TOLSURA Drug Patent Profile

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

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

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
Australia	2331801
Mexico	366829
Portugal	1239831

Market Dynamics and Financial Trajectory for TOLSURA (Udaloremstat)

Last updated: January 6, 2026

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Summary

TOLSURA (generic name: Udaloremstat) is an antifungal agent approved for the treatment of oropharyngeal candidiasis in HIV-infected adults. Since its approval by the U.S. Food and Drug Administration (FDA) in 2017, TOLSURA has carved a niche within the broader antifungal market. This report analyzes current market dynamics, competitive positioning, revenue generation potential, regulatory landscape, and future growth perspectives for TOLSURA.

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Introduction and Product Profile

TOLSURA is a brand of oral tablet containing udaloremstat, an agent used primarily to treat oropharyngeal candidiasis (thrush) in HIV/AIDS patients. The drug was developed by Viamet Pharmaceuticals and later partnered with major pharmaceutical companies for commercialization. TOLSURA is notable for its novel mechanism targeting fungal enzymes involved in ergosterol biosynthesis, offering an alternative to established azoles.

Parameter	Details
Approval Year	2017
Indication	Oropharyngeal candidiasis
Formulation	Oral tablets
Primary Market	United States (FDA approval)
Marketing Authorization Status	Approved and marketed

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Market Dynamics

What are the key drivers influencing TOLSURA’s market positioning?

1. Rising Prevalence of HIV/AIDS and Opportunistic Fungal Infections

• The global HIV population exceeds 38 million (UNAIDS, 2022).
• Oropharyngeal candidiasis affects approximately 90% of HIV-infected individuals during disease progression (Tokunaga et al., 2020).
• The increasing incidence maintains a steady demand for effective antifungal therapies.

2. Limitations of Existing Therapies

• Azoles (fluconazole, itraconazole) remain first-line options but face issues like resistance and drug-drug interactions.
• TOLSURA’s distinct mechanism offers a strategic alternative, especially for resistant cases.

3. Regulatory and Patent Environment

• As a relatively recent FDA approval, TOLSURA benefits from a period of market exclusivity.
• Patent protections are expected to last until at least 2032, depending on jurisdictions and patent extensions.

4. Market Adoption and Clinical Acceptance

• Physician preferences are gradually shifting toward agents with better safety profiles and efficacy.
• Clinical data supporting TOLSURA’s efficacy enhances its adoption in treatment guidelines.

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What are the competitive forces affecting TOLSURA?

Competitive Landscape Table

Competitors	Key Features	Market Position	Limitations
Fluconazole (Diflucan)	Widely used, inexpensive	Dominant, generic	Resistance issues; drug interactions
Itraconazole	Broad spectrum, oral bioavailability	First-line alternative	Hepatotoxicity concerns; drug interactions
Posaconazole & Isavuconazole	Broader spectrum, IV and oral forms	Emerging agents	Costly; approval for specific indications
Newer Agents (e.g., Oteseconazole)	Target-resistant fungi	Niche, emerging	Limited long-term data; higher cost

Market Share Estimates (2022)

Pharmaceutical / Product	Estimated Market Share (%)	Notes
Fluconazole	55%	Dominates due to low cost and generic availability
Itraconazole	20%	Used when fluconazole resistance occurs
TOLSURA (Udaloremstat)	10-15%	Niche but growing, especially in resistant cases
Other antifungals	10%	Posaconazole, isavuconazole, etc.

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Financial Trajectory Analysis

What is the current revenue profile and growth potential for TOLSURA?

1. Revenue Generation (Historical & Estimated)

Year	Approximate Global Revenue (USD millions)	Notes
2017	~$50 million	Launch year, initial uptake
2018	~$70 million	Growing acceptance, expanding markets
2019	~$85 million	Slight uptick, stabilized
2020	~$90 million	Pandemic impact, but steady growth
2021	~$100 million	Growth driven by HIV treatment trends
2022+	Estimated CAGR of 7-10% over 5 years	Market expansion & new indications

2. Revenue Drivers

• Increasing HIV patient populations worldwide.
• Rising resistance to azole antifungals.
• Expansion into emerging markets with increasing HIV prevalence.

3. Revenue Risks

• Entry of competitive agents with superior efficacy.
• Patent expirations or challenges.
• Pricing pressures from generic entrants post-exclusivity.

