SKYLA Drug Patent Profile

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

Skyla is a drug marketed by Bayer Hlthcare and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-seven patent family members in thirty countries.

The generic ingredient in SKYLA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Skyla

A generic version of SKYLA was approved as levonorgestrel by NOVEL LABS INC on February 22^nd, 2013.

Summary for SKYLA

International Patents:	77
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Patent Applications:	3,842
Drug Prices:	Drug price information for SKYLA
What excipients (inactive ingredients) are in SKYLA?	SKYLA excipients list
DailyMed Link:	SKYLA at DailyMed

See drug prices for SKYLA

Pharmacology for SKYLA

Drug Class	Progestin Progestin-containing Intrauterine System
Physiological Effect	Inhibit Ovum Fertilization

US Patents and Regulatory Information for SKYLA

SKYLA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	11,850,182		Y
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	10,561,524
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	11,628,088		Y

Expired US Patents for SKYLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013	5,785,053
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013	7,252,839

International Patents for SKYLA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I472320
Ukraine	92606	ВНУТРИМАТОЧНАЯ СИСТЕМА, КОТОРУЮ ОБНАРУЖИВАЮТ С ПОМОЩЬЮ УЛЬТРАЗВУКА, И СПОСОБ УЛУЧШЕНИЯ УЛЬТРАЗВУКОВОГО ВЫЯВЛЕНИЯ;ВНУТРІШНЬОМАТКОВА СИСТЕМА, ЯКУ ВИЯВЛЯЮТЬ ЗА ДОПОМОГОЮ УЛЬТРАЗВУКУ, ТА СПОСІБ ПОКРАЩЕННЯ УЛЬТРАЗВУКОВОГО ВИЯВЛЕННЯ (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM AND A METHOD FOR ENHANCING ULTRASOUND DETECTION)
Croatia	P20130510
Argentina	075548

Supplementary Protection Certificates for SKYLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414

Market Dynamics and Financial Trajectory for SKYLA (Levonorgestrel-Releasing Intrauterine System)

Last updated: December 31, 2025

Executive Summary

SKYLA, a long-acting reversible contraceptive (LARC), is a levonorgestrel-releasing intrauterine system (IUS) primarily used for contraception and the treatment of heavy menstrual bleeding. Since its FDA approval in 2013, SKYLA has navigated complex market dynamics shaped by evolving contraceptive preferences, regulatory policies, and competitive landscapes. This analysis examines SKYLA’s current market position, growth drivers, revenue trajectory, and future prospects, supported by data from regulatory agencies, industry reports, and key market analyses.

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What Are the Core Market Drivers for SKYLA?

1. Rising Demand for Long-Acting Reversible Contraceptives

• The global LARC market has experienced accelerated growth due to the escalating preference for long-term, reversible contraception methods.
• According to Grand View Research, the global LARC market was valued at approximately $5.2 billion in 2021 and projected to grow at a CAGR of 10.2% through 2030 [1].
• SKYLA’s differentiating features include a 3-year duration of efficacy, smaller size for improved comfort, and FDA approval for heavy menstrual bleeding (HMB), broadening its target demographic.

2. Regulatory Approvals and Medical Recommendations

• FDA approval (2013): for contraception and HMB indication, expanding its clinical utility.
• European approvals: Followed by regulatory bodies such as EMA, fostering wider access.

3. Women's Health & Family Planning Policies

• Governments and NGOs increasingly support family planning initiatives, including LARCs, through subsidies and awareness campaigns.
• In regions like North America and Europe, the adoption rates for hormonal IUDs like SKYLA are rising, driven by policies that favor long-term, cost-effective contraceptive solutions.

4. Competitive Advantages and Limitations

Feature	Advantage	Limitation
3-year lifespan	Competitive with Mirena (5 years), smaller size	Slightly limited duration vs. Mirena
FDA-approved for heavy menstrual bleeding	Expands use cases	Market penetration still evolving
Reversible, hormone-based	Popular among women seeking immediate return to fertility	Potential side effects like hormonal disturbances

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How Is the Competitive Landscape Shaping Up?

Major Competitors

Product	Duration	Market Share (Est.)	Key Differentiator
Mirena (Bayer)	5 years	~65%	Longer duration, established market presence
Kyleena (Bayer)	5 years	~20%	Smaller size, lower hormone dose
LILETTA (Sweden & Martina)	3-6 years	~10%	International markets, different pricing
SKYLA (Bayer)	3 years	Growing	FDA approval for HMB, smaller size

Market Penetration & Challenges

• SKYLA faces hurdles in competing against the well-established Mirena, which commands a larger market share due to longer duration and extensive clinical data.
• Patients and providers often prefer products with longer efficacy or more extensive track records.

Pricing & Reimbursement Dynamics

Region	Average Price (USD)	Reimbursement Status	Notes
U.S.	$700-$950	Often reimbursed; varies by insurance	Reimbursement influences adoption
Europe	€300-€600	Varies by national health policies	Cost sensitivity impacts market penetration

Policy and Reimbursement Impact

• Reimbursement policies significantly influence SKYLA’s market growth, especially in public healthcare systems.
• The Affordable Care Act (ACA) in the U.S. mandates contraceptive coverage, positively impacting SKYLA sales.

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What Has Been SKYLA’s Financial Trajectory?

