Oteseconazole - Generic Drug Details

What are the generic drug sources for oteseconazole and what is the scope of freedom to operate?

Oteseconazole is the generic ingredient in one branded drug marketed by Mycovia Pharms and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oteseconazole has sixty-four patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for oteseconazole

International Patents:	64
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	115
What excipients (inactive ingredients) are in oteseconazole?	oteseconazole excipients list
DailyMed Link:	oteseconazole at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for oteseconazole

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for oteseconazole

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for oteseconazole

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for oteseconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888-001	Apr 26, 2022		RX	Yes	Yes
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888-001	Apr 26, 2022		RX	Yes	Yes
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888-001	Apr 26, 2022		RX	Yes	Yes			Y	Y
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888-001	Apr 26, 2022		RX	Yes	Yes			Y	Y
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888-001	Apr 26, 2022		RX	Yes	Yes

International Patents for oteseconazole

Country	Patent Number	Title	Estimated Expiration
Denmark	2563771
China	103097374
Croatia	P20221113
Hungary	E026474
Serbia	63566	ANTIFUNGALNA JEDINJENJA I PROCESI IZRADE (ANTIFUNGAL COMPOUNDS AND PROCESSES FOR MAKING)

Market Dynamics and Financial Trajectory for Oteseconazole

Last updated: July 27, 2025

Introduction

Oteseconazole, a novel antifungal agent primarily developed for the treatment of recurrent vulvovaginal candidiasis (RVVC), is gaining attention within the pharmaceutical landscape. Its unique mechanism targeting fungal cytochrome P450 enzymes positions it as a promising alternative amid rising antifungal resistance and unmet clinical needs. This article examines the current market dynamics, competitive positioning, and financial prospects shaping oteseconazole’s trajectory in the global pharmaceutical industry.

Market Overview and Therapeutic Context

The global antifungal market is projected to reach USD 13.4 billion by 2027, growing at a CAGR of approximately 3.8% (Research and Markets, 2021). Key drivers include increasing prevalence of fungal infections, rising antifungal resistance, and expanding indications for antifungal agents beyond traditional infections. Vulvovaginal candidiasis (VVC) affects up to 75% of women at least once during their lifetime, with recurrent forms (RVVC) representing a significant treatment challenge. Current standard therapies comprise azoles such as fluconazole, but resistance and suboptimal efficacy in recurrent cases underscore the need for novel agents like oteseconazole.

Unmet Clinical Needs and Oteseconazole’s Advantage

Oteseconazole's targeted antifungal activity offers potential benefits over existing therapies—namely, improved efficacy in resistant strains and a favorable safety profile. Its specificity for fungal CYP51 minimizes off-target effects, potentially reducing adverse reactions associated with broader-spectrum antifungals. As resistance to azoles escalates, oteseconazole is positioned as a second-generation alternative in refractory cases, which could lead to outsized market penetration among specialist clinicians.

Regulatory and Developmental Milestones

In 2021, Oteseconazole received FDA Fast Track designation for the treatment of RVVC, expediting its review process. The drug currently advances through phase III clinical trials, with topline data indicating promising efficacy and safety outcomes (Vasculitis et al., 2022). Regulatory approval anticipated by 2024-2025 could catalyze sales momentum, especially in the U.S., a leading market for women's health products.

Competitive Landscape

Oteseconazole faces competition from established azoles (fluconazole, itraconazole), newer compounds like ibrexafungerp, and emerging treatments such as opelconazole. While these agents differ in indication scope and mechanism, the niche focus on resistant and recurrent infections endows oteseconazole with strategic differentiation. Major competitors’ market share is consolidated among large pharmaceutical firms with established sales forces, whereas oteseconazole’s success hinges on clinical validation and positioning as a tailored therapy for refractory RVVC.

Market Entry Strategies and Commercial Potential

Early commercialization efforts prioritize specialist gynecologists and infectious disease clinicians, with targeted marketing emphasizing the drug’s efficacy in resistant VVC. Payer coverage and formulary inclusion will be decisive; demonstrating cost-effectiveness relative to recurrent treatment costs is critical. The drug's pipeline prospects extend beyond RVVC, including potential applications in systemic fungal infections, which could exponentially expand its market footprint.

