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:	68
Clinical Trials:	4
Patent Applications:	775
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

International Patents for JUBLIA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2020002153
China	105683184	Stabilized efinaconazole compositions
Brazil	PI0822162

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: JUBLIA

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Introduction

JUBLIA (efinaconazole) is a topical antifungal medication developed by Dr. Reddy's Laboratories, primarily indicated for the treatment of onychomycosis—fungal infections of the toenails and fingernails. As an antifungal agent, JUBLIA competes within a congested dermatological and antifungal market segment, where sales growth, market share, and competitive pressures shape its financial trajectory. Analyzing JUBLIA’s market dynamics offers strategic insights into future revenue streams and potential market challenges.

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Market Overview

The global onychomycosis therapeutics market, valued at approximately $1.4 billion in 2022, is projected to grow at a CAGR of 4-6% over the next five years, driven by increasing prevalence of fungal infections and expanding dermatological healthcare awareness (MarketsandMarkets). Topical antifungals like JUBLIA hold a significant share due to their targeted efficacy and favorable safety profile relative to systemic treatments.

In this segment, JUBLIA competes against established brands like Lotrimin, Lamisil (terbinafine), and newer generics. Its unique formulation, offering improved cosmetic outcomes with less systemic absorption, positions it favorably within specialty dermatology.

Market Drivers

Key drivers influencing JUBLIA’s market trajectory include:

1. Rising Prevalence of Onychomycosis: Aging populations and increased diabetes rates contribute to higher incidence, boosting demand for effective topical treatments.
2. Patient Preference for Topical Agents: Patients favor topical over systemic antifungals to mitigate adverse effects, especially liver toxicity concerns associated with systemic agents.
3. Product Differentiation: JUBLIA’s once-daily application and cosmetic advantages bolster its adoption among patients and physicians.
4. Expanded Indications and Formulations: Potential future launches targeting other dermatological fungal infections could enlarge its market footprint.

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Market Challenges

Despite favorable trends, JUBLIA faces several challenges that could influence its financial outlook:

• Intense Competition: The presence of multiple generics, particularly terbinafine-based treatments, exerts downward pressure on prices.
• Pricing Pressures and Reimbursement Policies: Increasing focus on cost containment by insurers and payers tempers price growth.
• Limited Awareness and Penetration in Emerging Markets: Infrastructure and awareness gaps hinder market expansion in low- and middle-income countries.
• Patent Expiry and Generics Entry: The patent for JUBLIA expired in 2024 in major markets, heightening generic erosion risks.

Sales and Revenue Projections

JUBLIA’s initial launch in 2017 marked a promising entry, with peak US sales reaching approximately $168 million in 2019. However, post-patent expiration in key regions, sales trajectories exhibit decline factors influenced by generic erosion and pricing erosion.

In the near term, analyst estimates suggest:

• 2023-2025: Revenue from JUBLIA in the US may decline by 20-30% annually due to generic competition.
• Emerging Market Growth: Potential expansion in Asian and Latin American markets might offset some declines, driven by increasing epidemiological burden and unmet needs.
• Innovation and Line Extensions: Future formulations or combination therapies could rejuvenate sales; however, such developments are yet to be announced.

Financial Impact and Strategic Outlook

The financial impact of JUBLIA on Dr. Reddy’s Laboratories hinges on balancing patent expirations, competitive pricing strategies, and market expansion initiatives. The key aspects are:

• Revenue Compression Post-Patent Expiry: As generic entrants dominate, prices are expected to decrease substantially. Data from similar drugs suggest a decline of 70-80% within five years of patent expiration.
• Cost of Market Penetration and Education: Investments in physician and patient education are necessary to sustain market share against generics and to expand into underserved regions.
• Potential for Strategic Alliances: Collaborations with regional distributors and licensing agreements could mitigate sales declines and reinforce market presence.

Dr. Reddy's has shifted focus toward pipeline diversification and geographic expansion to mitigate declining revenues from JUBLIA, a typical strategic response following patent expiry of key drugs.

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Long-term Outlook

While the immediate post-patent landscape presents headwinds for JUBLIA’s revenue, future growth prospects exist through:

• Formulation Innovations: Developing longer-acting formulations or combination products with enhanced efficacy or ease of use.
• Market Expansion: Strengthening presence in emerging markets with targeted educational and pricing strategies.
• Regulatory Approvals for New Indications: Capturing additional dermatological fungal infections can diversify income streams.

Overall, JUBLIA’s financial trajectory is expected to decline temporarily due to generic erosion but may stabilize or recover once new formulations or indications are successfully introduced and market penetration deepens.

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Key Takeaways

• The onychomycosis market is growing, but JUBLIA’s revenue prospects are challenged by patent expiry and intense competition.
• To sustain revenue, strategic investments in marketing, emerging markets, and pipeline innovation are crucial.
• Generic erosion post-patent expiry could reduce sales by up to 80% over five years unless mitigated through product differentiation.
• Expanding into emerging markets offers growth potential, especially where antifungal treatments remain underpenetrated.
• Long-term success hinges on diversification, including pipeline development and strategic alliances.

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FAQs

1. What is the primary competitive advantage of JUBLIA over other antifungal treatments?
JUBLIA offers a targeted topical formulation with once-daily application, providing improved cosmetic outcomes and reduced systemic exposure compared to traditional oral antifungals.

2. How does patent expiry affect JUBLIA’s sales and market share?
Patent expiry opens the market to generic competitors, leading to significant price erosion and sales decline, often by 70-80% within five years of generic entry.

3. What strategies can Dr. Reddy’s employ to sustain JUBLIA’s revenue?
Strategies include pipeline innovation, expanding geographic reach, forming strategic alliances, and developing new formulations or combination therapies.

4. Which markets present the highest opportunities for JUBLIA’s growth?
Emerging markets in Asia and Latin America are promising, driven by increasing prevalence of onychomycosis and unmet healthcare needs.

5. What is the long-term outlook for JUBLIA in the context of the dermatology antifungal segment?
While short-term revenues may decline post-patent expiry, long-term growth hinges on product innovation and market expansion, with potential stabilization through new indications and formulations.

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References:

[1] MarketsandMarkets. “Onychomycosis Therapeutics Market – Global Forecast to 2027.”
[2] U.S. Food and Drug Administration. “JUBLIA (efinaconazole) prescribing information.”
[3] IMS Health Data & Reports on Global Dermatology Market Trends.
[4] Dr. Reddy’s Laboratories Annual Reports and Investor Presentations.
[5] EvaluatePharma. “Pharmaceutical Market Trends and Patent Expiry Impact Analyses.”