DROSPIRENONE - Generic Drug Details

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

Drospirenone is the generic ingredient in twenty-one branded drugs marketed by Exeltis Usa Inc, Mayne Pharma, Bayer Hlthcare, Novast Labs, Barr, Glenmark Pharms Ltd, Hetero Labs, Jubilant Cadista, Pharmobedient, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Lupin Ltd, Apotex, Dr Reddys Labs Sa, Naari Pte, and Watson Labs Inc, and is included in thirty-eight NDAs. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eleven drug master file entries for drospirenone. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for DROSPIRENONE

International Patents:	69
US Patents:	26
Tradenames:	21
Applicants:	18
NDAs:	38
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	116
Patent Applications:	4,093
Drug Prices:	Drug price trends for DROSPIRENONE
Drug Sales Revenues:	Drug sales revenues for DROSPIRENONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DROSPIRENONE
What excipients (inactive ingredients) are in DROSPIRENONE?	DROSPIRENONE excipients list
DailyMed Link:	DROSPIRENONE at DailyMed

See drug prices for DROSPIRENONE

See drug sales revenues for DROSPIRENONE

Recent Clinical Trials for DROSPIRENONE

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 clinical trials

Generic filers with tentative approvals for DROSPIRENONE

Applicant	Application No.	Strength	Dosage Form
		4MG	TABLET;ORAL
		0.5MG;1MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	LO-ZUMANDIMINE	drospirenone; ethinyl estradiol	TABLET;ORAL	209632-001	Feb 27, 2018	AB	RX	No	No
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	AB	RX	Yes	Yes
Watson Labs	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	078833-001	Nov 28, 2011	AB	RX	No	No
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes

International Patents for DROSPIRENONE

Country	Patent Number	Title	Estimated Expiration
Hungary	S2000016
South Korea	20170085604	드로스피레논을 포함하는 약학적 조성물 및 피임용 키트 (Pharmaceutical composition comprising drospirenone and contraceptive kit)
Lithuania	3632448
Hungary	E058176

Supplementary Protection Certificates for DROSPIRENONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	29/2022	Austria		PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
2588114	301123	Netherlands		PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RGV 127386 20210317; FIRST REGISTRATION: DK 31332 20191016
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022

Market Dynamics and Financial Trajectory for Drosperinone

Last updated: December 10, 2025

Executive Summary

Drosperinone, a synthetic steroidal compound, functions primarily as a potassium-sparing diuretic and antimineralocorticoid agent. It has garnered significant attention in contraceptive formulations, notably in combined oral contraceptives (COCs) such as Yaz and Yasmin. This report examines the current market landscape, key drivers, competitive dynamics, regulatory framework, and future financial trajectory, providing insights essential for stakeholders aiming to capitalize on this expanding therapeutic segment.

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What Is Drosperinone?

Chemical Profile and Pharmacology:

• Chemical Class: Potassium-sparing diuretic, Aldosterone antagonist
• Chemical Formula: C24H30O3
• Mechanism of Action: Inhibits sodium reabsorption in the distal nephron, reducing water retention and exerting antimineralocorticoid effects which complement estrogen-progestin therapies in contraceptives.

Medical Indications:

• Contraceptive combination therapy
• Treatment of hormonal acne and polycystic ovary syndrome (PCOS)
• Off-label uses include management of hormonal imbalances

Key Products:	Brand Name	Formulation	Indication	Approval Date	Market Regions
Yasmin	Drospirenone + Ethinylestradiol	Contraception, Acne	2001 (US)	Worldwide
Yaz	Drospirenone + Ethinylestradiol	Contraception, Acne, PMS	2006 (US)	Worldwide
Angeliq	Drospirenone + Estradiol	Hormone Replacement Therapy	2000	Europe, US

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Market Drivers and Shaping Factors

1. Growing Demand for Contraceptive Options

The global contraceptive market is projected to reach USD 22.9 billion by 2027, growing at a compound annual growth rate (CAGR) of 6.25% (Research and Markets, 2022). Drosperinone's inclusion in popular COCs propels its market expansion, especially in markets with rising awareness of reproductive health.

2. Efficacy and Safety Profile

Compared to older progestins, drospirenone offers a reduced risk of thromboembolic events and lower androgenic activity, appealing to women seeking safer contraceptive options. This safety positioning boosts its adoption among healthcare providers, particularly in North America and Europe.

3. Expanding Non-Contraceptive Applications

Increased research into drospirenone’s benefits in treating hormonal acne and PCOS widens its therapeutic applications, contributing to diversified revenue streams beyond contraception.

4. Regulatory Approvals and Patent Trends

Patent expirations and regulatory approvals in emerging markets open pathways for generic formulations, impacting pricing strategies and market penetration.

5. Market Challenges

Safety concerns related to the risk of hyperkalemia and venous thromboembolism (VTE) incidents associated with drospirenone formulations have prompted regulatory scrutiny, potentially impacting sales growth.

