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-three patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for oteseconazole

International Patents:	63
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	50
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			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
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

International Patents for oteseconazole

Country	Patent Number	Title	Estimated Expiration
Brazil	112017018823	compostos antifúngicos e processos para a fabricação
Croatia	P20221113
Taiwan	I578987
World Intellectual Property Organization (WIPO)	2013109998
Brazil	112014017751

Market Dynamics and Financial Trajectory for Oteseconazole

Introduction to Oteseconazole

Oteseconazole, marketed as VIVJOA, is a groundbreaking azole antifungal drug developed by Mycovia Pharmaceuticals. It is specifically designed to treat recurrent vulvovaginal candidiasis (RVVC) and severe vulvovaginal candidiasis (VVC), conditions that have long been challenging to manage with existing treatments.

FDA Approval and Clinical Efficacy

The FDA approval of oteseconazole in 2022 marked a significant milestone in the treatment of RVVC. The approval was based on positive results from three phase 3 trials, including the global VIOLET studies and a US-focused study, which involved 875 patients across 11 countries. These studies demonstrated that oteseconazole significantly reduced the incidence of RVVC, with 93.3% and 96.1% of women in the global studies and 89.7% in the US study remaining recurrence-free during the maintenance period, compared to 57.2% and 60.6% for the placebo groups[2][5].

Market Need and Potential

The market need for oteseconazole is substantial, given the prevalence and recurrence rates of VVC and RVVC. Mycovia Pharmaceuticals and its partners recognize a strong demand for effective treatments, particularly for conditions that have been overlooked or underserved by existing therapies. The CEO of Mycovia, Patrick Jordan, emphasized the company's commitment to developing novel therapies for such conditions[5].

Commercial Launch and Partnerships

Mycovia Pharmaceuticals has formed strategic partnerships to expand the reach of oteseconazole. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., for development and commercialization in China, including mainland China, Hong Kong, Macau, and Taiwan. This partnership led to the commercial launch of VIVJOA in China in February 2024, making it available in the second-largest pharmaceutical market in the world[1][4].

Additionally, Mycovia partnered with Gedeon Richter Plc. to commercialize and manufacture oteseconazole in Europe, Russia, the Commonwealth of Independent States, Latin America, and Australia. These partnerships are crucial for the global distribution and accessibility of the drug[5].

Financial Trajectory

Development and Approval Costs

The development and approval costs for oteseconazole, while significant, are relatively lower compared to other therapeutic areas. Antimicrobial drugs, including oteseconazole, have average to high development and approval costs but are less costly overall when considering the cost of failures and opportunity costs of capital. The estimated average capitalized development and approval costs for antimicrobial drugs are approximately $1.508 billion, which is lower than those for oncology and non-antimicrobial comparator drugs[3].

Market Performance

The market performance of oteseconazole is expected to be strong, given its superior clinical efficacy and the significant market need. The drug's approval and subsequent commercial launch have positioned it for substantial revenue generation. While the exact financial projections are not publicly disclosed, the success in clinical trials and the strategic partnerships suggest a promising financial trajectory.

Sales Projections

The sales performance of oteseconazole is anticipated to follow the trend observed in other antimicrobial drugs. Although antimicrobial drugs generally have lower cumulative sales compared to oncology drugs, oteseconazole's unique position as the first FDA-approved treatment for RVVC could drive higher sales. The average cumulative nine-quarter sales for high-ranking antimicrobial drugs are around $42 million, but oteseconazole's market potential could exceed this average due to its innovative status and strong clinical data[3].

Competitive Landscape

Oteseconazole enters a market where existing treatments, such as fluconazole, have shown limited efficacy in preventing recurrences of VVC and RVVC. The drug's superior efficacy and convenience (a 2-day oral regimen) position it as a preferred treatment option for healthcare providers and patients. This competitive advantage is likely to drive market share and revenue growth for Mycovia Pharmaceuticals and its partners.

Regulatory Designations

Oteseconazole has received FDA Qualified Infectious Disease Product and Fast Track designations, which are indicative of its potential to address an unmet medical need. These designations can also provide financial incentives and expedite the regulatory process, further supporting the drug's commercial success[2][5].

Safety and Tolerability

The safety profile of oteseconazole has been evaluated in several studies, including those focusing on subjects with renal or hepatic impairment and the impact on QT prolongation. The most frequently reported adverse events were headache and nausea, occurring in 7.4% and 3.6% of trial participants, respectively. This safety data supports the drug's tolerability and further enhances its market appeal[2][4].

Global Expansion

The global expansion of oteseconazole is a key factor in its financial trajectory. With commercial launches in China and planned launches in other regions through partnerships with Hengrui and Gedeon Richter, the drug is poised to capture a significant share of the global antifungal market.

Conclusion

Oteseconazole, with its FDA approval, strong clinical efficacy, and strategic partnerships, is well-positioned for a successful market trajectory. The drug addresses a significant unmet medical need, offering a superior treatment option for RVVC and VVC. As it continues to expand globally, oteseconazole is expected to generate substantial revenue and solidify Mycovia Pharmaceuticals' position in the biopharmaceutical industry.

Key Takeaways

• FDA Approval: Oteseconazole is the first FDA-approved treatment for recurrent vulvovaginal candidiasis (RVVC).
• Clinical Efficacy: Demonstrated superior efficacy in reducing the incidence of RVVC compared to existing treatments.
• Market Need: Strong demand due to the prevalence and recurrence rates of VVC and RVVC.
• Partnerships: Strategic partnerships with Jiangsu Hengrui Pharmaceuticals and Gedeon Richter Plc. for global distribution.
• Financial Trajectory: Expected strong market performance driven by its innovative status and clinical data.
• Safety and Tolerability: Generally well-tolerated with manageable adverse events.

FAQs

What is oteseconazole used for?

Oteseconazole is used to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) and treat severe vulvovaginal candidiasis (VVC).

What are the key clinical trial results for oteseconazole?

Clinical trials showed that oteseconazole significantly reduced the incidence of RVVC, with 93.3% and 96.1% of women remaining recurrence-free during the maintenance period, compared to 57.2% and 60.6% for the placebo groups.

Who are the partners involved in the commercialization of oteseconazole?

Mycovia Pharmaceuticals has partnered with Jiangsu Hengrui Pharmaceuticals Co., Ltd., for commercialization in China, and with Gedeon Richter Plc. for commercialization in Europe, Russia, the Commonwealth of Independent States, Latin America, and Australia.

What are the common adverse events associated with oteseconazole?

The most frequently reported adverse events are headache and nausea, occurring in 7.4% and 3.6% of trial participants, respectively.

What regulatory designations has oteseconazole received?

Oteseconazole has received FDA Qualified Infectious Disease Product and Fast Track designations.

Sources

1. Mycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd's Commercial Launch of VIVJOA® (Oteseconazole) Capsules. Biospace.
2. FDA Approves First Drug for Recurrent Vulvovaginal Candidiasis. AJMC.
3. Antimicrobial Drugs Market Returns Analysis. ASPE.
4. Mycovia Pharmaceuticals Announces Presentation of Results from Three Safety Studies Evaluating VIVJOA (Oteseconazole). PR Newswire.
5. FDA Approves Mycovia Pharmaceuticals' VIVJOA™ (Oteseconazole). Biospace.