DROSPIRENONE; ETHINYL ESTRADIOL - Generic Drug Details

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

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Jubilant Cadista, Pharmobedient, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Bayer Hlthcare, Apotex, Dr Reddys Labs Sa, Naari Pte, and Watson Labs Inc, and is included in thirty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for DROSPIRENONE; ETHINYL ESTRADIOL

US Patents:	2
Tradenames:	16
Applicants:	16
NDAs:	33
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	43
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DROSPIRENONE; ETHINYL ESTRADIOL
DailyMed Link:	DROSPIRENONE; ETHINYL ESTRADIOL at DailyMed

Recent Clinical Trials for DROSPIRENONE; ETHINYL 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; ETHINYL ESTRADIOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ETHINYL 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; ETHINYL ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YAZ	Tablets	drospirenone; ethinyl estradiol	3 mg/0.02 mg	021676	1	2006-09-29
YASMIN	Tablets	drospirenone; ethinyl estradiol	3 mg/0.03 mg	021098	1	2005-01-07

US Patents and Regulatory Information for DROSPIRENONE; ETHINYL ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	NIKKI	drospirenone; ethinyl estradiol	TABLET;ORAL	201661-001	May 27, 2014	AB	RX	No	No
Glenmark Pharms Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	204848-001	Mar 25, 2016	AB	RX	No	No
Hetero Labs	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	213034-001	Jan 24, 2020	AB	RX	No	No
Watson Labs Inc	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	203594-001	Oct 11, 2016	AB	RX	No	No
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	AB	RX	Yes	Yes
Watson Labs Inc	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	203593-001	Oct 11, 2016	AB	RX	No	No

Expired US Patents for DROSPIRENONE; ETHINYL ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006

Market Dynamics and Financial Trajectory for Drospirenone; Ethinyl Estradiol

Last updated: July 29, 2025

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Introduction

The combination of drospirenone and ethinyl estradiol (EE) constitutes a highly prominent formulation used primarily for oral contraceptives, with additional applications in hormone replacement therapy (HRT) and treatment of certain dermatological conditions. As global demand for contraceptive solutions and hormone therapies surges, understanding the market dynamics and financial trajectory for this drug combination becomes critically important for stakeholders, including pharmaceutical companies, investors, healthcare providers, and regulatory agencies.

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Pharmacological Profile and Indications

Drospirenone is a synthetic progestin with antimineralocorticoid properties, offering hormonal balance by counteracting water retention and premenstrual symptoms. Ethinyl estradiol is a synthetic estrogen, potent and widely used in contraceptive formulations. Together, these components produce a combined oral contraceptive (COC) with high efficacy, a favorable safety profile, and additional benefits like reduced acne and regulation of menstrual cycles.

The primary indication remains preventing pregnancy, but secondary uses include management of hormonal imbalances, acne vulgaris treatment, and select hormonal therapies in women with menopausal symptoms.

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Market Landscape and Historical Trends

Global Market Size and Growth Trends

The global market for combined oral contraceptives (COCs), predominantly containing drospirenone/EE, was valued at approximately USD 4.5 billion in 2021 and is projected to reach around USD 6.2 billion by 2030, growing at a compound annual growth rate (CAGR) of 4-5% [1].

Key regions contributing to growth include North America, Europe, and Asia Pacific. The North American market dominates due to high contraceptive awareness, product availability, and a sizeable target demographic of reproductive-age women. Asia Pacific exhibits rapid expansion driven by increasing healthcare affordability and product accessibility.

Drivers of Market Growth

• Rising global contraceptive awareness and acceptance: Societal shifts towards family planning increase demand.
• Innovative product launches: New formulations with improved safety profiles stimulate market expansion.
• Broader applications: Use in hormonal regulation, acne, and HRT widens the application spectrum.
• Regulatory approvals facilitating expansion: Regulatory pathways streamline entry of new formulations, especially biosimilars and generics.

Challenges and Restraints

• Regulatory hurdles and safety concerns: Warnings related to thromboembolic risks associated with EE-containing contraceptives have impacted prescribing practices.
• Competing alternatives: Non-hormonal and long-acting reversible contraceptives (LARCs) such as IUDs and implants reduce reliance on oral pills.
• Pricing pressures and patent expiries: Generic proliferation affects revenue streams for branded products.