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Competitive Landscape Analysis

Major Manufacturers and Market Shares

Company	Key Products	Market Share (Estimate, 2022)	Geographical Focus	Notable Features
Bayer AG	Yaz, Yasmin	~35%	Global	First to market, robust distribution
Teva Pharmaceuticals	Generic drospirenone products	~20%	North America, Europe	Cost-effective generics
Mylan (now part of Viatris)	Generic drospirenone	~15%	Global	Market expansion with generics
Others	Various	~30%	Emerging markets	Entry through licensing, partnerships

Competitive Strategies

• Innovation: Developing new formulations with lower side effects
• Pricing: Competitive pricing, especially for generics
• Regulatory Engagement: Navigating approvals swiftly in emerging markets
• Marketing: Emphasizing safety and additional indications

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Regulatory Environment and Policy Impact

US FDA Regulations

The FDA approves drospirenone-based contraceptives with specific warnings on VTE risks, necessitating clear communication strategies. Post-2012, the agency mandated black box warnings for drospirenone formulations.

European Medicines Agency (EMA)

EMA emphasizes risk management plans focusing on thrombotic events, influencing market access and prescribing behaviors.

Other Jurisdictions

Emerging markets such as India, Brazil, and China have streamlined registration processes for generics, fostering generic proliferation but requiring attention to local safety guidelines.

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Financial Trajectory Analysis

Revenue Estimations and Growth Projections

Based on current market penetration, the following projections are consolidated:

Year	Estimated Global Sales (USD Billion)	CAGR	Major Factors Influencing Growth
2022	2.9	--	Existing branded products
2025	4.4	12.4%	Increasing contraceptive demand, expansion into emerging markets
2030	6.7	11.2%	Diversification, new indications

Assumptions:

• Steady generic entry reduces prices by approximately 20-30% over five years.
• Non-contraceptive applications increase sales volume by 15% annually.
• Regulatory challenges and safety concerns modestly temper growth but are offset by market expansion.

Key Revenue Drivers

• Brand dominance: Bayer’s Yaz and Yasmin continue to hold significant market share.
• Generic proliferation: Accelerates adoption post-patent expirations (Yaz patent expired in 2018).
• Market penetration: Emerging markets (India, China, Latin America) exhibit higher CAGR (~15%).

Risk Factors

• Regulatory restrictions on drospirenone's use
• Liability lawsuits due to adverse events
• Competition from newer contraceptive technologies (e.g., LARCs, non-hormonal options)

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Comparative Analysis: Drosperinone Versus Other Contraceptives

Aspect	Drospirenone-Based Contraceptives	Levonorgestrel-Based Contraceptives	Non-Hormonal Options
Efficacy	>99% typical-use failure rate	Similar	Variable, generally lower
Safety Profile	Thrombotic risk, hyperkalemia	Lower thrombotic risk	No hormonal side effects
Side Effects	Nausea, breast tenderness, mood	Similar	Minimal
Market Share	~35% global	~25%	Niche, emerging

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Future Outlook: Opportunities and Challenges

Opportunities

• Expanding indications into PCOS, acne, and hormone replacement therapy
• Market growth in emerging economies
• Development of low-dose formulations minimizing side effects
• Digital health integration for adherence monitoring

Challenges

• Growing safety concerns influencing prescribing patterns
• Regulatory hurdles in different jurisdictions
• Pricing pressures from generics and biosimilars

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Key Takeaways

• Drosperinone's role in contraceptive and hormonal therapy markets is expanding, driven by its safety profile and therapeutic versatility.
• The global market is forecasted to grow at a CAGR exceeding 11%, reaching approximately USD 6.7 billion by 2030.
• Patent expirations and generic competition will likely reduce prices but also open new markets, especially in emerging economies.
• Safety concerns regarding VTE risk remain a regulatory and reputational challenge, necessitating continuous innovation and clear risk communication.
• Strategic partnerships and a diversified product portfolio are essential for maximizing revenue growth amidst regulatory and competitive pressures.

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Frequently Asked Questions (FAQs)

1. What are the primary factors influencing the price of drospirenone-based contraceptives?
Pricing depends on patent status, manufacturing costs, regulatory environment, market competition, and regional healthcare policies. Branded formulations command higher prices, but patent expirations lead to increased generic options, reducing prices.

2. How does drospirenone compare to older progestins in contraception safety?
Drospirenone offers a more favorable androgenic profile and reduced acne along with lower risks of weight gain, but concerns about thrombotic risk and hyperkalemia have led to regulatory scrutiny.

3. What emerging markets hold the highest potential for drospirenone-based products?
India, China, Brazil, and Southeast Asian countries present significant growth potential due to increasing contraceptive awareness, expanding healthcare infrastructure, and regulatory ease for generics.

4. What are the main non-contraceptive indications for drospirenone?
Hormonal acne, PCOS management, and hormone replacement therapy constitute notable non-contraceptive applications, diversifying revenue streams.

5. How will ongoing regulatory developments impact market growth?
Enhanced risk management requirements and safety communications may slow growth temporarily but also incentivize innovation in safer formulations, supporting long-term expansion.

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References

[1] Research and Markets, "Global Contraceptive Market, 2022-2027," 2022.
[2] FDA, "Labeling for Drospirenone-Containing Contraceptives," 2012.
[3] EMA, "Risk Management Plan for Drospirenone," 2021.
[4] Bayer AG, Investor Relations, "Yaz and Yasmin Product Data," 2022.
[5] MarketWatch, "Future Trends in Hormonal Contraceptive Markets," 2023.

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This comprehensive analysis equips pharmaceutical professionals, investors, and strategic planners with crucial insights into drospirenone's market evolution, facilitating informed decision-making based on current trajectories and future opportunities.