SKYLA Drug Patent Profile

Which patents cover Skyla, and what generic alternatives are available?

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			Y
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes			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
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013

International Patents for SKYLA

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

Country	Patent Number	Title	Estimated Expiration
Australia	4118096
Lithuania	1871314
European Patent Office	2352470
Brazil	PI0919228
Hungary	218760	Méhen belüli eszköz felhelyezésére szolgáló bevezetőeszköz és ezekből álló készlet (INSERTER FOR THE POSITIONING OF AN INTRAUTERINE DEVICE AND A SET OF THIS)
Norway	20051858
Spain	2108664

Supplementary Protection Certificates for SKYLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for SKYLA

Last updated: July 27, 2025

Introduction

SKYLA (levonorgestrel-releasing intrauterine system, or LNG IUS 13.5 mg) is a long-acting reversible contraceptive (LARC) developed and marketed by Bayer AG. Approved by the U.S. Food and Drug Administration (FDA) in 2013, SKYLA offers a contraceptive solution with a duration of action of up to three years. Its competitive positioning within the global contraceptive market and implications for Bayer's financial trajectory are influenced by an interplay of regulatory, demographic, technological, and competitive factors. This comprehensive analysis explores the market dynamics shaping SKYLA's performance and forecasts its financial trajectory over the coming years.

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Market Landscape and Growth Drivers

Global Contraceptive Market

The contraceptive market is experiencing steady growth, driven by rising awareness about family planning, increasing urbanization, and expanding healthcare infrastructure in emerging markets. The market’s valuation was estimated at over USD 22 billion in 2021, with a compound annual growth rate (CAGR) of approximately 5% projected through 2028 [1]. Long-acting reversible contraceptives (LARCs), including intrauterine devices (IUDs), have become a focal point, owing to their efficacy and convenience.

SKYLA’s Niche and Segment Positioning

SKYLA serves as an alternative to other hormonal IUDs like Mirena (Bayer) and Kyleena (udover), primarily targeting women seeking long-term contraception with minimal maintenance. Its unique selling points include its three-year duration, lower dose of levonorgestrel compared to Mirena, and a favorable safety profile, fostering acceptance among target populations such as women desiring discreet, reversible contraception.

Market Drivers

• Rising Adoption of LARCs: As healthcare providers and patients increasingly favor LARCs over oral contraceptives, SKYLA benefits from this paradigm shift. The WHO recommends LARCs as first-line options owing to their high efficacy and safety profile [2].

• Demographic Trends: Population growth in regions like Africa, Asia-Pacific, and Latin America amplifies potential user bases, especially as younger women seek reliable, long-term contraceptive solutions.

• Policy and Reimbursement: Government initiatives promoting family planning and insurance reimbursement schemes enhance accessibility, particularly in developed markets.

• Product Differentiation: SKYLA’s lower hormone dose and shorter duration appeal to women desiring flexible, reversible methods without the long-term commitment of devices like Mirena.

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Market Challenges and Competitive Dynamics

Regulatory and Reimbursement Challenges

While SKYLA is FDA-approved, regulatory pathways remain complex, especially for entering emerging markets. Price sensitivity and reimbursement policies influence penetration; for example, in the U.S., insurance coverage significantly affects patient access.

Competitive Landscape

Major competitors include:

• Mirena (Bayer): With a five-year duration, Mirena holds a larger market share owing to its longevity and established presence since 2000.

• Kyleena (Bayer): Offering a five-year duration, Kyleena targets women preferring a smaller device.

• ParaGard (TCu 380A): A copper IUD serving non-hormonal contraceptive needs.

• Other regional brands: Local manufacturers often provide more affordable options, especially in developing countries.

Pricing and Reimbursement Pressures

The competitive environment drives pricing pressures, with payers demanding cost-effective solutions. SKYLA's price point, relative to Mirena and Kyleena, directly influences its market share.

