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-three 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:	104
Patent Applications:	4,510
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
Israel	166787	DELIVERY SYSTEM AND MANUFACTURING PROCESS OF A DELIVERY SYSTEM
Norway	309406
Austria	235201
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)

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	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

SKYLA Market Analysis and Financial Projection Experimental

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

Introduction to Skyla

Skyla, a levonorgestrel-releasing intrauterine system (IUS), is a contraceptive device approved by the U.S. FDA for the prevention of pregnancy for up to three years. It is manufactured by Bayer HealthCare Pharmaceuticals Inc. and was introduced to the market in 2013[3].

Market Need and Demand

The approval of Skyla addresses a significant need in the contraceptive market. Nearly 50% of pregnancies in the U.S. are unintended, highlighting the demand for effective and long-term birth control options[3].

Competitive Landscape

Skyla enters a market dominated by other intrauterine devices, such as Mirena, also manufactured by Bayer. However, Skyla is distinguished by its smaller size and lower dose of levonorgestrel, making it an attractive option for women seeking a less invasive and lower-dose alternative[1][4].

Clinical Efficacy and Safety

The clinical efficacy of Skyla is supported by a Phase 3 trial involving 1,432 women aged 18-35. The trial demonstrated a low Pearl Index (PI) of 0.41 in the first year and a cumulative three-year PI of 0.33, indicating high contraceptive reliability[1][3].

Despite its efficacy, Skyla is associated with several adverse reactions, including vulvovaginitis, abdominal/pelvic pain, acne, and ovarian cysts. Serious adverse reactions such as ectopic pregnancy, pelvic inflammatory disease (PID), and perforation are also possible[3].

Pricing and Cost Considerations

The cost of Skyla is approximately $1,024 for a single device, which is a significant upfront expense for many patients. However, patient assistance programs and copay cards offered by Bayer can help mitigate these costs for eligible individuals[2].

Patient Assistance and Copay Programs

Bayer offers various patient assistance programs, including the Bayer US Patient Assistance Foundation Free Drug Program, which provides cost-free or discounted Skyla devices to individuals with no prescription coverage and a medically appropriate condition[2].

Market Penetration and Adoption

Since its approval, Skyla has been gaining traction in the market. The device's unique features, such as its smaller size and lower hormone dose, have made it an appealing option for women and healthcare providers. The expansion of Bayer's IUD portfolio with Skyla has also helped in increasing market share and customer loyalty[3].

Financial Trajectory

The financial performance of Skyla is closely tied to its market adoption and the overall demand for long-term contraceptive solutions. Here are some key financial aspects:

• Revenue Growth: With its introduction in 2013, Skyla has contributed to Bayer's revenue growth in the contraceptive segment. The device's popularity, especially among younger women and those seeking less invasive options, has driven sales.
• Cost-Benefit Analysis: While the initial cost of Skyla is high, the long-term benefits of a three-year contraceptive solution can be cost-effective compared to other birth control methods that require more frequent replacements or prescriptions.
• Insurance Coverage: Skyla is covered by many insurance plans, which helps in reducing the out-of-pocket costs for patients and increasing its accessibility. This coverage has been a significant factor in its market penetration[2].

Regulatory Environment

The regulatory environment has been supportive of Skyla's approval and continued use. The FDA's approval process, which included rigorous clinical trials, has ensured that Skyla meets high standards of safety and efficacy. Ongoing monitoring and updates to prescribing information also reflect the regulatory body's commitment to patient safety[1][4].

Future Outlook

The future outlook for Skyla is promising, driven by several factors:

• Increasing Demand for Long-Term Contraceptives: The need for effective and convenient birth control options is expected to continue, driving demand for devices like Skyla.
• Competitive Advantages: Skyla's unique features, such as its smaller size and lower hormone dose, position it well in a competitive market.
• Expanding Patient Assistance Programs: Continued support through patient assistance programs will help make Skyla more accessible to a broader range of patients.

Key Takeaways

• High Efficacy: Skyla has demonstrated a low Pearl Index, indicating high contraceptive reliability.
• Unique Features: Its smaller size and lower hormone dose differentiate it from other IUDs.
• Cost Considerations: While the initial cost is high, patient assistance programs and insurance coverage help reduce out-of-pocket expenses.
• Regulatory Support: FDA approval and ongoing regulatory monitoring ensure safety and efficacy.
• Future Growth: Increasing demand for long-term contraceptives and competitive advantages position Skyla for continued market success.

Frequently Asked Questions (FAQs)

Q1: How long does Skyla provide contraceptive protection? Skyla provides contraceptive protection for up to three years and must be removed or replaced after this period[4].

Q2: What are the common adverse reactions associated with Skyla? Common adverse reactions include vulvovaginitis, abdominal/pelvic pain, acne, and ovarian cysts. Serious reactions such as ectopic pregnancy and PID are also possible[3].

Q3: How much does Skyla cost? The cost of Skyla is approximately $1,024 for a single device, although patient assistance programs and copay cards can reduce this cost[2].

Q4: Is Skyla covered by insurance? Yes, Skyla is covered by many insurance plans, which helps reduce out-of-pocket costs for patients[2].

Q5: Can Skyla be removed at any time? Yes, Skyla can be removed by a healthcare provider at any time, and women can become pregnant shortly after its removal[3].

Cited Sources

1. FDA Document: Levonorgestrel-releasing-intrauterine-system-Skyla-PREA-clinical.pdf
2. Drugs.com: Skyla Prices, Coupons, Copay Cards & Patient Assistance
3. PR Newswire: U.S. FDA Approves Bayer's Skyla™ (Levonorgestrel-Releasing Intrauterine System) 13.5 mg
4. Drugs.com: Skyla IUD: Package Insert / Prescribing Information
5. Bayer Labeling: Skyla (levonorgestrel-releasing intrauterine system) - Bayer