YASMIN Drug Patent Profile

Which patents cover Yasmin, and when can generic versions of Yasmin launch?

Yasmin is a drug marketed by Bayer Hlthcare and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Yasmin

A generic version of YASMIN was approved as drospirenone; ethinyl estradiol by DR REDDYS LABS SA on September 7^th, 2010.

Summary for YASMIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	39
Patent Applications:	274
Drug Prices:	Drug price information for YASMIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YASMIN
What excipients (inactive ingredients) are in YASMIN?	YASMIN excipients list
DailyMed Link:	YASMIN at DailyMed

See drug prices for YASMIN

Recent Clinical Trials for YASMIN

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

Sponsor	Phase
Hansoh BioMedical R&D Company	PHASE1
Bio-innova Co., Ltd	PHASE1
Boehringer Ingelheim	PHASE1

See all YASMIN clinical trials

Paragraph IV (Patent) Challenges for YASMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YASMIN	Tablets	drospirenone; ethinyl estradiol	3 mg/0.03 mg	021098	1	2005-01-07

US Patents and Regulatory Information for YASMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	AB	RX	Yes	Yes

Expired US Patents for YASMIN

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	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	6,933,395
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	6,787,531

International Patents for YASMIN

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2269342	ФАРМАЦЕВТИЧЕСКАЯ КОМБИНАЦИЯ ЭТИНИЛЭСТРАДИОЛА И ДРОСПИРЕНОНА ДЛЯ ИСПОЛЬЗОВАНИЯ В КАЧЕСТВЕ КОНТРАЦЕПТИВА (PHARMACEUTICAL COMBINATION OF ETHYNYLESTRADIOL AND DROSPIRENONE FOR USING AS CONTRACEPTIVE)
Germany	19633685	Verfahren zur Herstellung von Drospirenon (6beta,7beta;15 beta,16beta-Dimethyl-en-3-oxo-17alpha-pregn-4-en-21,17-carbolacton, DRSP) sowie 7alpha-(3-Hydroxy-1-propyl)-6beta,7beta;15beta, 16beta-dimethylen-5beta-androstan-3beta,5,17beta-triol (ZK 92836) und 6beta,7beta;15beta,16beta-dimethylen-5beta-hydroxy-3-oxo-17alpha-androstan-21,17-carbolacton (90965) als Zwischenprodukte des Verfahrens (Production of drospirenone useful as steroidal agent)
Germany	122009000007
Bulgaria	102976
Denmark	1149841
Spain	2106728
Germany	59712991

Supplementary Protection Certificates for YASMIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0398460	CA 2001 00011	Denmark
0398460	300221	Netherlands		300221, 20100516, EXPIRES: 20150306
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008

Market Dynamics and Financial Trajectory for YASMIN: A Comprehensive Analysis

Last updated: July 29, 2025

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Introduction

YASMIN, a combined oral contraceptive (COC) developed by Bayer, has secured a significant position within the global reproductive health market. Launched in the early 2000s, YASMIN has gained recognition not only for its contraceptive efficacy but also for its unique formulation, combining drospirenone with ethinylestradiol. Its market trajectory is influenced by diverse factors spanning regulatory environments, competitive landscape, demographic shifts, and evolving consumer preferences. This analysis details the current market dynamics and evaluates the financial trajectory of YASMIN through the lens of industry trends, regulatory impacts, patent considerations, and emerging opportunities.

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Market Landscape and Key Drivers

Global Market Size and Growth Trends

The global oral contraceptives market was valued at approximately USD 9 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% projected through 2030 (source: MarketsandMarkets[1]). The increasing awareness of family planning, rising female workforce participation, and expanding healthcare access are primary drivers influencing this growth. YASMIN, as a premium product focusing on unique benefits and safety profiles, captures a substantial share within the segment of modern COCs.

Demographic and Socioeconomic Factors

Population segments of reproductive age (15-49 years) constitute the primary consumer base. Developing regions, especially Asia-Pacific and Latin America, are witnessing rapid growth due to improving healthcare infrastructure and changing societal norms around contraception. Conversely, mature markets like North America and Western Europe show stability, with a bias towards newer formulations and lifestyle-oriented products.

Product Efficacy and Safety Profile

YASMIN distinguishes itself through its combination of drospirenone, a potassium-sparing progestin, and low-dose ethinylestradiol, conferring benefits such as reduced water retention and a potentially lower risk of certain side effects. Its safety profile aligns with the preferences of women seeking hormone-based contraceptives that minimize adverse effects, fueling demand and prescribing patterns.

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Regulatory Environment and Patent Landscape

Regulatory Approvals and Labeling

YASMIN’s approval by consistent regulatory bodies such as the FDA, EMA, and other global agencies affirms its safety and efficacy. Regulatory adaptations, including updated labeling for thrombosis risk (noted in drospirenone-based contraceptives), have influenced prescribing behaviors and market positioning[2].

