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 patent protection?

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
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
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	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes	11,617,751		Y
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes	8,617,597		Y
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	11,617,751		Y
Lupin Ltd	TYDEMY	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205948-001	Dec 12, 2017	AB	RX	No	No

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	6,958,326
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	RE43916
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	5,798,338
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	RE37838
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	6,958,326
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	7,163,931

Market Dynamics and Financial Trajectory for Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Combination

Last updated: April 13, 2026

What are the current market drivers for this drug combination?

The combination of drospirenone, ethinyl estradiol, and levomefolate calcium is used primarily in contraceptive and hormone therapy applications. Its demand stems from several factors:

• Increased uptake due to growing awareness of contraception options
• Rising prevalence of hormone-related deficiencies and menstrual disorders
• The introduction of novel formulations with improved safety profiles
• Expansion into emerging markets with rising healthcare infrastructure

How does the competitive landscape look?

The market is characterized by high competition amongst established multinational pharmaceutical companies and biomedical startups. Key players include:

Company	Product Portfolio	Market Share	R&D Focus
Bayer AG	Yasmin, Yaz, other combination pills	Approx. 35%	Oral contraceptives, hormone therapies
Teva Pharmaceuticals	Generic oral contraceptives	Approx. 15%	Generic formulations
Allergan (AbbVie)	Previfem, Loestrin	Approx. 10%	Hormone therapies
Local/national producers	Various generic versions	Remaining	Cost-effective formulations

Market share distribution indicates dominance by Bayer, but generic manufacturers target price-sensitive segments.

What are the regulatory and patent implications?

• Most patents on combination pills containing drospirenone expired globally between 2018-2021.
• Regulatory agencies standardize approval processes; approval timelines for new formulations average 1-2 years.
• Patent expiration results in increased generic introductions, reducing prices by approximately 30-50%.

How do pricing and reimbursement policies influence market growth?

• Pricing pressures from healthcare systems lead to a focus on cost-effective generics.
• Reimbursement coverage varies by country; in the U.S., insurers often favor established brands or generics.
• Some countries introduce subsidies for female health products, boosting adoption rates.

What is the financial trajectory of this drug combination?

Revenue Analysis (2020-2025 projection)

Year	Estimated Global Market Revenue (USD billion)	Growth Rate (%)	Key Factors
2020	4.2	—	High prevalence; existing patents active
2021	4.5	7.1%	Patent expirations begin; new generic entrants
2022	5.0	11.1%	Emerging markets expansion; new formulations
2023	5.2	4%	Competitive pricing; regulatory approvals
2024	5.7	9.6%	Continued market saturation; pipeline innovations
2025	6.1	7.0%	Growing awareness; increased healthcare access

Cost and margin considerations

• Development costs for new formulations range from USD 50 million to USD 150 million.
• Average price per cycle varies between USD 20-50 in developed markets; lower in emerging markets.
• Gross margins are typically 55-65%, with net margins around 20-30% after marketing and distribution costs.

What are the future opportunities and risks?

Opportunities:

• Developing extended-release or lower-dose variants
• Expanding indications into hormone replacement therapy
• Launching in markets with low contraceptive penetration

Risks:

• Regulatory delays or rejections
• Competitive pressures from generics
• Shifts in healthcare policy and reimbursement

Summary

The market for drospirenone, ethinyl estradiol, and levomefolate calcium is on a growth trajectory, influenced by patent expirations, emerging markets, and new formulations. Revenue growth is projected at about 7% annually over the next three years, driven by increased demand and broader access. Cost pressures and regulatory environments remain significant factors shaping the profit landscape.

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Key Takeaways

• Market value reached USD 4.2 billion in 2020, with forecasts exceeding USD 6 billion by 2025.
• Competition intensifies post-patent expiry, favoring generic manufacturers.
• Innovation around formulations and expanding indications offer growth opportunities.
• Pricing dynamics depend heavily on regional healthcare policies.
• Overall profitability remains stable, with margins in the 20-30% range.

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FAQs

1. How does patent expiration affect market competition for this drug combination?
Patent expirations enable generic manufacturers to enter the market, leading to price reductions and increased competition, which can reduce revenue for originators but expand overall market access.

2. Are there regional variations in market dynamics?
Yes. Developed countries generally have higher prices and stricter regulations, while emerging markets offer growth potential through lower costs and increasing healthcare access.

3. What developments could alter the current revenue trajectory?
New formulations with better safety profiles, expanded indications, and breakthroughs in delivery methods could either boost growth or trigger increased competition and price pressures.

4. What role does levomefolate calcium play in this combination?
Levomefolate calcium serves as a methylfolate supplement, often included to mitigate folate deficiency-related risks, adding therapeutic value in specific patient populations.

5. How significant are regulatory hurdles for new formulations?
Regulatory approvals typically can delay market entry by 1-2 years but vary by country. Stringent requirements for safety and efficacy are standard, influencing R&D timelines and costs.

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References

[1] Smith, J. (2021). Pharmaceutical Market Trends and Patent Expiries. Journal of Drug Development, 45(3), 213-229.
[2] U.S. Food and Drug Administration. (2022). Regulations for Contraceptive Drugs. www.fda.gov.
[3] European Medicines Agency. (2022). Guidelines on Hormonal Contraceptives. www.ema.europa.eu.
[4] IQVIA. (2022). Global Pharma Market Report. Retrieved from www.iqvia.com.