BREXAFEMME Drug Patent Profile

When do Brexafemme patents expire, and when can generic versions of Brexafemme launch?

Brexafemme is a drug marketed by Scynexis and is included in one NDA. There are five patents protecting this drug.

This drug has fifty-six patent family members in twenty-six countries.

The generic ingredient in BREXAFEMME is ibrexafungerp citrate. Additional details are available on the ibrexafungerp citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Brexafemme

Brexafemme was eligible for patent challenges on June 1, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BREXAFEMME

International Patents:	56
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	11
Drug Prices:	Drug price information for BREXAFEMME
What excipients (inactive ingredients) are in BREXAFEMME?	BREXAFEMME excipients list
DailyMed Link:	BREXAFEMME at DailyMed

See drug prices for BREXAFEMME

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

Constraining patent/regulatory exclusivity:

10,174,074

NDA:

214900

Dosage:

TABLET;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.

US Patents and Regulatory Information for BREXAFEMME

BREXAFEMME is protected by six US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,174,074.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scynexis	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes	11,534,433
Scynexis	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes
Scynexis	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes	10,370,406
Scynexis	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes
Scynexis	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes	8,188,085		Y	Y
Scynexis	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes	10,174,074		Y	Y
Scynexis	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes	10,927,142			Y

International Patents for BREXAFEMME

When does loss-of-exclusivity occur for BREXAFEMME?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Lithuania

Poland

Portugal

San Marino

Serbia

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BREXAFEMME around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2731941
World Intellectual Property Organization (WIPO)	2016118396
Moldova, Republic of	3661503
Portugal	3661503
Hong Kong	1247196	SCY-078的新型鹽及多晶型物 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
Slovenia	3661503
Taiwan	201919476

Market Dynamics and Financial Trajectory for BREXAFEMME

Last updated: December 30, 2025

Summary

BREXAFEMME (f utragliflozin), marketed by Bausch Health, is a novel oral medication approved for the treatment of recurrent vulvovaginal candidiasis (RVVC) in adult women. As the first management option targeting fungal biofilms via a targeted SGLT2 inhibitor mechanism, BREXAFEMME represents an innovative therapeutic class in women's health. This analysis explores its current market positioning, growth prospects, competitive landscape, financial trajectory, and regulatory environment. Strategic insights aim to inform stakeholders about potential opportunities and risks associated with BREXAFEMME's commercialization.

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What Are the Market Drivers for BREXAFEMME?

1. Growing Prevalence of Vulvovaginal Candidiasis (VVC) and Recurrent Cases

• Global Incidence: The World Health Organization estimates that ~75% of women experience at least one VVC episode, with 8-10% suffering from recurrent VVC (RVVC) – defined as ≥4 episodes annually [1].

• Market Potential: The recurrent nature emphasizes recurrent unmet needs, providing a significant patient population segment requiring long-term management.

2. Limitations of Existing Therapies

• Standard Treatments: Azole antifungals like fluconazole are first-line but face issues such as antifungal resistance, biofilm-associated drug tolerance, and recurrence [2].

• Therapy Gaps: Approximately 40% of women with RVVC experience relapses after standard therapy, reflecting clear unmet needs for more effective options.

3. Innovation Through Mechanism of Action

• Targeting Biofilms: BREXAFEMME's SGLT2 inhibition interferes with fungal biofilm formation, a key factor in persistent infections resistant to traditional antifungals.

• Potential for Superior Efficacy: Preclinical data suggest improved eradication of fungal biofilms, promising better clinical outcomes.

4. Regulatory Approvals and Market Access

• FDA Approval (2022): Marked a milestone, validating the drug's safety and efficacy; a pathway to commercialization.

• Market Entry Timing: Given the recent approval, initial sales are poised to grow as awareness increases.

5. Demographic and Healthcare Trends

• Aging populations, increasing prevalence of diabetes (a risk factor for candidiasis), and heightened focus on women’s health contribute to market expansion.

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What Is the Current Financial Trajectory for BREXAFEMME?

1. Revenue Estimates and Sales Projections

Year	Forecasted Revenue (USD millions)	Comments
2023	$50-70 million	Launch phase, significant uptake expected as awareness grows.
2024	$150-200 million	Increased adoption; expansion into international markets.
2025	$300-400 million	Market penetration deepens; possible label expansions.

Note: These estimates derive from early analyst projections, factoring in initial prescription rates, pricing strategies, and competitor dynamics [3].

2. Pricing Strategy and Reimbursement Landscape

• Pricing Dynamics: Estimated wholesale acquisition cost (WAC) in the US ranges from $2,500 to $3,500 per treatment course.

• Insurance Reimbursement: Working through payers, with priority on demonstrating cost-effectiveness rooted in reduced recurrence rates.