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Financial Trajectory and Revenue Outlook

Historical Performance

Bayer’s contraceptives division, spearheading SKYLA sales, has demonstrated consistent growth aligned with market expansion and product adoption. In fiscal year 2021, Bayer's woman’s healthcare segment, including contraceptive sales, recorded revenues of approximately EUR 2.3 billion, with long-acting contraceptives contributing a sizable share [3].

Projection for SKYLA

• Revenue Growth: Given industry trends, SKYLA is projected to grow at a CAGR of approximately 4-6% over the next five years, driven by increasing user acceptance and expanding geographical reach [4].

• Market Penetration Strategies: Bayer’s focus on increasing awareness campaigns, physician education, and expanding reimbursement coverage will bolster adoption rates.

• Emerging Markets Opportunity: As contraceptive access improves, SKYLA’s potential in emerging markets remains largely untapped, offering substantial upside.

• Patent and Market Exclusivity: SKYLA’s patent exclusivity extends until at least 2028, supporting premium pricing during this period.

Risks and Uncertainties

• Regulatory Approvals: Delays or rejections in key markets could hamper revenue growth.

• Competitive Innovation: Introduction of new devices or non-hormonal options could threaten SKYLA’s market share.

• Global Economic Factors: Currency fluctuations, inflation, and healthcare budget shifts influence affordability and reimbursement.

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Strategic Initiatives and Future Outlook

Bayer’s strategic focus includes:

• Product Line Expansion: Launching newer formulations, such as Kyleena, with overlapping features.

• Market Penetration: Accelerating sales in Asia-Pacific, Latin America, and Africa.

• Partnerships and Education: Collaborating with healthcare providers to increase awareness and utilization.

• Digital Initiatives: Utilizing telemedicine and digital marketing to reach younger demographics.

Forecast: Combining these strategies, SKYLA’s revenue is expected to maintain a steady upward trajectory, contributing positively to Bayer’s contraceptives revenue stream and overall financial health.

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Key Takeaways

• SKYLA occupies a growing niche within the global LARC market, bolstered by demographic trends and policy support favoring long-term contraception.

• Competitive pressures from Mirena and Kyleena, along with regional price sensitivities, shape SKYLA’s market share and revenue potential.

• Bayer’s strategic initiatives focusing on expanding global reach, educational campaigns, and product differentiation are crucial for sustaining growth.

• The five-year patent protection supports premium pricing, but upcoming biosimilar or generic entrants could induce competitive pricing pressures post-exclusivity.

• Overall, SKYLA is positioned for moderate growth, with significant upside potential in emerging markets and through strategic market development efforts.

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FAQs

1. When does SKYLA’s patent expire, and what implications does this have?
SKYLA’s patent protection is expected to expire around 2028, after which biosimilars or generics could enter the market, potentially reducing pricing power and revenue.

2. How does SKYLA compare to other intrauterine devices regarding duration and efficacy?
SKYLA provides three years of contraception, whereas Mirena and Kyleena offer five years. Efficacy rates are comparable across LARCs, with failure rates below 1%.

3. What are the primary markets for SKYLA beyond the U.S.?
Key markets include Europe, Canada, Australia, and increasingly, emerging economies in Asia and Latin America where contraceptive access improves.

4. How do reimbursement policies influence SKYLA’s sales?
Reimbursement coverage directly affects patient affordability, with insurance premiums and government programs playing pivotal roles in adoption rates.

5. What future innovations could impact SKYLA’s market position?
Advances in non-hormonal contraceptives, longer-lasting devices, and digital health integrations could redefine the competitive landscape, challenging SKYLA’s market share.

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Sources

1. [1] Grand View Research, "Contraceptive Market Size & Trends," 2022.
2. [2] World Health Organization, "Family Planning/Contraception," 2021.
3. [3] Bayer Annual Report 2021.
4. [4] MarketWatch, "Long-Acting Reversible Contraceptives Market Analysis," 2022.