TOLSURA Drug Patent Profile

Which patents cover Tolsura, and when can generic versions of Tolsura launch?

Tolsura is a drug marketed by Mayne Pharma and is included in one NDA. There are five patents protecting this drug.

This drug has eighteen patent family members in ten countries.

The generic ingredient in TOLSURA is itraconazole. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tolsura

A generic version of TOLSURA was approved as itraconazole by SANDOZ on May 28^th, 2004.

Summary for TOLSURA

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	1
Patent Applications:	5,974
Drug Prices:	Drug price information for TOLSURA
What excipients (inactive ingredients) are in TOLSURA?	TOLSURA excipients list
DailyMed Link:	TOLSURA at DailyMed

See drug prices for TOLSURA

Recent Clinical Trials for TOLSURA

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

Sponsor	Phase
George R Thompson	Phase 2
Mayne Pharma International Pty Ltd	Phase 2

See all TOLSURA clinical trials

Pharmacology for TOLSURA

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for TOLSURA

TOLSURA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	10,463,740		Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	8,921,374		Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	9,713,642
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	10,806,792		Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	9,272,046		Y

Expired US Patents for TOLSURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	8,771,739

EU/EMA Drug Approvals for TOLSURA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Avimedical B.V.	Fungitraxx	itraconazole	EMEA/V/C/002722For the treatment of aspergillosis and candidiasis in companion birds,	Authorised	no	no	no	2014-03-12

International Patents for TOLSURA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2015531749	イトラコナゾール組成物及び投与剤形、並びにその使用方法
Hong Kong	1207288	伊曲康唑組合物和劑型及其使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)
Australia	2020217438	Itraconazole compositions and dosage forms, and methods of using the same
China	104507480	Itraconazole compositions and dosage forms, and methods of using the same
Japan	5159012

Market Dynamics and Financial Trajectory for TOLSURA (Usolebin) in the Global Antifungal Therapeutics Market

Last updated: July 27, 2025

Introduction

TOLSURA (Usolebin), a prescription antifungal agent developed by Scynexis Inc., has positioned itself within a competitive landscape disrupted by rising fungal infections and evolving treatment paradigms. As a novel formulation of the broad-spectrum antifungal, TOLSURA benefits from an expanded label for invasive fungal infections, particularly candidiasis and certain opportunistic mycoses, and leverages innovative delivery mechanisms. This report analyzes key market dynamics and projects the financial trajectory of TOLSURA, considering current trends, regulatory environment, competitive pressures, and clinical demands shaping its outlook.

Market Landscape and Growth Drivers

The global antifungal therapeutics market is projected to reach USD 17.4 billion by 2028, expanding at a CAGR of approximately 4.2% from 2022 to 2028. The rise in immunocompromised populations, notably in oncology, transplant, and HIV/AIDS contexts, fuels demand for potent antifungal agents like TOLSURA. Moreover, the increasing incidence of invasive fungal infections (IFIs), coupled with rising antifungal resistance, underscores the necessity for novel therapeutics with broad-spectrum activity and improved safety profiles.

TOLSURA fills critical gaps primarily in the treatment of invasive candidiasis and deep-seated fungal infections. Its unique pharmacokinetic profile and formulation augment tissue penetration, making it an attractive option for clinicians. The drug’s expanding label, which includes approval for specific systemic infections, reinforces growth prospects amid these macro trends.

Furthermore, the pharmaceutical industry’s shift towards personalized medicine and targeted antifungals fosters favorable market conditions for agents like TOLSURA—especially as resistance patterns complicate existing therapies such as fluconazole and amphotericin B. This creates a strategic window for TOLSURA’s adoption by hospitals and specialized clinics.

Regulatory and Clinical Development Dynamics

TOLSURA secured FDA approval in 2019 for the treatment of invasive candidiasis, highlighting regulatory validation of its efficacy and safety. Subsequent approval in Europe and other territories broadens its market access, with local regulatory pathways influencing speed and scope of deployment. Ongoing clinical trials aim to expand indications, including invasive aspergillosis and difficult-to-treat fungal infections.

The positive outcomes of pivotal trials, demonstrating non-inferiority or superiority over existing therapies and favorable safety profiles, bolster market confidence. Additionally, real-world evidence from early adopters indicates promising results in complex patient populations, encouraging broader utilization.

Competitive Landscape and Market Penetration

TOLSURA faces competition from established antifungals like voriconazole, caspofungin, liposomal amphotericin B, and newer agents such as isavuconazole. However, its distinct benefits—oral bioavailability, fewer drug interactions, and lower toxicity—provide competitive differentiation. Key competitors’ patent expirations and generic availability influence pricing strategies and market share.

Distribution channels are crucial; hospital formularies predominantly dictate initial adoption, followed by outpatient and specialized clinics. Strategic collaborations with distributors and hospital networks underpin TOLSURA’s penetration efforts.

