Drospirenone; ethinyl estradiol; levomefolate calcium - Generic Drug Details

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

Drospirenone; ethinyl estradiol; levomefolate calcium is the generic ingredient in four branded drugs marketed by Bayer Hlthcare, Lupin Ltd, and Watson Labs Inc, and is included in six NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for drospirenone; ethinyl estradiol; levomefolate calcium

US Patents:	2
Tradenames:	4
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for drospirenone; ethinyl estradiol; levomefolate calcium
DailyMed Link:	drospirenone; ethinyl estradiol; levomefolate calcium at DailyMed

Recent Clinical Trials for drospirenone; ethinyl estradiol; levomefolate calcium

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

Sponsor	Phase
Bayer	Phase 3

See all drospirenone; ethinyl estradiol; levomefolate calcium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for drospirenone; ethinyl estradiol; levomefolate calcium

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; LEVOMEFOLATE CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BEYAZ	Tablets	drospirenone; ethinyl estradiol; levomefolate calcium	3 mg/0.02 mg/ 0.451 mg and 0.451 mg	022532	1	2012-11-13
SAFYRAL	Tablets	drospirenone; ethinyl estradiol; levomefolate calcium	3 mg/0.03 mg/ 0.451 mg and 0.451 mg	022574	1	2012-09-28

US Patents and Regulatory Information for drospirenone; ethinyl estradiol; levomefolate calcium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	TYDEMY	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205948-001	Dec 12, 2017	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
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
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes			Y
Lupin Ltd	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947-001	Jun 13, 2018	AB	RX	No	No
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes			Y

Expired US Patents for drospirenone; ethinyl estradiol; levomefolate calcium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010

Market Dynamics and Financial Trajectory for Drospirenone; Ethinyl Estradiol; Levomefolate Calcium

Last updated: September 25, 2025

Introduction

The pharmaceutical landscape for combined hormonal contraceptives and folate supplementation is evolving rapidly due to shifting regulatory landscapes, demographic trends, and technological advancements. Among the notable compounds in this sector are drospirenone, ethinyl estradiol, and levomefolate calcium, which are pivotal in oral contraceptives and folate deficiency management. This analysis delineates the market dynamics and forecasted financial trajectory of these drugs, emphasizing evolving trends, competitive positioning, and growth opportunities.

Overview of the Drugs and Their Indications

Drospirenone: A progestin with antimineralocorticoid properties, primarily used in combined oral contraceptives (COCs) and hormone therapy. Its unique profile offers benefits such as reduced weight gain and lower edema risk, compared to other progestins.

Ethinyl Estradiol (EE): A synthetic estrogen, a mainstay component in COCs, serving as a regulator of the menstrual cycle and contraceptive agent. Its combination with progestins like drospirenone enhances contraceptive efficacy.

Levomefolate Calcium: An active form of folate used in the prevention of neural tube defects in pregnancy, and increasingly as a supplement for folate deficiency. Its stability and bioavailability offer advantages over folic acid in certain patient populations.

Market Dynamics

Regulatory Environment and Approval Trends

Recent regulatory shifts have significantly impacted market dynamics. Agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have refined guidelines for hormonal contraceptives and folate drugs, emphasizing safety profiles, especially pertaining to thromboembolic risks linked with estrogen components like ethinyl estradiol. These measures influence market entry and product approvals, with a preference toward drugs demonstrating improved safety margins.

Regulatory approval of generic formulations has increased price competition, especially in mature markets. The entry of biosimilars and generics dilutes revenue streams of branded products, prompting innovation in formulation and delivery methods.

Demographic and Epidemiological Trends

The global population of women of reproductive age is expanding, notably in emerging markets, which sustains demand for contraceptive options. The increasing awareness of folate’s role in prenatal care fuels growth in levomefolate calcium use, especially as regulatory bodies like the WHO advocate for folate supplementation to reduce neural tube defects.

Ageing populations in developed countries create opportunities in hormone replacement therapies, where drospirenone's antimineralocorticoid effects may have expanded indications.

Competitive Landscape

Major pharmaceutical players such as Bayer, Teva, and Mylan dominate the combined oral contraceptive segment with established products containing ethinyl estradiol and drospirenone. New entrants focus on differentiating through improved safety profiles, novel delivery systems, and integrated wellness packages.

In the folate segment, competition is intensifying with multiple formulations of levomefolate calcium, compounded by ongoing research into personalized supplementation strategies based on genetic profiles and metabolic markers.

