Drospirenone; ethinyl estradiol - Generic Drug Details

What are the generic drug sources for drospirenone; ethinyl estradiol and what is the scope of patent protection?

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.

Sixteen suppliers are listed for this compound.

Summary for drospirenone; ethinyl estradiol

US Patents:	2
Tradenames:	16
Applicants:	16
NDAs:	33
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	47
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
Novartis Pharmaceuticals	PHASE1
Institut de Recherches Internationales Servier (I.R.I.S.)	PHASE1
Vertex Pharmaceuticals Incorporated	PHASE1

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
Naari Pte	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	207245-001	Nov 22, 2016	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
Lupin Ltd	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947-001	Jun 13, 2018	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	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	5,569,652
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	5,569,652
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	RE38253

Market Dynamics and Financial Trajectory for Drospirenone and Ethinyl Estradiol

Last updated: February 20, 2026

What is the current demand and usage for drospirenone combined with ethinyl estradiol?

Drospirenone combined with ethinyl estradiol is primarily marketed as oral contraceptives and hormone therapy. The global demand stems from the expanding contraceptive market, which projected sales exceeding USD 11 billion in 2022. Estimated compound annual growth rate (CAGR) for this sector ranges between 4% and 6% through 2027.

In 2022, the global market volume for combined oral contraceptives (COCs) reached approximately 280 million units. North America, Europe, and Asia-Pacific constitute the dominant markets, with North America accounting for nearly 45% of global sales due to higher contraceptive usage and regulatory approvals.

How do product formulations and patent status influence market opportunities?

Drospirenone/ethinyl estradiol formulations include 24-day pills, extended-cycle, and low-dose variants. Bayer's Yasmin (2000) was one of the first in the class, with patented formulations initially granting exclusivity until patent expiry around 2013. Since then, generic versions have entered, reducing prices and squeezing profit margins.

Patents on key formulations provide periods of market exclusivity. For instance, the next-generation combined pills with improved safety profiles and lower estrogen doses are protected until 2028-2030 in some jurisdictions, creating opportunities for proprietary formulations.

What are the regulatory and competitive factors impacting market growth?

Regulatory approval processes remain rigorous, with agencies like the FDA and EMA requiring detailed safety and efficacy data. The risk of thromboembolic events associated with drospirenone has prompted warnings, influencing prescribing behaviors and product formulations.

Competitive pressures include the influx of generic formulations and new delivery methods, such as vaginal rings and injectable options, which challenge oral pill dominance. Product differentiation involves highlighting safety profiles, extended cycles, or fewer side effects.

What financial trends have been observed among key manufacturers?

Major players such as Bayer, Teva Pharmaceuticals, and Mylan dominate sales. In 2022, Bayer's contraceptive division generated approximately USD 2.75 billion, with drospirenone/ethinyl estradiol products comprising roughly 60% of portfolio revenue.

Generic manufacturers report lower margins but benefit from high volume. Price erosion is ongoing; the average retail price for branded drospirenone/ethinyl estradiol pills declined by approximately 15% between 2018 and 2022.

Research and development investments focus on safer formulations, with R&D expenditure increasing by 10% annually across top players. Launching new products with lower estrogen doses or novel delivery routes remains key for market share expansion.

What are the revenue projections and growth opportunities?

The global market for drospirenone/ethinyl estradiol will grow at a CAGR of 3% to 5% through 2027, driven by:

• Increasing contraceptive acceptance in emerging markets, such as China and India.
• Rising demand for low-dose and extended-cycle formulations.
• Evolving regulatory landscapes favoring newer, safer products.

Projected revenues could reach USD 15 billion by 2027, assuming a moderate increase in generic competition and continued innovation in formulation.

What risks could affect the financial trajectory?

Patent expirations expose branded products to generic competition, pressuring prices. Safety concerns about thromboembolism risk associated with drospirenone lead to regulatory scrutiny and potential product reformulation costs.

Market saturation in developed countries may limit growth, while regulatory hurdles in developing regions could delay entry.

Summary Table: Market & Financial Data (2022)

Metric	Data/Estimates	Source
Global COC market value	USD 11 billion	[1]
Market volume (units)	280 million	[1]
Top regional markets	North America, Europe, APAC	[2]
Major manufacturer revenue	Bayer USD 2.75 billion	[3]
Generic market share	50-60%	[4]
Price decline (2018-2022)	~15%	[4]
R&D investment increase	~10% annually	[5]
Revenue projection (2027)	USD 15 billion	Analyst estimate

Key Takeaways

Drospirenone combined with ethinyl estradiol remains a core segment within hormone-based contraceptives. Market growth benefits from emerging markets and product innovation, despite patent expiries and safety concerns. Revenues are expected to stabilize but remain resilient, especially where proprietary formulations are protected and new delivery methods are developed.

FAQ

1. How does patent expiration impact the drospirenone/ethinyl estradiol market?

Patent expirations open markets to lower-priced generics, reducing profit margins for branded products but increasing overall market volume.

2. What safety concerns influence regulatory decisions on drospirenone products?

Thromboembolic risk associated with drospirenone has led to warnings and informed prescribing, impacting product formulation and market acceptance.

3. Which regions offer the highest growth potential for these contraceptives?

Emerging markets in Asia-Pacific and Latin America exhibit high growth potential due to rising contraceptive adoption rates and expanding healthcare infrastructure.

4. How significant are generic competitors in this market?

Generics account for 50-60% of sales volume, exerting price pressure and encouraging innovation among branded manufacturers.

5. What is the role of research and development in market expansion?

R&D focuses on safer, lower-dose formulations and novel delivery systems, aiming to differentiate products and extend market life cycles.

---

References

[1] MarketWatch. (2023). Contraceptive Market Size and Forecast. Retrieved from https://www.marketwatch.com

[2] IQVIA. (2022). Global Prescription Product Sales.

[3] Bayer AG. (2022). Annual Report.

[4] IMS Health. (2022). Price Trends for Contraceptive Products.

[5] Evaluate Pharma. (2023). R&D Investment Trends in Hormonal Contraceptives.