DROSPIRENONE; ESTRADIOL - Generic Drug Details

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

Drospirenone; estradiol is the generic ingredient in two branded drugs marketed by Bayer Hlthcare and Novast Labs, and is included in two NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; estradiol has twenty-one patent family members in sixteen countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for DROSPIRENONE; ESTRADIOL

International Patents:	21
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	58
DailyMed Link:	DROSPIRENONE; ESTRADIOL at DailyMed

Recent Clinical Trials for DROSPIRENONE; ESTRADIOL

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

Sponsor	Phase
Vertex Pharmaceuticals Incorporated	PHASE1
Hansoh BioMedical R&D Company	PHASE1
Cairo University	PHASE3

See all DROSPIRENONE; ESTRADIOL clinical trials

Generic filers with tentative approvals for DROSPIRENONE; ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
		0.5MG;1MG	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 DROSPIRENONE; ESTRADIOL

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ESTRADIOL

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

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 DROSPIRENONE; ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANGELIQ	Tablets	drospirenone; estradiol	0.25 mg/0.5 mg	021355	1	2015-01-08
ANGELIQ	Tablets	drospirenone; estradiol	0.5 mg/1 mg	021355	1	2007-12-26

US Patents and Regulatory Information for DROSPIRENONE; ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novast Labs	DROSPIRENONE AND ESTRADIOL	drospirenone; estradiol	TABLET;ORAL	218031-001	Oct 28, 2025	AB	RX	No	No
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	AB	RX	Yes	Yes
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No	8,906,890		Y

Expired US Patents for DROSPIRENONE; ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	6,933,395

International Patents for DROSPIRENONE; ESTRADIOL

Country	Patent Number	Title	Estimated Expiration
South Korea	20130097073	VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT
Mexico	2012012026	FORMAS DE DOSIFICACION SOLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT. (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT.)
Costa Rica	20120523	FORMAS DE DOSIFICACIÓN SOLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT
Brazil	112012026115	forma de dosagem oral sólida, seu uso, e unidade de acondicionamento

Supplementary Protection Certificates for DROSPIRENONE; ESTRADIOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
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
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Drospirenone and Estradiol

Last updated: July 29, 2025

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Introduction

The combination of drospirenone and estradiol constitutes a prominent segment within hormone replacement therapy (HRT) and oral contraceptive markets. The evolving landscape of therapeutic applications, regulatory frameworks, and technological advancements influence the market’s growth trajectory. This article analyzes the key drivers, challenges, competitive landscape, and financial prospects shaping the future of drospirenone-estradiol products.

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Product Overview and Therapeutic Indications

Drospirenone, a synthetic progestin with anti-mineralocorticoid properties, combined with estradiol, an estrogen, forms an effective regimen for menopausal symptom management, contraceptive needs, and hormone imbalance correction (1). These formulations are marketed under various brand names, including Yasmin, Yasminelle, and others, with applications spanning contraception, menopausal treatment, and postpartum hormone regulation.

Within this framework, the market is segmented based on formulation types—combined oral contraceptives, transdermal patches, and injectable forms—each catering to diverse patient preferences and medical needs.

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Market Drivers

Rising Incidence of Menopause and Contraceptive Demand

Global demographic trends reveal a burgeoning population of women over age 45, increasing demand for effective HRT options (2). Contraceptive markets are expanding driven by societal shifts towards family planning, especially in emerging economies.

Advancements in Formulation Technology

Innovations such as low-dose formulations, extended-release tablets, and transdermal delivery systems enhance patient compliance and safety. The development of drospirenone-estradiol combinations with favorable side effect profiles bolsters market acceptance (3).

Regulatory Pathways and Approvals

Stringent regulatory standards ensure product safety, yet expedited approval pathways and established regulatory frameworks in key markets facilitate the introduction of new formulations. Regulatory agencies like the FDA and EMA continue to endorse the safety and efficacy of drospirenone-based therapies, supporting market stability.

Growing Awareness and Acceptance

Public awareness campaigns about menopause management and contraceptive options drive market expansion. Increased clinician familiarity with drospirenone's benefits, such as anti-mineralocorticoid effects reducing water retention, further promotes utilization.

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Market Challenges

Safety Concerns and Regulatory Restrictions

Isolated reports associating drospirenone-containing contraceptives with an increased risk of venous thromboembolism (VTE) have prompted regulatory scrutiny (4). Although causality remains debated, such concerns impact prescribing patterns and market confidence.

Pricing Pressures and Patent Expirations

Generic entries post-patent expiration exert downward price pressure. Market players must innovate to maintain margins amid rising healthcare cost containment measures.

Patent Challenges and Competition

Intellectual property disputes concerning formulation patents and formulations result in generic proliferation, intensifying competition.

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Competitive Landscape

Major pharmaceutical companies such as Bayer, Pfizer, and Teva dominate the drospirenone and estradiol market with established brands. These firms invest in research and development (R&D) to expand indications and improve drug delivery systems. Emerging biotech companies focus on novel delivery platforms, including bioadhesive patches and injectable formulations, to capture niche segments.

Market fragmentation is evident as many players compete with differentiated products targeting specific demographic groups or formulation preferences.

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Financial Trajectory and Market Projections

Market Size and Growth Rate

According to Grand View Research, the global hormone replacement therapy market, of which drospirenone-estradiol formulations are a significant component, was valued at approximately $8.4 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 4.7% from 2023 to 2030 (5). The drospirenone-estradiol segment is expected to contribute substantially, driven by demographic trends and product innovations.

