JUBLIA Drug Patent Profile

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

Jublia is a drug marketed by Bausch and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-five patent family members in twenty-four countries.

The generic ingredient in JUBLIA is efinaconazole. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jublia

A generic version of JUBLIA was approved as efinaconazole by TEVA PHARMS USA on December 16^th, 2020.

Summary for JUBLIA

International Patents:	85
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	4
Patent Applications:	271
Drug Prices:	Drug price information for JUBLIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JUBLIA
What excipients (inactive ingredients) are in JUBLIA?	JUBLIA excipients list
DailyMed Link:	JUBLIA at DailyMed

See drug prices for JUBLIA

Recent Clinical Trials for JUBLIA

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

Sponsor	Phase
Dong-A ST Co., Ltd.	Phase 4
University of Alabama at Birmingham	Phase 4
University of Alabama at Birmingham	N/A

See all JUBLIA clinical trials

Pharmacology for JUBLIA

Drug Class

Azole Antifungal

Paragraph IV (Patent) Challenges for JUBLIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JUBLIA	Topical Solution	efinaconazole	10%	203567	19	2018-06-06

US Patents and Regulatory Information for JUBLIA

JUBLIA is protected by eighteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	7,214,506
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	9,302,009		Y
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	11,654,139
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	10,512,640
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	8,039,494
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	11,213,519

International Patents for JUBLIA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20100108555	COMPOSITIONS AND METHODS FOR TREATING DISEASES OF THE NAIL
Malaysia	179756	STABILIZED EFINACONAZOLE FORMULATIONS
Denmark	2730310
World Intellectual Property Organization (WIPO)	2015051183
South Korea	101938434
Japan	2010004893	METHOD FOR DETECTING PATHOGENIC MICROORGANISM AND ANTIMICROBIAL AGENT, METHOD FOR EVALUATING EFFECT OF ANTIMICROBIAL AGENT, AND ANTIMICROBIAL AGENT

Market Dynamics and Financial Trajectory for Jublia

Market Growth and Projections

The dermatophytic onychomycosis treatment market, in which Jublia is a key player, is poised for significant growth. The global market is expected to expand from USD 4.44 billion in 2022 to USD 9.801 billion by 2032, at a Compound Annual Growth Rate (CAGR) of 8.46%[1].

Product Performance and Revenue

Jublia, a topical antifungal solution developed by Bausch Health, has been a driving force in the market. In 2019, Jublia generated a total revenue of USD 110 million, with a cure rate of 15-18%, which is higher than other nail lacquers[1].

Market Segmentation and Dominance

The market is segmented into nail paints and tablets based on product type. The nail paints segment, led by Jublia, is expected to dominate the market during the forecast period due to increasing adoption and preference for topical treatments over oral antifungal drugs[1][4].

Route of Administration

The topical segment, which includes Jublia, held the largest market share in 2022. This segment is expected to continue growing due to significant investment in research and development (R&D) for advanced topical medications. However, oral medications, such as terbinafine and griseofulvin, are also gaining traction due to their higher efficacy and government efforts to switch to generic drugs[1][4].

Regional Market Performance

North America, particularly the U.S., is the largest market for dermatophytic onychomycosis treatments, driven by increasing prescriptions for onychomycosis, rising research, and high demand for Jublia and Kerydin. The region's market was valued at USD 2.20 billion in 2023 and is expected to continue growing[4].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the market. While it led to a decline in sales of nail paints, especially in Japan, it also accelerated the shift towards topical treatments and generic drugs, which could benefit Jublia in the long term[1][4].

Competitive Landscape

Bausch Health, the manufacturer of Jublia, held the largest market share in the dermatophytic onychomycosis treatment market. However, the company's market share is expected to decrease due to the loss of Jublia's patent and the economic impact of the COVID-19 pandemic. Pfizer, with its product Kerydin, ranks second in the market[1].

Generic Competition

Acrux Limited is developing a generic version of Jublia, which was accepted for review by the FDA in 2018. If approved, this generic version is expected to gain significant market share, potentially up to 50% within the 180-day exclusivity period. This development could impact Jublia's market dominance[3].

Financial Performance of Bausch Health

Bausch Health's financial performance is closely tied to the success of Jublia. In the third quarter of 2023, Bausch Health reported a total revenue of USD 2.238 billion, with a 9% increase compared to the same period in 2022. The pharmaceutical segment, which includes Jublia, saw a modest increase in revenue, reflecting the ongoing demand for the product[2].

Reimbursement and Regulatory Approvals

Jublia's favorable reimbursement status has contributed to its market success. Regulatory approvals, such as the supplemental new drug application approved by the U.S. FDA in April 2020, further enhance its market position[4].

R&D and Innovation

Investment in R&D for advanced treatments is a key driver for the market. Bausch Health's continued investment in developing new and improved treatments, including topical solutions like Jublia, is expected to drive market demand and growth[1].

Government Awareness and Initiatives

Government campaigns and initiatives to raise awareness about dermatophytic onychomycosis have contributed to regional market development. These efforts have helped increase the adoption of treatments like Jublia, particularly in regions like North America and Europe[1].

Key Takeaways

• Market Growth: The dermatophytic onychomycosis treatment market is expected to grow at a CAGR of 8.46% from 2022 to 2032.
• Product Dominance: Jublia dominates the nail paints segment and is expected to continue leading the market.
• Regional Performance: North America is the largest market, driven by high demand and research activities.
• Generic Competition: The emergence of generic versions of Jublia could impact its market share.
• Financial Performance: Bausch Health's revenue is influenced by Jublia's success, with ongoing R&D and favorable reimbursement contributing to its market position.

FAQs

Q: What is the projected market size for dermatophytic onychomycosis treatments by 2032? A: The global market is expected to reach USD 9.801 billion by 2032[1].

Q: What is the cure rate of Jublia compared to other nail lacquers? A: Jublia has a cure rate of 15-18%, which is higher than other nail lacquers[1].

Q: How has the COVID-19 pandemic affected the sales of Jublia? A: The pandemic led to a decline in sales of nail paints, especially in Japan, but it also accelerated the shift towards topical treatments[1][4].

Q: Who are the major competitors in the dermatophytic onychomycosis treatment market? A: Bausch Health and Pfizer are the key players, with Bausch Health holding the largest market share due to Jublia[1].

Q: What is the impact of generic versions of Jublia on its market share? A: Generic versions, such as the one developed by Acrux, could significantly reduce Jublia's market share, potentially up to 50% within the exclusivity period[3].

Sources

1. Market.us: Dermatophytic Onychomycosis Treatment Market CAGR Of 8.46%
2. Bausch Health: Q3 2023 Earnings Presentation
3. Acrux Limited: Investor Presentation
4. Fortune Business Insights: Dermatophytic Onychomycosis Treatment Market Size [2032]