Technological and Formulation Innovations

Advancements in drug delivery systems, such as transdermal patches, long-acting injectables, and multipurpose pills, are poised to reshape the contraceptive landscape. For levomefolate calcium, nanoparticle-based delivery and combination formulations are emerging trends to improve bioavailability and compliance.

Intellectual Property and Patent Landscape

Patents for key formulations of drospirenone and ethinyl estradiol are approaching expiration in key markets, fostering generic competition but also prompting developers to innovate around formulation patents, dosage, and combination therapies to prolong market exclusivity.

Market Challenges

Hesitance around hormonal contraceptives owing to safety concerns related to thromboembolic events presents hurdles, compelling companies to invest in safety evidence. Additionally, supply chain disruptions, especially for active pharmaceutical ingredients (APIs), have temporarily hampered production and pricing.

Financial Trajectory and Forecasting

Market Size and Growth Projections

The global oral contraceptives market was valued at approximately US$ 5 billion in 2022 and is projected to expand at a Compound Annual Growth Rate (CAGR) of 5-7% over the next five years, driven predominantly by emerging markets and product innovation.

Folate supplementation market is witnessing a CAGR of around 6-8% in response to increasing prenatal care initiatives and folate awareness campaigns, with levomefolate calcium's share expected to grow due to its superior bioavailability.

Key Revenue Drivers

• Product Innovation: Launch of next-generation formulations with improved safety and compliance benefits.
• Market Expansion: Penetration into underserved regions, governments’ subsidies, and public health programs.
• Regulatory Approvals: Clearance of biosimilars and generic alternatives that decrease costs and increase access.

Regional Outlook

• North America: Mature but stable, with pricing pressure due to patent expirations and high generic penetration.
• Europe: Regulatory tightening influences product availability; however, health awareness supports steady growth.
• Asia-Pacific: Fastest-growing segment, driven by a burgeoning female population, increasing healthcare infrastructure, and aggressive marketing.

Profitability Forecasts

Branded drug revenues for drospirenone and ethinyl estradiol are under downward pressure owing to patent cliffs but can be offset via lifecycle management strategies and line extensions. Levomefolate calcium, being a newer entrant, exhibits higher margins as adoption increases. Overall, companies investing in differentiated formulations are positioned to sustain profitability margins above industry averages.

Strategic Opportunities and Outlook

• Personalized Medicine: Integrating genetic testing to optimize folate supplementation regimens.
• Digital Health Integration: Leveraging mobile health applications for adherence monitoring, especially for contraceptive users.
• Partnerships and Collaborations: Strategic alliances between branded manufacturers and generic producers to expand market penetration and share risk.

Key Takeaways

• The market for drospirenone and ethinyl estradiol-based contraceptives remains robust, with growth driven by demographic trends and innovative delivery methods.
• Levomefolate calcium’s expanding role in prenatal care and folate deficiency management catalyzes its market expansion, propelled by increased healthcare awareness and regulatory support.
• Patent expirations and regulatory shifts heighten competition, emphasizing the importance of innovation, formulation differentiation, and market adaptation.
• Emerging markets offer substantial growth potential due to demographic dynamics and rising healthcare investments.
• Companies that prioritize safety, personalized approaches, and digital integration will better position financial health amid a competitive landscape.

FAQs

1. What are the primary factors influencing the market growth of drospirenone-containing contraceptives?
   Safety profiles, regulatory approvals, innovation in delivery systems, and demographic trends in women of reproductive age primarily drive growth.

2. How does levomefolate calcium compare to folic acid in clinical efficacy?
   Levomefolate calcium is biologically active, offering improved bioavailability and reduced reliance on enzymatic activation, making it more effective in certain genetic populations.

3. What impact do patent expirations have on the global contraceptive market?
   Patent expirations facilitate generic competition, reducing prices and expanding access but pressure revenues for branded manufacturers.

4. Are there emerging markets with significant growth potential for these drugs?
   Yes, Asia-Pacific and Latin America are experiencing rapid growth driven by increasing healthcare infrastructure, awareness, and favorable demographics.

5. What role does personalized medicine play in future folate supplementation strategies?
   Personalized strategies based on genetic testing can optimize folate dosing, improve outcomes, and align with regulatory shifts favoring individualized healthcare.

References

1. [1] Market Research Future. "Global Hormonal Contraceptives Market Report," 2022.
2. [2] WHO. "Folic Acid and Folate Supplementation," 2021.
3. [3] U.S. FDA. "Regulatory Considerations for Combination Hormonal Contraceptives," 2020.
4. [4] Allied Market Research. "Folate Supplements Market Analysis," 2022.
5. [5] IMS Health Data. "Pharmaceutical Market Trends," 2022.