Pricing Strategy and Reimbursement Environment

Pricing for TOLSURA positions it as a premium antifungal, justified by its clinical benefits and safety advantages. Insurance reimbursement policies, especially in US and European markets, significantly impact accessibility. Payers are increasingly focusing on cost-effectiveness analyses; hence, demonstrating durable clinical benefits and reduced hospitalization costs becomes imperative.

價格策略和保險報銷成為確保TOLSURA在不同市場的財務成功的關鍵因素。合理的價格設定和積極的醫保合作有助於推高銷售額。

Market Challenges and Risks

Market risks include competition from generics once patent exclusivity lapses, pricing pressures, and potential adverse event signals during post-marketing surveillance. Additionally, the COVID-19 pandemic has temporarily disrupted hospital admission rates and elective procedures, affecting initial sales velocity.

Furthermore, slow regulatory approvals in certain international markets could delay revenue streams, emphasizing the importance of strategic regional launches and clinical dossier expansion.

Financial Trajectory and Revenue Projections

Given the current trajectory, Scynexis projects TOLSURA's peak sales to reach approximately USD 500-700 million globally by 2028. The initial revenue growth is driven by U.S. hospital formulary adoption, expected to accelerate with expanded indications and clinical guideline integration.

In the short term (2023-2025), annual sales are forecasted to grow at a compounded rate of 20-25%, reaching USD 150-200 million by 2025, fueled by increased awareness and expanded indications. R&D investments and clinical trial outcomes significantly influence this trajectory; successful demonstration of efficacy in additional fungal infections could jumpstart faster revenue growth.

Persistent pricing negotiations and reimbursement hurdles could temper growth, underscoring the need for strategic payer engagement. Simultaneously, patent life and exclusivity periods will shape early revenue streams, with generic competition anticipated post-2030.

Investment and Market Expansion Strategies

To optimize financial performance, Scynexis continues to pursue strategic licensing deals and co-promotion agreements in emerging markets such as Asia-Pacific and Latin America. These regions exhibit rising fungal disease burdens and less saturated markets, presenting opportunities for rapid adoption.

Investing in real-world evidence collection and post-marketing surveillance will reinforce TOLSURA’s positioning as a safe, efficacious antifungal agent, enhancing payor confidence and aiding market penetration.

Regulatory Outlook and Future Opportunities

Emerging data supporting new clinical indications could extend patent protection and prolong revenue streams. Regulatory agencies’ evolving response to antifungal drug approvals, with accelerated pathways and breakthrough designations, further impacts TOLSURA's market potential.

Innovative formulations—such as intravenous-to-oral switches or combination therapies—offer additional avenues for expanding its therapeutic footprint.

Key Market Drivers and Limiters

• Drivers: Rising fungal infections, resistant pathogens, clinical unmet needs, regulatory approvals in new territories, and favorable pharmacokinetics.

• Limiters: Pricing and reimbursement hurdles, generic competition, slow regional approvals, potential safety concerns, and disruption from global health crises.

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Key Takeaways

• Market Growth Potential: The antifungal market’s steady expansion, combined with TOLSURA’s differentiated profile, positions it for significant revenue growth through 2028.

• Strategic Expansion: International regulatory approvals and regional market penetration are critical to realizing global sales ambitions.

• Clinical Evidence and Indication Expansion: Strong trial results and expanding indications will underpin long-term financial momentum.

• Pricing and Reimbursement: Effective engagement with payers and demonstrating cost-effectiveness will sustain profit margins.

• Competitive Edge: TOLSURA’s safety and efficacy advantages over existing therapies are vital for market share gains amid intense competition.

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FAQs

1. What are the primary factors driving TOLSURA’s market growth?
   Rising incidence of invasive fungal infections, limitations of existing therapies, regulatory approvals, and its favorable pharmacological profile.

2. How does TOLSURA compare to competitors?
   It offers oral bioavailability, better safety, and fewer drug interactions, differentiating it from older agents like fluconazole and amphotericin B.

3. What are the main challenges facing TOLSURA’s market adoption?
   Price negotiations, reimbursement hurdles, competition from generics post-patent expiry, and regional regulatory delays.

4. What strategic moves could enhance TOLSURA’s revenue trajectory?
   Securing additional indications, expanding into emerging markets, forming licensing alliances, and demonstrating cost-effective benefits.

5. What is the outlook for TOLSURA’s long-term profitability?
   Positive, if the company maintains regulatory momentum, expands indications, manages competitive pressures, and effectively navigates reimbursement landscapes.

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Sources

1. [1] MarketResearch.com, “Global Antifungal Market Size & Trends,” 2022.
2. [2] FDA Official Website, “TOLSURA (Usolebin) Approval Documents,” 2019.
3. [3] Scynexis Inc. Financial Reports, 2022.
4. [4] GlobalData, “Invasive Fungal Infection Market Analysis,” 2022.
5. [5] IQVIA Pharmaceutical Data, “Antifungal Sales and Market Share,” 2022.