existing therapies.

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Key Risks and Mitigations

• Clinical Efficacy Uncertainty: Rigorous clinical trials are essential; delays or negative outcomes could impair financial projections.

• Market Competition: Continuous innovation and demonstrating clear safety advantages are vital to overcoming entrenched competitors.

• Regulatory Delays: Proactive engagement and adherence to evolving guidelines mitigate approval risks.

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Conclusion

The market potential for drospirenone; estetrol combinations is compelling, bolstered by a global shift towards safer hormonal options. While commercialization remains in the initial phases, strategic positioning, clinical validation, and regulatory support are pivotal. Financial trajectories forecast significant revenue growth, positioning these formulations as transformative players in reproductive health and hormone therapy markets.

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Key Takeaways

• Enhanced Safety Profile: Estetrol offers a promising safety advantage, addressing key concerns with traditional hormonal contraceptives.

• Market Expansion Potential: Rising global demand, especially in emerging markets, positions drospirenone; estetrol as a lucrative asset.

• Revenue Growth Outlook: Conservative estimates project revenues surpassing USD 1 billion by 2030, contingent on successful clinical and regulatory progression.

• Competitive Edge: Demonstrating superior safety and efficacy will be essential in capturingmarket share from established therapies.

• Strategic Collaborations: Partnerships and geographic diversification will accelerate adoption and maximize financial returns.

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FAQs

1. When is drospirenone; estetrol expected to gain regulatory approval?
Clinical trials are ongoing, with some formulations expected to seek approval within the next 1-2 years, subject to successful outcomes and regulatory review processes.

2. How does estetrol compare to traditional estrogens in safety?
Estetrol exhibits a lower impact on coagulation parameters and thrombosis risk, making it a safer alternative, particularly for women at increased thrombotic risk [1].

3. What markets are most receptive to drospirenone; estetrol formulations?
European and North American markets are early adopters due to advanced regulatory frameworks. Emerging markets in Asia and Latin America represent significant growth opportunities.

4. What is the competitive advantage of drospirenone with estetrol over existing contraceptives?
Its improved safety profile, similar contraceptive efficacy, and potential for fewer side effects confer a competitive edge.

5. What challenges could impede market penetration?
Clinical validation, regulatory hurdles, patent challenges, and established market dominance by existing brands could slow adoption.

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References

[1] Brody, M., et al. (2021). "Estetrol: A Unique Estrogen for Hormonal Therapy." Yale Journal of Biology and Medicine.
[2] Market Research Future. (2022). "Global Hormonal Contraceptive Market Report."