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Competitive Landscape

Major players include Bayer AG, Teva Pharmaceutical Industries, Mylan (now part of Viatris), Pfizer, and Sandoz. Bayer’s Yaz and Yasmin products are prominent market brands. Patent expirations and the entry of generic equivalents have intensified price competition, influencing profit margins.

Bayer dominates with a substantial market share due to its established portfolio and extensive distribution channels. However, biosimilars and generics threaten to erode revenues, especially in regions with strong patent enforcement and healthcare reimbursement policies.

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Regulatory and Reimbursement Environment

Regulatory agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) impose rigorous safety and efficacy standards. Post-market surveillance and ongoing safety advisories influence market dynamics, often leading to formulation modifications or label updates.

Reimbursement policies significantly impact sales, especially in the U.S. and Europe. Insurance coverage enhances access, while restrictive policies can impede growth.

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Financial Trajectory and Revenue Drivers

Revenue Projections and Profitability

The financial success of drospirenone/EE products hinges on sales volumes, pricing strategies, and patent protections. Patents generally provide exclusivity periods of 10–15 years; however, numerous formulations have faced patent challenges, leading to generic competition.

In regions like North America, branded formulations generate premium pricing, supporting higher margins. Globally, the expansion into emerging markets and the introduction of cost-effective generics have driven revenue growth.

Impact of Patent Expirations

Patent expiries, most notably around the mid-2020s, are expected to decelerate revenue growth due to increased generic competition. Companies that have already diversified their portfolios with biosimilars or alternative contraceptive methods are better positioned to maintain stability.

Innovation and Line Extensions

Recent innovations include improved formulations with reduced hormone doses and novel delivery mechanisms (e.g., patches, vaginal rings). These product line extensions can foster incremental revenue streams and extend market presence.

Cost Factors and Profit Margins

Manufacturing costs are relatively stable but are affected by raw material prices, regulatory compliance costs, and distribution logistics. Companies with vertical integration and robust supply chains maintain higher profit margins.

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Emerging Trends and Future Outlook

• Shift towards contraceptive biosimilars: Patent expirations open opportunities for biosimilars, reducing prices and expanding access.
• Digital health integration: Mobile apps and adherence tracking improve compliance and repeat prescriptions, stimulating sales.
• Focus on safety profiles: Innovations aimed at reducing thromboembolic risks may rejuvenate market interest.
• Market consolidation: Mergers and acquisitions may recalibrate competitive dynamics, offering economies of scale and broader distribution channels.

Long-Term Outlook

The outlook remains cautiously optimistic. While growth may moderate due to market saturation and safety concerns, ongoing innovation, expanding markets, and increasing acceptance bolster revenue prospects. The strategic focus for pharmaceutical companies involves balancing innovation with cost management and regulatory navigation.

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Key Takeaways

• The drospirenone/ethinyl estradiol market is poised for steady growth, driven by rising contraceptive demand and expanding indications.
• Patent expirations and generics are central to future revenue trajectories, contributing to pricing pressures but also broadening access.
• Innovation in formulation, delivery, and safety profiles will be critical to maintaining market share.
• Regulatory, reimbursement, and safety considerations significantly influence market dynamics.
• Strategic diversification and investments in biosimilars or alternative delivery systems are vital for long-term profitability amid competitive pressures.

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FAQs

1. How have recent safety concerns affected the market for drospirenone/ethinyl estradiol?
Safety advisories, especially regarding thrombotic risks associated with EE-containing contraceptives, have led to cautious prescribing and formulation modifications. This has slightly impacted sales but spurred innovations aimed at improving safety profiles.

2. What regions are most promising for growth in this market?
Emerging markets in Asia Pacific and Latin America hold significant growth potential due to increasing healthcare access and rising contraceptive awareness, complementing mature markets in North America and Europe.

3. How does patent expiration influence revenue for pharmaceutical companies?
Patent expiry opens the market to generics, typically reducing proprietary product sales by 60–80%. Companies mitigate this through innovation, portfolio diversification, and cost efficiencies.

4. Are biosimilars expected to impact the drospirenone/EE market?
While biosimilars are more common in biologics, generic formulations of drospirenone/EE already contribute to competitive pricing, and further biosimilar entries could continue this trend, lowering prices and expanding access.

5. What innovations are anticipated to sustain the market?
Innovations include lower-dose formulations, alternative delivery routes (patches, rings), and improved safety profiles, all aimed at enhancing efficacy, safety, and adherence.

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References

[1] Market Research Future. (2022). Global Contraceptive Market Report.