Patent Expiry and Generic Competition

Bayer held key patents for YASMIN until their expiry around 2013, enabling generic manufacturers to introduce bioequivalent formulations. The proliferation of generics has exerted downward pressure on prices, impacting revenue streams. While Bayer maintains patent protections for specific formulations and delivery mechanisms, patent cliffs remain a strategic challenge.

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Competitive Dynamics

Product Portfolio and Market Share

YASMIN faces competition from other drospirenone-based COCs, such as Yasminelle, and alternative hormonal contraceptives like levonorgestrel-based pills, intrauterine devices (IUDs), and patches. Market share is maintained through brand loyalty, clinical efficacy, and perceived safety benefits.

Emergence of New Technologies

Innovative contraceptives, including long-acting reversible contraceptives (LARCs) and hormone-free options, are gaining traction, necessitating strategic adaptations from YASMIN’s manufacturer. Additionally, digital health tools and telemedicine influence consumer engagement and product adherence.

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Financial Trajectory Analysis

Revenue Trends

Post-patent expiration, Bayer experienced initial revenue declines from YASMIN due to generic competition. However, strategic marketing and formulation enhancements have stabilized sales in key markets. In 2021, YASMIN’s global sales were estimated at USD 300 million, with regional variations reflecting market maturity[3].

Profitability and Cost Structure

Profit margins are influenced by manufacturing costs, regulatory compliance, and marketing expenditure. Patent protections shield profits temporarily; however, when these expire, pricing dynamics shift towards commodification, reducing margins. Bayer’s investment in lifecycle management and formulation improvements aims to sustain profitability.

Emerging Opportunities

Expanding indications, such as management of acne or hormonal regulation, present avenues to diversify revenue. Moreover, integrating YASMIN within comprehensive women’s health platforms can enhance market presence. The growth of emerging markets offers long-term revenue potential despite pricing pressures.

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Market Challenges and Risks

• Regulatory Risks: Ongoing safety reviews and potential restrictions on drospirenone formulations could impact YASMIN’s market access.
• Legal and Litigation Risks: Past litigations related to contraception safety have led to financial liabilities and reputational concerns.
• Market Entry Barriers: Entrenched competition and patent strategies complicate entry into new regions.
• Consumer Preference Shifts: A paradigm shift toward non-hormonal methods or LARCs may reduce demand.

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Strategic Outlook

YASMIN’s future financial trajectory hinges on differentiating through improved formulations, expanding indications, and adapting to regulatory landscapes. Bayer’s focus on lifecycle management, including new delivery systems and digital health integrations, aims to extend product relevance and sustain revenue streams.

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Key Takeaways

• The global contraceptive market is experiencing steady growth driven by demographic shifts and increasing healthcare access, benefiting products like YASMIN.
• Patent expirations have introduced competitive pressure, yet Bayer maintains revenue through product lifecycle management and formulations tailored to consumer safety preferences.
• Regulatory considerations, safety concerns, and litigation risks remain pivotal, necessitating active compliance and communication strategies.
• Growing acceptance of alternative and innovative contraceptive methods challenges YASMIN’s market dominance but also presents opportunities for expansion.
• Strategic diversification into broader women’s health domains and digital integration can bolster YASMIN’s financial trajectory in mature and emerging markets.

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FAQs

1. How does YASMIN differentiate itself from other oral contraceptives?
YASMIN combines drospirenone with low-dose estrogen, offering a unique safety and side effect profile, particularly for women seeking reduced water retention and certain hormonal benefits, setting it apart from traditional levonorgestrel-based pills.

2. What impact have patent expirations had on YASMIN’s sales?
Patent expiry around 2013 led to increased generic competition, exerting downward pressure on prices and margins. Bayer has focused on formulation innovations and brand loyalty to sustain sales.

3. Are there safety concerns affecting YASMIN’s market?
Yes, drospirenone-based contraceptives face scrutiny over thrombotic risks. Regulatory updates, including labeling modifications, influence prescribing patterns but haven’t significantly diminished overall demand.

4. What emerging markets offer growth opportunities for YASMIN?
Asia-Pacific, Latin America, and parts of Africa are witnessing growing contraceptive markets, driven by demographic changes and healthcare infrastructure development, representing long-term expansion areas.

5. How is Bayer positioning YASMIN amid the shift toward non-hormonal and long-acting contraception?
Bayer is investing in product lifecycle management, exploring additional indications, and integrating digital health tools to maintain relevance amid evolving consumer preferences.

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References

[1] MarketsandMarkets. "Oral Contraceptives Market by Product, Application, and Region." 2022.
[2] U.S. Food and Drug Administration. "Oral Contraceptives: Labeling Updates." 2020.
[3] Bayer Annual Report 2021.