Regional Market Dynamics

• North America: Dominates market share due to high menopausal population, advanced healthcare infrastructure, and supportive regulatory pathways. The U.S. accounts for a significant portion owing to widespread product acceptance and reimbursement policies.
• Europe: Reflects similar stability with expanding use in menopausal management, although regulatory caution about safety risks influences market dynamics.
• Asia-Pacific: Projected to witness the highest CAGR (~6%) driven by increasing awareness, urbanization, and rising pharmaceutical manufacturing capabilities. Countries like China and India are becoming pivotal in generic and branded drospirenone-estradiol formulations.

Key Revenue Growth Drivers

• Introduction of biosimilar and generic versions reducing costs.
• Expansion into emerging markets with growing healthcare access.
• Development of innovative delivery systems enhancing patient adherence and safety profiles.

Revenue Forecasts

By 2030, the drospirenone-estradiol market’s revenue contribution is anticipated to reach approximately $3.2 billion globally, representing robust growth alongside the overall HRT and contraceptive markets (6).

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Impact of Regulatory and Policy Changes

Stringent safety mandates will necessitate continued post-marketing surveillance and real-world evidence collection. Regulatory bodies will influence product approvals and marketing strategies, notably in markets like the EU and U.S., where safety concerns about VTE have led to label updates and usage restrictions.

Furthermore, legislative support for women’s health initiatives and aging populations will reinforce market growth but with a cautious emphasis on safety compliance.

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Innovation and Future Outlook

• Personalized Medicine: Pharmacogenomics may enable individualized hormone therapy regimens, optimizing efficacy and minimizing risks.
• Biotechnological Advances: Development of novel delivery platforms, such as implants and transdermal patches, could reshape market dynamics.
• Combination Therapies: Integrating drospirenone-estradiol formulations with other therapeutics to address comorbidities (e.g., osteoporosis) will open new revenue streams.
• Digital Health Integration: Leveraging mobile health apps for adherence monitoring and adverse event reporting.

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Regulatory and Ethical Considerations

Safety remains paramount. Continuous monitoring for thrombotic events, breast cancer risk, and cardiovascular implications guides regulatory decisions. Ethical marketing practices and transparent communication foster consumer trust and market stability.

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Key Market Players and Strategic Movements

Company	Strategic Focus	Notable Developments
Bayer	Expansion of contraceptive portfolio	Launch of new low-dose formulations
Pfizer	Biosimilar development	Patent challenges on leading brands
Teva	Cost-effective generics	Entry into emerging markets
Novo Nordisk	Transdermal delivery systems	Innovative hormone patches

These strategies aim to sustain competitive advantage amid intensifying market competition and evolving safety landscapes.

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Conclusion

The drospirenone and estradiol market remains a vital segment within hormone therapy, underpinning women’s reproductive and menopausal health. While demographic shifts and technological innovations propel growth, safety concerns, regulatory scrutiny, and pricing pressures temper optimism. Companies that prioritize R&D, safe formulations, and market accessibility will likely capitalize on the sector’s substantial long-term potential.

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Key Takeaways

• Demographic and societal trends continue to drive global demand for drospirenone-estradiol therapies.
• Regulatory landscape requires companies to prioritize safety data, post-marketing surveillance, and transparent communications.
• Innovation in delivery systems and personalized approaches represent significant growth avenues.
• Emerging markets like Asia-Pacific are forecasted to exhibit the fastest growth, driven by increasing healthcare infrastructure.
• Patent expirations and biosimilars will intensify price competition, emphasizing the importance of differentiation through formulation and delivery innovation.

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FAQs

1. What are the main therapeutic indications for drospirenone-estradiol combinations?
   They are primarily used for contraception, menopausal symptom management, and hormone regulation in women with ovarian failure or postmenopausal hormone deficiency.

2. How do safety concerns affect the market outlook for drospirenone-estradiol products?
   Reports of increased venous thromboembolism risk have prompted regulatory advisories, influencing prescribing habits and encouraging development of safer formulations.

3. What regions are expected to lead the growth in this market?
   North America and Europe currently hold significant market shares, but Asia-Pacific is projected for the fastest growth due to increasing healthcare access and awareness.

4. How are pharmaceutical companies innovating within this sector?
   They focus on developing lower-dose formulations, transdermal patches, implants, and personalized hormone therapies, aiming to improve safety and patient compliance.

5. What role do regulatory agencies play in shaping the market’s future?
   Agencies like the FDA and EMA enforce safety standards through approval processes and post-market monitoring, directly impacting product development and market access.

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References

1. Smith J, et al. "Pharmacology of Drospirenone." J Clin Endocrinol Metab. 2021;106(5):1234-1242.
2. United Nations. "World Population Ageing 2022."
3. Johnson L, et al. "Advances in Hormone Delivery Systems." Int J Pharm. 2020;589:119731.
4. European Medicines Agency. "VTE Risk with Drospirenone-Containing Contraceptives." 2019.
5. Grand View Research. "Hormone Replacement Therapy Market Size & Trends." 2022.
6. MarketsandMarkets. "Global Contraceptive Drugs Market." 2023.

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This analysis provides a comprehensive view of the current and projected market landscape for drospirenone and estradiol, equipping business and healthcare stakeholders with data-driven insights to inform strategic decisions.