ulesfia Drug Patent Profile

When do Ulesfia patents expire, and what generic alternatives are available?

Ulesfia is a drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in ULESFIA is benzyl alcohol. There are fifty drug master file entries for this compound. Additional details are available on the benzyl alcohol profile page.

DrugPatentWatch^® Generic Entry Outlook for Ulesfia

Ulesfia was eligible for patent challenges on April 9, 2013.

There have been two 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.

Indicators of Generic Entry

Summary for ulesfia

US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	221
Clinical Trials:	1
Patent Applications:	3,885
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ulesfia
What excipients (inactive ingredients) are in ulesfia?	ulesfia excipients list
DailyMed Link:	ulesfia at DailyMed

See drug sales revenues for ulesfia

Recent Clinical Trials for ulesfia

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

Sponsor	Phase
Akorn, Inc.	Phase 3
South Florida Family Health and Research Centers	Phase 3
Axis Clinical Trials	Phase 3

See all ulesfia clinical trials

Paragraph IV (Patent) Challenges for ULESFIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULESFIA	Lotion	benzyl alcohol	5%	022129	1	2016-04-11

US Patents and Regulatory Information for ulesfia

ulesfia is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009		DISCN	Yes	No	7,294,342

Expired US Patents for ulesfia

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	5,858,383
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	7,294,342
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	6,139,859
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	6,793,931

Ulesfia Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ulesfia

Introduction to Ulesfia

Ulesfia, also known as benzyl alcohol lotion 5%, is an FDA-approved prescription treatment for head lice infestations. It is particularly notable for its non-neurotoxic formulation and effectiveness in treating head lice, especially in cases where resistance to other treatments has developed.

Market Need and Demand

Head lice are a widespread problem, affecting over 100 million people globally each year, with up to 12 million cases in the United States alone. The majority of those affected are children between the ages of 3 and 11. The social stigma and frequent misdiagnosis of head lice infestations create a significant demand for effective and safe treatments[1].

Competitive Landscape

The market for head lice treatments is dominated by over-the-counter (OTC) products, many of which contain permethrin or malathion. However, resistance to these agents has been increasing, making Ulesfia a valuable alternative. Ulesfia's mechanism of action, which involves suffocating the lice by disabling their breathing structure (spiracle), sets it apart from neurotoxic pediculicides[1][4].

Clinical Evidence and Efficacy

Ulesfia has been tested in several clinical trials, including two Phase III studies involving 628 patients. These studies demonstrated that Ulesfia is safe and effective, with 76.2% and 75.0% of patients being lice-free 14 days after the second application, compared to 4.8% and 26.2% for the vehicle control group[1][4].

Regulatory Approval and Availability

Ulesfia was approved by the FDA in July 2009 for the treatment of head lice infestations in patients 6 months of age and older. This approval marked a significant milestone, as Ulesfia is the first FDA-approved non-neurotoxic lice treatment available in the United States[1].

Safety Profile

Ulesfia is distinguished by its non-neurotoxic formulation, which reduces the risk of adverse effects associated with other pediculicides. Clinical trials have shown that Ulesfia is safe for use in children as young as 6 months, making it a preferred option for pediatric patients[1][4].

Market Penetration and Adoption

Despite its efficacy and safety, Ulesfia faces challenges in market penetration due to the prevalence of OTC treatments and the reluctance of patients to seek prescription medications for head lice. However, the growing resistance to OTC agents and the increasing awareness of Ulesfia's benefits are expected to drive adoption[1].

Financial Trajectory

Initial Market Impact

Upon its approval, Ulesfia was expected to capture a significant share of the prescription head lice treatment market. The drug's unique mechanism of action and safety profile positioned it as a valuable alternative to existing treatments.

Revenue Projections

While specific revenue figures for Ulesfia are not publicly disclosed, the overall market for head lice treatments is substantial. Given the high efficacy and safety of Ulesfia, it is likely to generate significant revenue, particularly as resistance to other treatments continues to rise.

Competitive Pricing

Ulesfia's pricing strategy is critical in its market positioning. As a prescription drug, it may be more expensive than OTC options, but its effectiveness and safety justify the cost. The pricing is also influenced by the cost of other prescription treatments and the willingness of insurance companies to cover the drug.

Future Outlook

Market Growth

The demand for effective head lice treatments is expected to remain strong, driven by the ongoing issue of resistance to OTC agents. Ulesfia's position as a non-neurotoxic and effective treatment places it in a favorable position for market growth.

Potential Expansion

There is potential for Ulesfia to be used in other settings beyond the United States, particularly in regions where head lice infestations are common and resistance to other treatments is a significant issue.

Key Takeaways

• Unique Mechanism of Action: Ulesfia works by suffocating head lice, making it an effective alternative to neurotoxic pediculicides.
• Clinical Efficacy: Ulesfia has demonstrated high efficacy in clinical trials, with a significant percentage of patients becoming lice-free after treatment.
• Safety Profile: The non-neurotoxic formulation of Ulesfia makes it safe for use in children as young as 6 months.
• Market Positioning: Ulesfia is well-positioned to capture a significant share of the prescription head lice treatment market due to its efficacy and safety.
• Future Outlook: The drug is expected to see continued market growth driven by the need for effective and safe head lice treatments.

FAQs

What is Ulesfia and how does it work?

Ulesfia is a benzyl alcohol lotion 5% used for the treatment of head lice. It works by disabling the breathing structure (spiracle) of the lice, leading to their suffocation.

Is Ulesfia safe for children?

Yes, Ulesfia is safe for use in children as young as 6 months of age. It is a non-neurotoxic formulation, reducing the risk of adverse effects associated with other pediculicides.

How effective is Ulesfia in treating head lice?

Ulesfia has been shown to be highly effective in clinical trials, with 76.2% and 75.0% of patients becoming lice-free 14 days after the second application.

Why is Ulesfia preferred over OTC treatments?

Ulesfia is preferred due to its non-neurotoxic formulation and its effectiveness in treating head lice, especially in cases where resistance to OTC agents has developed.

Is Ulesfia covered by insurance?

The coverage of Ulesfia by insurance companies varies, but its effectiveness and safety profile often justify its inclusion in insurance plans.

Sources

1. Pharmacy Times: "Exploring a Prescription Option for the Treatment of Head Lice"
2. Bloom Burton: "Research Initiation – Healthcare Sector Overview"
3. Baron Capital Group: "A Multi-Billion-Dollar Drug Market"
4. PubMed: "The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia)"
5. BioExec Institute: "The World's Health Care Crisis"