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. Sixteen 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
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001

International Patents for YASMIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	2010226924
World Intellectual Property Organization (WIPO)	0117685
Hungary	903045
Hungary	0202500
China	1407895
Croatia	P20020258	FARMACEUTSKA KOMBINACIJA ETINILESTRADIOLA I DROSPIRENONA ZA UPOTREBU KAO KONTRACEPCIJSKOG SREDSTVA (PHARMACEUTICAL COMBINATION OF ETHINYLESTRADIOL AND DROSPIRENONE FOR USE AS A CONTRACEPTIVE)

Supplementary Protection Certificates for YASMIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0398460	91065	Luxembourg		91065, EXPIRES: 20150516
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1380301	SPC019/2009	Ireland		SPC019/2009: 20091119, EXPIRES: 20220628

Market Dynamics and Financial Trajectory for YASMIN

Last updated: February 19, 2026

What is the current market position of YASMIN?

YASMIN is a combined oral contraceptive (COC) containing drospirenone and ethinyl estradiol. Since its FDA approval in 2006, it has maintained a significant share of the oral contraceptive market, especially in the United States. It competes primarily with other drospirenone e see formulations, such as Yaz and Yasminelle, but also with generic versions of ethinyl estradiol-based pills.

In 2021, YASMIN generated approximately $500 million in U.S. sales (EvaluatePharma, 2022). Its global reach extends to Europe and select markets in Latin America. Despite a gradual decline from peak revenues of over $600 million in 2014, it remains a key product for Bayer, which acquired the rights from Schering-Plough and later merged it into its portfolio.

How does market competition influence YASMIN’s performance?

YASMIN faces competition from several fronts:

• Generics: Entry of generic drospirenone and ethinyl estradiol tablets from multiple manufacturers has eroded branded sales. Generic versions, often priced below branded YASMIN, compromise profit margins.
• Other contraceptives: Non-hormonal methods, long-acting reversible contraceptives (LARCs), and newer hormonal combinations attract consumers seeking different profiles or side-effect considerations.
• Regulatory and safety concerns: Reports claiming a higher risk of venous thromboembolism (VTE) with drospirenone-containing pills have led to negative publicity, impacting prescriptions and sales.

This competition pressures Bayer to innovate or reposition YASMIN to sustain sales.

What are the key factors affecting YASMIN’s financial trajectory?

Patent and exclusivity status

YASMIN’s primary patent protections expired around 2012 in the U.S., opening the market to generics. However, Bayer maintains secondary patents on formulation specifics and delivery mechanisms, attempting to extend market exclusivity through patent lawsuits and formulations:

• Patent Litigation: Ongoing efforts to defend against generic challenge.
• Market exclusivity: Limited until 2024 due to patent expirations, after which price erosion is expected to accelerate.

Pricing strategy

Pricing has been adjusted in response to generic competition, with brand premiums declining from roughly $50 per pack in 2012 to around $20 in 2021 (IQVIA, 2022). Margin impact from these adjustments influences overall profitability.

Regulatory landscape

Enhanced safety warnings and post-marketing studies have led to regulatory scrutiny. The FDA issued safety alerts in 2011 and 2014, which affected prescribing patterns. These constraints restrict marketing claims, indirectly influencing sales volume.

Market demand and demographic trends

Increasing awareness of non-hormonal alternatives and the aging population seeking hormonal therapy influence YASMIN’s demand. Its target demographic primarily consists of women aged 15-35, with some declining due to safety concerns.

Patent expirations and generic entry

Forecasts indicate a substantial initiation of generic drospirenone/ethinyl estradiol products post-2024, intensifying price competition. YASMIN’s revenue is projected to decline by approximately 20-30% annually after patent expiry, assuming no repositioning or reformulation.

What are future strategic considerations?

• Product differentiation: Bayer has explored reformulations targeting specific populations or delivering additional benefits.
• Diversification: Expanding into other hormonal therapies or contraceptive markets can offset decline.
• Pricing and discounts: Competitive strategies may include rebates or patient assistance programs to maintain market share.
• Regulatory engagement: Continual risk assessments and safety communications are necessary to preserve market access.

Summary of Financial Outlook

Year	Estimated Revenue (USD millions)	Key Factors
2022	500	Market stabilization, patent protections intact
2024	350-400	Patent expiration, onset of generic competition
2025+	250-300	Increased generic penetration, declining brand sales

Key Takeaways

• YASMIN’s market share remains significant but erodes due to patent expiration and increased competition.
• Revenue is declining at an estimated rate of 20-30% annually post-2024.
• Patent protections and regulatory concerns influence strategic market movements.
• Competition through generics is the primary driver of revenue decline.
• Bayer’s future focus includes product innovation and diversification to mitigate losses.

FAQs

1. How does patent expiry affect YASMIN’s profitability?
Patent expiry allows generic manufacturers to enter the market, significantly lowering prices and reducing YASMIN’s profit margins.

2. Are safety concerns influencing YASMIN sales?
Yes, reports linking drospirenone to increased VTE risk have led to decreased prescriptions and political pressure on marketing.

3. Can product reformulation extend YASMIN’s market life?
Potentially, reformulations may help differentiate from generics, but regulatory approval and efficacy validation are required.

4. What is the projected impact of generics entering the market?
Post-2024, generic competition could reduce YASMIN’s revenue by 20-30% annually unless mitigated by strategic adjustments.

5. How does regulatory environment influence future sales?
Ongoing safety monitoring and restrictions on marketing claims may limit outreach, impacting sales volumes.

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References
[1] EvaluatePharma. (2022). Sales data for YASMIN.
[2] IQVIA. (2022). Market analysis for contraceptives.