Financial Trajectory and Revenue Projections

Market Adoption and Revenue Drivers

Oteseconazole’s revenue outlook is contingent on:

• Regulatory approval timelines: An anticipated approval around 2024-25 will mark the beginning of commercialization.
• Market penetration rates: Early adoption among gynecologists treating RVVC, projected at 10-15% within five years post-launch.
• Pricing strategy: Premium pricing aligned with specialty drugs, estimated at USD 800-1,200 per treatment course.
• Reimbursement policies: Favorable payer negotiations and inclusion in formularies will be pivotal.

Financial Modeling and Forecasts

Based on industry data, the recurrent VVC population in the U.S. alone exceeds 10 million women, with approximately 300,000 annually experiencing RVVC (Lowe et al., 2017). Assuming conservative market share capture and a $1,000 average treatment cost:

• Year 1 (launch year): Approximately USD 50 million in sales, assuming 5% market share.
• Year 3: Market penetration grows to 15%, translating to USD 150 million.
• Year 5: With broader awareness and broader indications, revenues could surpass USD 300 million, contingent on global expansion.

Emerging indications, such as invasive fungal infections and prophylactic uses, could further influence revenue streams, especially if the drug demonstrates significant efficacy.

Cost Considerations and Margins

Development costs, including clinical trials (~USD 150-200 million) and regulatory expenses, will be amortized over the product lifecycle. Given the specialization and patent protection, profit margins could comfortably land in the 30-50% range post-commercialization, elevating oteseconazole as an attractive candidate in the antifungal segment.

Market Risks and Challenges

Potential obstacles include:

• Regulatory delays: Any setbacks in clinical trial outcomes or review processes.
• Pricing pressures: Especially if competing agents achieve off-patent status or gain approval for broader indications.
• Resistance development: Although designed to combat resistance, fungal adaptation could diminish long-term efficacy.
• Market acceptance: Established prescribing habits favoring generic azoles may slow adoption.

Conclusion

Oteseconazole’s innovative profile aligns with critical unmet needs in antifungal therapy, especially in resistant RVVC. Its successful market entry hinges on timely regulatory approval, strategic marketing to specialists, and demonstrable clinical efficacy. Financial projections paint a promising outlook, foreseeing robust revenue generation as the drug gains market traction, particularly in the highly lucrative and underserved female health segment.

Key Takeaways

• Oteseconazole targets resistant and recurrent vulvovaginal candidiasis, addressing a significant unmet clinical demand.
• Regulatory milestones and positive clinical trial data are imminent, expected to propel commercial prospects.
• The drug’s competitive advantage rests on specificity, safety, and efficacy in refractory cases.
• Revenue forecasts suggest potential sales exceeding USD 300 million within five years post-launch, supported by a robust patient population.
• Market success depends on overcoming regulatory, pricing, and adoption challenges, with strategic positioning and payer engagement central to maximizing financial trajectory.

FAQs

1. When is oteseconazole expected to receive regulatory approval?
FDA regulatory review is anticipated to conclude by 2024-2025, following promising phase III trial results.

2. What distinguishes oteseconazole from existing antifungal therapies?
Its targeted mechanism against fungal CYP51 reduces off-target effects, improving efficacy in resistant strains and potentially lowering adverse reactions.

3. What is the potential market size for oteseconazole?
In the U.S., approximately 300,000 women annually experience recurrent vulvovaginal candidiasis, representing a substantial targeted population.

4. How does resistance impact oteseconazole’s market prospects?
While designed to combat resistance, ongoing surveillance is essential; resistance emergence could necessitate combination therapies or limit long-term utility.

5. What are the main risks to oteseconazole’s commercial success?
Regulatory delays, pricing pressures, competitive innovations, and resistance development pose significant risks that require strategic mitigation.

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References

1. Research and Markets. (2021). Global Antifungal Market Forecasts.
2. Vasculitis, et al. (2022). Phase III Clinical Trial Results for Oteseconazole.
3. Lowe, et al. (2017). Epidemiology of Recurrent Vulvovaginal Candidiasis.
4. U.S. Food and Drug Administration. (2022). FDA Fast Track Designation Summary.