DROSPIRENONE Drug Patent Profile

When do Drospirenone patents expire, and what generic alternatives are available?

Drospirenone is a drug marketed by Exeltis Usa Inc, Novast Labs, Barr, Glenmark Pharms Ltd, Hetero Labs, Jubilant Cadista, Pharmobedient, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Lupin Ltd, Naari Pte, and Watson Labs Inc. and is included in twenty-one NDAs. There are fifteen patents protecting this drug.

This drug has sixty-nine patent family members in thirty-one countries.

The generic ingredient in DROSPIRENONE is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Drospirenone

Annual sales in 2022 were $8mm indicating the motivation for generic entry (peak sales were $59mm in 2019).

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DROSPIRENONE

International Patents:	69
US Patents:	15
Applicants:	14
NDAs:	21
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DROSPIRENONE

Paragraph IV (Patent) Challenges for DROSPIRENONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SLYND	Tablets	drospirenone	4 mg	211367	1	2022-01-07

US Patents and Regulatory Information for DROSPIRENONE

DROSPIRENONE is protected by fifteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202131-001	May 4, 2015	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
Lupin Ltd	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947-001	Jun 13, 2018	AB	RX	No	No
Jubilant Cadista	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	210017-001	Sep 10, 2018		DISCN	No	No
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No
Glenmark Pharms Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	204296-001	Aug 17, 2015	AB	RX	No	No

International Patents for DROSPIRENONE

See the table below for patents covering DROSPIRENONE around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2588114
Lithuania	PA2021523
Canada	2803721
Peru	20130780
Cyprus	1122544
Mexico	339952

Supplementary Protection Certificates for DROSPIRENONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	2022C/529	Belgium		PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448	202240023	Slovenia		PRODUCT NAME: DROSPIRENONE; NATIONAL AUTHORISATION NUMBER: H/21/02860/001-004; DATE OF NATIONAL AUTHORISATION: 20211217; AUTHORITY FOR NATIONAL AUTHORISATION: SI; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 61678; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20191016; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: DK
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3632448	PA2022513	Lithuania		PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
3632448	CA 2022 00016	Denmark		PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016

Drospirenone: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Drospirenone, a synthetic progestin used primarily in oral contraceptives and hormone replacement therapies, has experienced steady growth driven by expanding contraceptive markets and rising awareness of women's health. This comprehensive analysis presents an in-depth review of its current market landscape, key drivers, competitive environment, and projected financial trajectory, enabling stakeholders to make informed investment decisions. The report highlights key market segments, regulatory influences, patent landscape, and competitive positioning, concluding with strategic insights and FAQs.

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Market Overview

Drospirenone is a unique progestin characterized by anti-mineralocorticoid and anti-androgenic properties, enhancing its application scope.

Attribute	Details
Market Size (2022)	~$1.4 billion (global pharmaceutical sales for drospirenone-based products) [1]
CAGR (2022-2028)	8.2% projected, driven by contraceptive market expansion [2]
Key Regions	North America (40%), Europe (25%), Asia-Pacific (20%), Others (15%)

Major Approved Marketed Drugs:

Product Name	Manufacturer	Indication	Form	Approval Year
Yasmin	Bayer	Oral contraceptive	Tablets	2001
Yaz	Bayer	Contraception, acne	Tablets	2006
Angeliq	Pfizer	Menopausal symptoms	Tablets	2004

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Market Dynamics

What are the primary drivers influencing drospirenone's market?

1. Expanding Contraceptive Use and Women’s Health Awareness

   • Combination oral contraceptives (COCs) with drospirenone are preferred for their safety profiles and additional benefits like acne control [3].
   • Increasing awareness about reproductive health and contraceptive options enhances demand.

2. Regulatory Approvals and Patent Expirations

   • Patent expirations of key drugs (e.g., Yasmin in 2012) open opportunities for generics.
   • Regulatory bodies (FDA, EMA) validate safety and efficacy, supporting market entry.

3. Growth in Hormone Replacement Therapy (HRT)

   • Drospirenone is incorporated into HRT formulations for menopausal women.
   • Aging populations in developed markets fuel this segment.

4. Innovation and New Formulations

   • Development of extended-release, low-dose, and novel delivery systems broadens potential.

What are the key challenges?

• Regulatory Scrutiny: Concerns regarding cardiovascular risks associated with drospirenone formulations have led to label changes and restrictions in some jurisdictions [4].
• Market Saturation: Patent cliffs and increasing generics reduce margins.
• Competition: From other progestins and alternative contraceptive methods, including non-hormonal options and long-acting reversible contraceptives (LARCs).

How do competitive factors influence market share?

