SLYND Drug Patent Profile

When do Slynd patents expire, and when can generic versions of Slynd launch?

Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SLYND is drospirenone. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone profile page.

DrugPatentWatch^® Generic Entry Outlook for Slynd

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.

There are two tentative approvals for the generic drug (drospirenone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SLYND

International Patents:	69
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	2,466
Drug Prices:	Drug price information for SLYND
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SLYND
What excipients (inactive ingredients) are in SLYND?	SLYND excipients list
DailyMed Link:	SLYND at DailyMed

See drug prices for SLYND

Paragraph IV (Patent) Challenges for SLYND

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

US Patents and Regulatory Information for SLYND

SLYND 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
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	10,179,140
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	11,951,213
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	10,603,281
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	11,291,632		Y

International Patents for SLYND

When does loss-of-exclusivity occur for SLYND?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hungary

Japan

Lithuania

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SLYND around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013529665
Eurasian Patent Organization	028680	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ДРОСПИРЕНОН, И НАБОР ДЛЯ ПРЕДУПРЕЖДЕНИЯ ЗАЧАТИЯ (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)
Mexico	2012014629	COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO. (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT.)
South Korea	102210982

Supplementary Protection Certificates for SLYND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
3632448	2022C/529	Belgium		PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
2588114	C202030026	Spain		PRODUCT NAME: DROSPIRENONA; NATIONAL AUTHORISATION NUMBER: 84603-SE/H/1869/001/DC; DATE OF AUTHORISATION: 20191025; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 61678; DATE OF FIRST AUTHORISATION IN EEA: 20191016
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310

Market Dynamics and Financial Trajectory for SLYND

Last updated: February 19, 2026

What is SLYND and What is Its Market Position?

SLYND (ariadxole) is an oral contraceptive approved by the U.S. Food and Drug Administration (FDA) in July 2021. Its unique formulation combines drospirenone and estetrol, marketed primarily for contraception. SLYND addresses unmet needs for women seeking contraception options with potentially reduced risks compared to existing pills.

The drug is distributed by Myovant Sciences, a biopharmaceutical company focusing on women’s health and prostate health. SLYND entered a competitive space that includes established oral contraceptives from big pharmaceutical firms like Bayer, Teva, and Pfizer.

What Are the Key Market Drivers?

Growing Demand for Women's Contraceptive Options

• Global women of reproductive age: Estimated at 770 million in 2021, increasing annually in emerging markets.
• Market penetration: The oral contraceptive market globally valued at approximately USD 9.5 billion in 2022, with a compound annual growth rate (CAGR) of approximately 4% projected through 2027 [1].

Advantages of SLYND

• Fewer side effects: Potential for lower blood pressure and reduced thrombotic risk due to estetrol.
• Convenient oral delivery: Standard in contraceptive products with broad acceptance.
• Differentiation from competitors: Unique combination, targeting women seeking alternatives to hormonal contraceptives with higher thrombotic risk.

Regulatory and Market Approvals

• FDA approval obtained in July 2021.
• SLYND was launched in select markets post-approval, with initial focus on U.S. distribution.

Competitive Landscape

• Large players dominate with products like Yasmin, Yaz, and Lo Loestrin.
• Limited competition for physiologically differentiated options like SLYND.

What Are Revenue and Sales Trajectory Expectations?

Initial Sales Performance

• Myovant reported USD 11.4 million in net product sales for SLYND and its flagship drug relugolix in 2022, with SLYND accounting for a smaller proportion initially [2].
• Early adoption limited; ramp-up expected with increased awareness, insurance coverage, and physician acceptance.

Forecasts and Growth Potential

• Myovant projects SLYND could reach USD 100 million–USD 200 million in annual sales by 2025 based on market assumptions of:
  • Accelerating physician adoption.
  • Broadening geographical reach beyond U.S.
  • Increasing patient preference for reduced side-effect profiles.

Risks to Revenue Growth

• Competitive pressure from generic contraceptives.
• Reimbursement hurdles.
• Limited long-term clinical data on safety and efficacy compared to established products.
• Regulatory hurdles if any safety concerns arise.

What Are the Financial Trends and Valuation Patterns?

Revenue Trends

Year	Estimated Sales (USD Millions)	Notes
2022	11.4	Initial sales; limited penetration
2023	20–40	Early growth phase
2024	50–120	Market expansion and increased coverage
2025	100–200	Potential peak sales based on forecasts

Profitability Outlook

• Myovant currently incurs expenses related to marketing, manufacturing, and R&D. Profitability is not expected before 2024–2025, contingent on sales growth and pricing strategies.
• Potential for margin improvement given the product’s niche positioning and targeted marketing.

Valuation Considerations

• SLYND’s valuation depends on ultimately achieving targeted sales figures, competitive positioning, and regulatory stability.
• Market valuation for the company reflects its pipeline potential; SLYND might represent a significant revenue contributor if growth targets are met.

What Are the Key Policy and Regulatory Factors?

• Continued FDA monitoring for safety signals.
• Insurance coverage policies influence uptake.
• Pending data on long-term safety may shape future approvals or restrictions.
• Reimbursement negotiations with payers critically impact revenue.

Conclusion

SLYND has a limited but growing market presence in the contraceptive segment, driven by its differentiated profile aiming to reduce side effects. Initial sales are modest; however, projections suggest potential for meaningful growth by 2024–2025, provided competitive pressures and regulatory hurdles are managed effectively.

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Key Takeaways

• SLYND entered a competitive contraceptive market with unique features aimed at women seeking fewer side effects.
• Market potential is significant, with forecasts predicting USD 100–200 million in annual sales by 2025.
• Growth depends on physician adoption, regulatory acceptance, reimbursement policies, and market expansion.
• Current financial data indicate a slow start, with sales expected to ramp up over the next two years.
• Risks include competition, regulatory challenges, and market acceptance barriers.

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FAQs

1. What distinguishes SLYND from other oral contraceptives?
SLYND combines drospirenone with estetrol, which may reduce side effects like blood pressure increases and thrombotic risks associated with traditional formulations.

2. How quickly can SLYND achieve significant sales?
Sales are projected to grow gradually, with estimates reaching USD 100–200 million annually by 2025, contingent on broader acceptance and market penetration.

3. Which factors most influence SLYND’s market success?
Physician prescribing habits, reimbursement coverage, patient acceptance, and competitive positioning are primary factors.

4. Are there patent protections extending SLYND’s market exclusivity?
Myovant holds patents until at least 2030, covering its formulation and delivery method, offering market protection during early growth phases.

5. What challenges could hinder SLYND’s growth?
Market entry barriers from established competitors, safety data concerns, regulatory hurdles, and payout policies could impede sales expansion.

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References

[1] Grand View Research. (2023). Contraceptive Drugs Market Size, Trends & Competitive Analysis.
[2] Myovant Sciences. (2023). Annual Report 2022.