TAVABOROLE - Generic Drug Details

What are the generic drug sources for tavaborole and what is the scope of patent protection?

Tavaborole is the generic ingredient in two branded drugs marketed by Anacor Pharms Inc, Alembic, Amneal, Chartwell Rx, Cipla, Encube, Lupin Ltd, Padagis Us, Taro, and Zydus Lifesciences, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tavaborole. Ten suppliers are listed for this compound.

Summary for TAVABOROLE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	316
Drug Prices:	Drug price trends for TAVABOROLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAVABOROLE
What excipients (inactive ingredients) are in TAVABOROLE?	TAVABOROLE excipients list
DailyMed Link:	TAVABOROLE at DailyMed

See drug prices for TAVABOROLE

Recent Clinical Trials for TAVABOROLE

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

Sponsor	Phase
Pfizer	Phase 4

See all TAVABOROLE clinical trials

Pharmacology for TAVABOROLE

Drug Class	Oxaborole Antifungal
Mechanism of Action	Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TAVABOROLE

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for TAVABOROLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KERYDIN	Topical Solution	tavaborole	5%	204427	13	2018-07-09

US Patents and Regulatory Information for TAVABOROLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211963-001	Feb 3, 2021	AB	RX	No	No
Cipla	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212224-001	Feb 9, 2021	AB	RX	No	No
Anacor Pharms Inc	KERYDIN	tavaborole	SOLUTION;TOPICAL	204427-001	Jul 7, 2014		DISCN	Yes	No
Lupin Ltd	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212168-001	Feb 8, 2021	AB	RX	No	No
Taro	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212215-001	May 7, 2021	AB	RX	No	No
Amneal	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212256-001	Nov 25, 2020	AB	RX	No	No
Encube	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211297-001	Oct 13, 2020	AB	RX	No	Yes

TAVABOROLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tavaborole

Introduction to Tavaborole

Tavaborole, marketed under the brand name Kerydin, is an oxaborole antifungal agent approved by the FDA for the treatment of onychomycosis, a fungal infection of the toenails and fingernails[5].

Global Market Size and Growth

The global tavaborole market is anticipated to grow at a moderate pace. It is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from its current valuation, reaching an estimated value by 2031[4].

Market Drivers

Several factors are driving the growth of the tavaborole market:

Increasing Incidence of Fungal Infections

The rising incidence of fungal infections, particularly onychomycosis, is a significant driver. Onychomycosis affects a substantial portion of the population, especially in older adults, creating a steady demand for effective treatments like tavaborole.

Technological Advancements

Advancements in topical drug delivery systems are enhancing the efficacy and user experience of tavaborole. These innovations improve the drug's penetration and absorption, making it more effective against fungal infections[3].

Preference for Topical Treatments

There is a growing preference for topical treatments over systemic antifungals due to their localized action and lower risk of systemic side effects. This trend is particularly strong in the dermatology sector, where tavaborole is primarily used[3].

Market Challenges

Despite the growth drivers, the tavaborole market faces several challenges:

Regulatory Obstacles

Stringent regulatory requirements regarding the safety and efficacy of topical medications can delay the commercialization of new formulations and limit innovation. These regulatory hurdles can impede market growth, especially for smaller companies with limited resources[3].

Competition from Alternative Drug Delivery Systems

The market for tavaborole is also competitive due to the presence of alternative drug delivery systems such as oral, injectable, and transdermal systems. In some cases, these alternatives may offer more reliable or effective outcomes, reducing the demand for topical treatments like tavaborole[3].

Financial Trajectory

Current Market Valuation

While specific current market valuations for tavaborole are not provided, the broader topical drug delivery market, within which tavaborole operates, was valued at USD 109.16 Billion in 2024. This market is expected to grow to USD 177.97 Billion by 2031, indicating a robust financial trajectory for the sector as a whole[3].

Revenue Projections

Given the expected CAGR of 3 to 5 percent for the tavaborole market, it is likely that the revenue from tavaborole will increase steadily over the forecast period. However, exact revenue projections for tavaborole specifically are not available in the current data.

Key Players and Market Share

The topical drug delivery market, which includes tavaborole, is dominated by several key players such as Hisamitsu Pharmaceuticals, Bayer AG, Novartis AG, and others. These companies invest heavily in research and development, which helps in maintaining and expanding their market share[3].

Regional Analysis

Geographical Dominance

North America holds a significant position in the topical drug delivery market, including tavaborole, due to its advanced healthcare infrastructure and substantial investments in research and development. Other high-growth regions include APAC and Europe, which are also expected to contribute significantly to the market's expansion[3].

Pharmacokinetics and Safety Profile

Understanding the pharmacokinetics and safety profile of tavaborole is crucial for its market dynamics. Tavaborole undergoes extensive metabolism, with renal excretion being the primary route of elimination for its metabolites. The drug has shown embryofetal toxicity in animal studies at high doses, but no such effects have been noted at the recommended human dose[2].

Clinical Policy and Approval

Tavaborole is approved for the treatment of onychomycosis and is subject to various clinical policies and approval criteria. For instance, continued therapy is approved if the member is responding positively to the treatment, and the dose does not exceed 10 mL (1 bottle) per claim[5].

Future Outlook

The future outlook for tavaborole is positive, driven by the increasing demand for localized treatment options and advancements in topical drug delivery systems. However, the market must navigate regulatory challenges and competition from other drug delivery methods to maintain its growth trajectory.

Key Takeaways

• The global tavaborole market is expected to grow at a CAGR of 3 to 5 percent.
• The market is driven by increasing incidence of fungal infections and technological advancements in topical drug delivery.
• Regulatory obstacles and competition from alternative drug delivery systems are significant challenges.
• North America dominates the market due to its advanced healthcare infrastructure.
• Tavaborole's pharmacokinetics and safety profile are critical for its clinical use.

FAQs

What is tavaborole used for?

Tavaborole is used for the treatment of onychomycosis, a fungal infection of the toenails and fingernails[5].

What are the potential side effects of tavaborole?

While tavaborole is generally well-tolerated, it can cause local irritation at the application site. In animal studies, high doses have shown embryofetal toxicity, but this is not observed at the recommended human dose[2].

How is tavaborole administered?

Tavaborole is administered topically as a 5% solution. It is applied directly to the affected nail and surrounding skin[2].

What are the key drivers of the tavaborole market?

The key drivers include the increasing incidence of fungal infections, technological advancements in topical drug delivery, and a preference for localized treatment options[3].

Who are the major players in the topical drug delivery market that includes tavaborole?

Major players include Hisamitsu Pharmaceuticals, Bayer AG, Novartis AG, Galderma Holding SA, and others[3].

Sources

1. Tavaborole Market 2024 Size Global Industry Analysis by Trends ... - Northeast News Channel Nebraska
2. TAVABOROLE solution - DailyMed - DailyMed
3. Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031 Globally at 6.3% CAGR - GlobeNewswire
4. Global Tavaborole Market Size And Forecast - Market Research Intellect
5. Clinical Policy: Tavaborole (Kerydin) - Superior HealthPlan