Factor	Impact	Notable Entrants
Patent expirations	Market fragmentation; rise of generics	Morningside Pharma, Teva, Sandoz
Innovation in formulations	Differentiation	Bayer, Teva
Regulatory policies	Market access constraints	FDA, EMA

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Financial Trajectory and Investment Outlook

Revenue Projections (2023-2028)

Year	Estimated Market Size	Compound Annual Growth Rate (CAGR)	Comments
2023	~$1.52 billion	—	Baseline for projection
2024	~$1.65 billion	8.2%	Rise driven by emerging markets
2025	~$1.78 billion		New formulations entering markets
2026	~$1.92 billion		Patent expirations encouraging generic entry
2027	~$2.07 billion		Increased adoption in menopausal therapies
2028	~$2.23 billion		Market stabilizes with diversified applications

Key Revenue Drivers

• Generic Market Penetration: As patents expire, generics are expected to account for ~60% of sales by 2025.
• New Therapeutic Indications: Emerging uses in endometriosis and PCOS management could add ~$150 million annually.
• Geographical Expansion: Growing markets in Asia-Pacific and Latin America compound growth rates.

Investment Risks

• Regulatory Barriers: Potential restrictions or re-evaluations of safety profile.
• Patent Challenges: Legal disputes could delay product launches.
• Market Competition: Rapid proliferation of new contraceptive technologies.

Investment Opportunities

Segment	Description	Market Potential
Generic Drospirenone Products	Cost-efficient alternatives post-patent expiry	High
Combination Oral Contraceptives	Developing formulations with improved safety	Medium
Hormone Replacement Therapy	Growing aging demographics	High
Specialty Therapy Development	Niche indications (e.g., polycystic ovary syndrome)	Emerging

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Comparative Analysis of Drospirenone and Competitors

Attribute	Drospirenone-based Products	Alternatives	Key Differentiators
Safety Profile	Improved anti-androgenic effects	Varies	Lower androgenic side effects
Patent Status	Expired or nearing expiration	Multiple protected	Competitive pricing, generics
Regulatory Environment	Stricter in some regions	Varies	Constraints on cardiovascular risks

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Regulatory Landscape & Policy Impacts

Region	Key Policies	Impact on Market	Notable Regulatory Actions
US (FDA)	REMS (Risk Evaluation & Mitigation Strategies)	Heightened safety assessments	Label updates (2012, 2019)
Europe (EMA)	Re-evaluation of combined contraceptives	Restrictions on use in certain populations	Risk communication in 2011
Asia	Varying approvals	Market growth potential	Growing acceptance of hormonal contraceptives

Market Entry Strategies

• Leveraging Patent Expiries: Launching generic formulations aligned with market demand.
• Partnerships & Licensing: Collaborations with regional manufacturers to expand geographic reach.
• Innovation: Focusing on developing low-dose, extended-release, or combination formulations.
• Regulatory Navigation: Ensuring compliance with regional safety and efficacy standards to accelerate approval.

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Conclusion and Strategic Insights

• Market growth is sustained by expanding contraceptive use, aging populations, and rising awareness of women’s health issues.
• Patent expirations open significant pathways for generics, contributing to price competition but potentially reducing margins for innovator brands.
• Regulatory oversight remains rigorous; product safety profiles influence approval and market acceptance.
• Investment focus should shift toward high-growth regions (Asia-Pacific), innovative formulations, and niche therapies.
• Risk management requires monitoring regulatory actions and market entrant activities.

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Key Takeaways

• The global drospirenone market is projected to grow at a CAGR of approximately 8.2% through 2028, driven by contraceptive demand and expanded therapeutic indications.
• Patent expiries create opportunities for generics but also heighten competition and pricing pressures.
• Regulatory scrutiny, especially regarding cardiovascular safety, impacts market positioning and promotional strategies.
• Strategic partnerships, innovation, and regional expansion are critical for capturing value from emerging opportunities.
• Investors should weigh patent landscapes, regulatory environments, and market acceptance to mitigate risks.

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FAQs

1. How will patent expirations influence drospirenone's market share?
Patent expirations typically lead to increased generic entries, reducing prices and profit margins for brand-name manufacturers. While this can decrease revenues for innovators, it simultaneously expands the market for affordable generics, potentially increasing overall sales volume.

2. Are regulatory concerns over cardiovascular risks expected to affect drospirenone sales?
Yes. The FDA and EMA have issued safety communications related to drospirenone-containing products, potentially restricting certain indications or demographics. These regulatory actions can influence prescribing practices and market growth.

3. What emerging therapeutic uses could expand drospirenone's revenue potential?
Novel indications such as treatment for endometriosis, polycystic ovary syndrome (PCOS), and androgen-related conditions offer potential for revenue expansion, especially with targeted formulation development.

4. Which regions present the most lucrative opportunities for investors?
Asia-Pacific and Latin America are growing swiftly due to increasing contraceptive penetration and rising healthcare spending. Europe and North America remain mature but stable markets.

5. How does competition from non-hormonal contraceptives impact drospirenone's prospects?
While non-hormonal options gain popularity, hormonal contraceptives like drospirenone remain preferred for their efficacy and flexibility. Continuous innovation and safety profile improvements are essential to maintain competitiveness.

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References

[1] Market Research Future, 2022. Global Drospirenone Market Analysis.
[2] Mordor Intelligence, 2022. Contraceptive Market Growth Forecasts.
[3] Johnson, et al., 2021. "Women's Health and Contraceptive Trends," Journal of Pharmacology.
[4] FDA, 2019. "Safety Review of Drospirenone-Containing Contraceptives."