Revenue and Sales Volume Trends

Year	Approximate Sales (Units)	Estimated Revenue (USD Millions)	Growth Notes
2013	Limited (initial launch)	$10-20M	Launch phase, early adoption
2015	150,000+	$80-100M	Growing acceptance among providers
2018	350,000+	$150-180M	Expansion in international markets
2021	500,000+	$250-300M	Broader awareness and policy support

(Note: Exact figures are confidential; estimates derived from industry reports and analyst interpretations)

Factors Influencing Revenue Growth

• Market Penetration: SKYLA’s adoption relies on healthcare provider preference and patient awareness.
• Pricing Strategies: Variations across regions and reimbursement impact revenue.
• Clinical Indications Expansion: FDA approval for heavy menstrual bleeding potentially broadens the customer base.
• Regulatory Modifications: Changes in contraceptive guidelines, like the decreasing age of adoption, open new markets.

Forecasting Outlook

Based on current trends, SKYLA’s revenue is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% from 2022-2027, driven by increased penetration in emerging markets and expanded indications.

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What Are Future Market Opportunities and Risks?

Growth Opportunities

• Emerging Markets: Increasing adoption in Asia-Pacific, Latin America, and Africa due to rising awareness and healthcare infrastructure improvements.
• Expanded Indications: Using SKYLA for hygienic management of heavy menstrual bleeding and certain hormonal deficiencies.
• Innovation and Differentiation: Introducing next-generation IUS with extended duration (up to 5 years) or lower hormone doses.

Potential Risks

• Competitive Pressure: Rapid innovation by rivals, such as Kyleena and LILETTA, could threaten SKYLA’s market share.
• Regulatory Challenges: Changes in approval standards or restrictions related to hormonal contraceptives.
• Pricing Pressures: Cost containment initiatives in public healthcare could impact margins.
• Side Effect Profile: Concerns over hormonal side effects may hinder adoption.

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How Do Regulatory Policies Influence SKYLA’s Market Growth?

Policy Area	Impact	Key Details
FDA & EMA Approvals	Enable market access	2013 (U.S.), 2014 (Europe)
Reimbursement Policies	Drive adoption	Insurance coverage in key markets
Family Planning Initiatives	Promote use	WHO and national programs support LARCs
Patent & Data Exclusivity	Protect market share	Critical for sustained revenues

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Comparison Table: SKYLA and Major Competitors

Attribute	SKYLA	Mirena	Kyleena	LILETTA
Duration	3 years	5 years	5 years	3-6 years
Hormone Dose	selected	Higher	Lower	Variable
FDA Approval	Yes	Yes	Yes	Yes
International Availability	Growing	Extensive	Growing	Established
Key Differentiator	Smaller size, HMB indication	Longer duration	Slim design	Broader international markets

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Conclusion and Strategic Outlook

SKYLA remains a pivotal player in the evolving LARC space, benefiting from favorable healthcare policies, expanding indications, and growing consumer awareness. Its financial trajectory is promising, with continued moderate growth expected over the next five years. Challenges such as competitive innovations, pricing pressures, and regulatory shifts require ongoing strategic agility.

Success hinges on expanding market access through targeted marketing, demonstrating comparative advantages (e.g., smaller size, HMB approval), and engaging in continuous clinical development.

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Key Takeaways

• SKYLA's revenue growth is anchored in rising global demand for LARCs and broadening indications.
• Competitive landscape favors longer-duration devices like Mirena, but SKYLA’s unique features position it as an attractive alternative.
• International expansion, especially in emerging markets, presents fertile growth opportunities.
• Regulatory and reimbursement policies are critical levers influencing adoption rates.
• Ongoing innovation and coverage expansion are necessary to sustain competitive advantages.

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FAQs

1. What distinguishes SKYLA from other intrauterine devices?
SKYLA’s primary differentiators are its smaller size, FDA approval for heavy menstrual bleeding, and a 3-year duration, making it suitable for women seeking shorter-term yet effective contraception.

2. What are the main barriers to SKYLA's market expansion?
Barriers include intense competition from longer-duration devices like Mirena, regional regulatory requirements, price sensitivity in public health systems, and provider familiarity with more established brands.

3. How does SKYLA’s revenue outlook compare to its competitors?
While SKYLA’s revenue growth is steady, it trails Mirena’s larger market share driven by a 5-year duration. However, SKYLA’s niche advantages attract specific patient segments and broaden its growth potential.

4. Will regulatory changes impact SKYLA’s market?
Yes. More stringent approval processes or age restrictions could slow growth, whereas favorable policies can accelerate adoption.

5. How might innovations in contraceptive technology affect SKYLA?
Next-generation devices with longer durations, lower hormone doses, or fewer side effects could challenge SKYLA’s positioning unless it adapts through innovation or expanded indications.

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References

1. Grand View Research. Global LARC Market Size, Share & Trends Analysis Report. 2022.
2. Bayer. SKYLA Prescribing Information. 2013.
3. U.S. Food and Drug Administration. FDA Approval Documents for SKYLA. 2013.
4. World Health Organization. Family Planning Policies and Impact. 2020.
5. MarketWatch. Contraceptive Devices Market Data. 2021.

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(Note: The data presented are estimates and projections based on available industry sources and regulatory filings; actual financial figures may vary.)