KYLEENA Drug Patent Profile

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

Kyleena 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 KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kyleena

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

Summary for KYLEENA

International Patents:	77
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	3
Patent Applications:	3,748
Drug Prices:	Drug price information for KYLEENA
What excipients (inactive ingredients) are in KYLEENA?	KYLEENA excipients list
DailyMed Link:	KYLEENA at DailyMed

See drug prices for KYLEENA

Recent Clinical Trials for KYLEENA

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

Sponsor	Phase
Arkansas Children's Hospital Research Institute	Phase 4
Biós Farmacêutica	Phase 2
Science Valley Research Institute	Phase 2

See all KYLEENA clinical trials

Pharmacology for KYLEENA

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

US Patents and Regulatory Information for KYLEENA

KYLEENA 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	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes			Y
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes			Y

Expired US Patents for KYLEENA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016

International Patents for KYLEENA

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

Country	Patent Number	Title	Estimated Expiration
Norway	20051858
Austria	387898
World Intellectual Property Organization (WIPO)	2006106180
Mexico	2007011820	UN SISTEMA INTRAUTERINO DETECTABLE ULTRASONICAMENTE Y UN METODO PARA MEJORAR LA DETECCION DEL ULTRASONIDO. (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM AND A METHOD FOR ENHANCING ULTRASOUND DETECTION.)
Canada	2607079	SYSTEME INTRA-UTERIN DETECTABLE PAR ULTRASONS ET PROCEDE DESTINE A INTENSIFIER LA DETECTION PAR LES ULTRASONS (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM AND A METHOD FOR ENHANCING ULTRASOUND DETECTION)
World Intellectual Property Organization (WIPO)	2010031900

Supplementary Protection Certificates for KYLEENA

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	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; 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	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	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

KYLEENA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Kyleena

Overview of Kyleena

Kyleena is a progestogen-only, long-acting reversible contraceptive (LARC) intrauterine device (IUD) that contains 19.5 mg of levonorgestrel. It is indicated for the prevention of pregnancy for up to 5 years and is known for its low hormone levels and effective contraceptive efficacy[2][3][5].

Market Positioning

Kyleena was approved by the FDA in September 2016, marking a significant addition to the contraceptive devices market. This approval has contributed to the growth of Bayer AG's market share in the contraceptive devices sector. The global contraceptive devices market, which includes players like Pfizer Inc., Allergan, and Merck & Co., Inc., is fragmented but growing steadily[4].

Market Size and Growth

The global contraceptive devices market was valued at USD 7,013.8 million in 2017 and is projected to reach USD 16,648.3 million by 2032, growing at a CAGR of 6.0% during the forecast period. This growth is driven by increasing awareness among the general population, especially in emerging countries, and proactive initiatives by governments for population control[4].

Competitive Landscape

Kyleena competes directly with other LARC devices, most notably Mirena, which also contains levonorgestrel but at a higher dose (52 mg). Kyleena offers a lower dose of levonorgestrel, which results in fewer progestogen-related side effects, such as ovarian cysts, compared to Mirena. However, Kyleena has a slightly higher risk of unplanned pregnancy, although this difference is not statistically significant[2].

Cost-Effectiveness

The listing of Kyleena on the PBS General Schedule in Australia was based on its acceptable cost-effectiveness compared to Mirena. This cost-minimization approach highlights that Kyleena offers comparable contraceptive effectiveness at a lower cost, making it an attractive option for both patients and healthcare systems[2].

Efficacy and Safety

Kyleena has demonstrated high contraceptive efficacy, with a cumulative efficacy of 98.6% over 5 years. It maintains an efficacy rate of over 99% for each year of use. The safety profile of Kyleena is also favorable, with a lower risk of progestogen-related ovarian cysts compared to Mirena. However, it is contraindicated in women with known or suspected pelvic inflammatory disease (PID) or hypersensitivity to any component of the device[3][5].