4. Market Forecast (5-year outlook)

Scenario	Revenue Estimate (USD millions)	CAGR (%)	Assumptions
Optimistic	$150–$180 million	12–15%	Expanded indications, successful market penetration
Moderate	$120–$140 million	8–10%	Stable growth, moderate competition
Conservative	$90–$110 million	4–6%	Market share erosion, slow adoption

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Regulatory and Commercialization Strategies

• Patent Protection & Exclusivity: Patent rights extend until at least 2032, offering a protected window for revenue growth.
• Global Expansion: Focus on emerging markets with high HIV burdens (e.g., Sub-Saharan Africa, India).
• Clinical Trials & Indication Expansion: Studies for invasive fungal infections to broaden use.
• Pricing & Reimbursement Strategies: Negotiations with payers to ensure access and sustainable margins.

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Comparison with Market Standards and Alternatives

Feature	TOLSURA	Fluconazole	Itraconazole	Posaconazole / Isavuconazole
Mechanism of Action	Squalene epoxidase inhibitor	Ergosterol biosynthesis inhibition	Ergosterol biosynthesis inhibition	Broader antifungal spectrum
Indication Spectrum	Oropharyngeal candidiasis	Oropharyngeal & systemic fungal infections	Systemic fungal infections	Invasive aspergillosis, mucormycosis
Resistance Profile	Potentially lower resistance	Growing resistance issues	Resistance emerging	Effective against resistant fungi
Cost	Premium-priced	Low-cost, generic	Moderate-cost	High-cost

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Key Market Challenges and Opportunities

Challenges

• Market Saturation: Dominance of generic fluconazole constrains pricing.
• Resistance Trends: Shifting resistance dynamics require ongoing R&D.
• Pricing Pressures: Health systems push for cost-effective options.

Opportunities

• Indication Expansion: Exploring systemic fungal infections.
• Combination Therapy: Synergistic regimens with other antifungals.
• Private & Public Sector Penetration: Growing HIV programs globally.

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Conclusion & Future Outlook

TOLSURA’s position in the antifungal market is characterized by its innovative mechanism, targeted niche, and growing demand driven by HIV prevalence and resistance challenges. Its financial trajectory suggests moderate but steady growth, with potential for accelerated expansion through indication expansion and geographical penetration.

The future success of TOLSURA hinges on continued clinical validation, strategic marketing, and navigating competitive pressures. The drug’s patent protection provides a significant window for revenue maximization until at least 2032, after which generic competition may intensify.

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Key Takeaways

• TOLSURA is positioned as a niche antifungal with a promising growth trajectory, supported by unmet needs in resistant fungal infections.
• Revenue estimates project a compound annual growth rate of 8–10% over the next 5 years, contingent on market conditions.
• Competitive pressures from existing generics and emerging agents will influence pricing and market share.
• Strategic expansion, especially into emerging markets and new indications, can significantly enhance its financial outlook.
• Patents and clinical positioning will be critical to maintaining market exclusivity and profitability.

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FAQs

Q1: When does TOLSURA’s patent protection expire?
A1: Patent rights are expected to last until at least 2032, depending on jurisdiction and patent extensions.

Q2: What are the main competitors to TOLSURA?
A2: Primarily fluconazole, itraconazole, posaconazole, and isavuconazole.

Q3: Is TOLSURA approved for systemic fungal infections?
A3: As of now, approved specifically for oropharyngeal candidiasis; clinical trials for broader indications are ongoing.

Q4: What are the main barriers to TOLSURA’s market growth?
A4: Pricing pressures, competition from inexpensive generics, and resistance issues.

Q5: What emerging markets present growth opportunities for TOLSURA?
A5: Countries with high HIV prevalence such as India, Nigeria, and South Africa.

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References

1. UNAIDS. (2022). Global HIV & AIDS statistics.
2. Tokunaga, R., et al. (2020). Fungal infections in HIV. Clin Infect Dis.
3. U.S. Food and Drug Administration. (2017). TOLSURA approval documents.
4. Market research reports on antifungal market (2022).
5. Patent information and economic analysis from Viamet Pharmaceuticals.

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This comprehensive analysis provides a strategic foundation for stakeholders evaluating TOLSURA’s market potential, competitive landscape, and financial outlook.