Financial Performance

The financial trajectory of Kyleena is closely tied to the overall growth of the contraceptive devices market. With its FDA approval and subsequent market entry, Kyleena has contributed significantly to Bayer AG's revenue. The market's projected growth rate indicates that Kyleena will continue to be a lucrative product for Bayer AG.

Revenue Projections

Given the market's CAGR of 6.0%, it is expected that Kyleena will see steady revenue growth. The device's acceptance and listing on various healthcare reimbursement schedules, such as the PBS in Australia, further support its financial viability. As more women opt for long-acting reversible contraceptives, the demand for Kyleena is likely to increase, driving its revenue upward[4].

Market Penetration

Kyleena's market penetration is enhanced by its unique features, such as the low dose of levonorgestrel and the reduced risk of certain side effects. The device's ease of insertion and the single-handed loading mechanism also make it a preferred choice among healthcare providers. These factors contribute to its increasing market share and financial performance[2][5].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of Kyleena. Approvals from regulatory bodies like the FDA and listings on healthcare reimbursement schedules are critical for market access and revenue generation. The device's contraindications and safety profile are closely monitored by regulatory agencies, ensuring that it meets stringent safety standards[5].

Consumer Awareness and Preference

Consumer awareness and preference are key drivers of Kyleena's market dynamics. Surveys and clinical trials have shown that women are increasingly opting for non-daily contraception options like Kyleena due to its convenience and low hormone levels. This trend is expected to continue, driving demand and revenue for the product[3].

Clinical Trials and Research

Clinical trials have been instrumental in establishing Kyleena's efficacy and safety profile. These trials, involving over 1,400 women, have provided robust data on the device's performance over its 5-year lifespan. Ongoing research and clinical studies continue to support Kyleena's position in the market, addressing any emerging concerns and reinforcing its benefits[3][5].

Key Takeaways

• Market Growth: The global contraceptive devices market is projected to grow at a CAGR of 6.0%, driven by increasing awareness and government initiatives.
• Competitive Advantage: Kyleena offers a lower dose of levonorgestrel with fewer progestogen-related side effects compared to Mirena.
• Efficacy and Safety: Kyleena has high contraceptive efficacy and a favorable safety profile, with a lower risk of ovarian cysts.
• Financial Performance: Kyleena contributes significantly to Bayer AG's revenue, with steady growth expected due to market expansion and regulatory approvals.
• Regulatory Environment: Regulatory approvals and listings on healthcare reimbursement schedules are crucial for Kyleena's market access and revenue.

FAQs

Q: What is Kyleena, and how does it work? Kyleena is a progestogen-only, long-acting reversible contraceptive (LARC) intrauterine device (IUD) that contains 19.5 mg of levonorgestrel. It works by releasing a low dose of levonorgestrel over 5 years to prevent pregnancy.

Q: How effective is Kyleena in preventing pregnancy? Kyleena has a cumulative efficacy of 98.6% over 5 years, with an efficacy rate of over 99% for each year of use.

Q: What are the main differences between Kyleena and Mirena? Kyleena contains a lower dose of levonorgestrel (19.5 mg) compared to Mirena (52 mg), resulting in fewer progestogen-related side effects but a slightly higher risk of unplanned pregnancy.

Q: Is Kyleena contraindicated in any conditions? Yes, Kyleena is contraindicated in women with known or suspected pelvic inflammatory disease (PID) or hypersensitivity to any component of the device.

Q: How does the market size and growth of the contraceptive devices market impact Kyleena? The growing market size and projected CAGR of 6.0% indicate a favorable environment for Kyleena, with expected steady revenue growth and increasing market share.

Sources

1. GlobalData: Net Present Value Model: Mirena/Kyleena/Jaydess - GlobalData
2. NPS MedicineWise: Levonorgestrel (Kyleena) for contraception
3. KyleenaHCP: Kyleena ® Dosing and Efficacy
4. Fortune Business Insights: Contraceptive Devices Market Size, Share | Report [2032]
5. FDA: KYLEENA (levonorgestrel-releasing intrauterine system) Label[5]