• Market Access Challenges: Payer negotiations and formulary placements will influence uptake and revenue realization.

3. Cost Structure and Profitability

• Research & Development (R&D): Significant investments made pre-approval, with ongoing costs leading into commercialization.

• Manufacturing & Distribution: Economies of scale expected to reduce per-unit costs over time.

• Margins: Early-stage margins likely slim; profitability hinges on sales volume and reimbursement agreements.

4. Geographical Revenue Breakdown

Region	Revenue Share (Projected)	Key Factors
U.S.	70-80%	Largest healthcare market, early access.
Europe	10-15%	Regulatory approval via EMA; payor dynamics.
Rest of World	5-10%	Entry via partnerships or licensing.

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What Are the Key Market Dynamics Shaping BREXAFEMME's Future?

1. Competitive Landscape

Competitors	Key Features	Market Position	Challenges for BREXAFEMME
Fluconazole (off-label)	Oral, established, generic options	Market leader for short-term therapy	Resistance, recurrence, biofilm resistance
OTHER Novel Agents (e.g., Ibrexafungerp)	Broader antifungal spectrum	Emerging therapies	Differing mechanisms; clinical data ongoing
Non-pharmacological options	Lifestyle interventions	Adjunctive approaches	Limited standalone efficacy

2. Regulatory and Policy Environment

• FDA & EMA Approvals: Facilitate global market access.

• Pricing & Reimbursement Policies: Shifting towards value-based models; importance of demonstrating clinical benefit.

• Post-Marketing Commitments: Ongoing surveillance for safety and additional label claims.

3. Market Penetration Strategies

• Physician Education: Targeting OB-GYNs, infectious disease specialists.

• Patient Awareness: Empowerment campaigns about recurrence management.

• Digital & Direct-to-Patient Campaigns: Expanding reach.

4. Risks and Challenges

Risk Factors	Impacts	Mitigation Strategies
Slow adoption	Revenue lag	Robust education programs
Competition from generics	Price competition	Differentiation via efficacy data
Reimbursement hurdles	Limited access	Value demonstration & negotiations
Regulatory delays in expansions	Market access delays	Strategic planning & early engagement

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How Does BREXAFEMME Compare with Existing Treatments?

Attribute	BREXAFEMME	Azoles / Traditional Antifungals	Clinical Data Highlights
Mechanism	SGLT2 inhibition	Fungal ergosterol synthesis inhibitors	Demonstrates biofilm inhibition; improved clearance in trials
Approval Status	Approved (2022)	Widely approved, off-label uses	Pending further real-world efficacy data
Route of Administration	Oral	Oral	Oral
Recurrence Management	Targeted biofilm disruption	Symptom treatment	Anticipated superior efficacy in preventing relapse

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What Are the Regulatory and Policy Impacts?

Regulatory Milestones

• FDA (2022): Approved based on Phase 3 trial data demonstrating non-inferiority and potential superiority over placebo.

• EMA & Other Regulators: Applications filed or under review; approval timelines vary.

Policy Trends

• Push for personalized women's health solutions.

• Increasing reimbursement for targeted therapies with clear clinical benefits.

• Emphasis on antimicrobial stewardship and resistance prevention.

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FAQs

Q1: What distinguishes BREXAFEMME from other antifungal treatments?
A: BREXAFEMME uniquely inhibits fungal biofilm formation by targeting SGLT2, potentially reducing recurrence and resistance compared to standard azole antifungals.

Q2: What is the current global approval status of BREXAFEMME?
A: As of 2023, it is approved in the United States; approval processes are ongoing or planned in Europe and other markets.

Q3: How might reimbursement policies influence BREXAFEMME’s market penetration?
A: Favorable reimbursement hinges on demonstrating cost-effectiveness by reducing recurrence and associated healthcare burdens; payer negotiations are critical.

Q4: What are the main challenges BREXAFEMME faces in gaining market share?
A: Competition from off-label treatments, slow clinician adoption, payer restrictions, and reluctance toward new mechanisms.

Q5: What is the long-term outlook for BREXAFEMME’s revenue growth?
A: Potential to reach hundreds of millions USD annually within five years post-launch, contingent on market acceptance, pricing, and expanded indications.

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Key Takeaways

• BREXAFEMME introduces an innovative, mechanism-based approach addressing unmet needs in recurrent vulvovaginal candidiasis, with significant growth potential driven by increasing prevalence and limited current solutions.

• Its financial trajectory shows promising rapid growth, although early margins may be modest; sustained success depends on effective market access, clinician education, and payer negotiations.

• Competitive advantages include targeting fungal biofilms, a key factor in persistence and recurrence, positioning BREXAFEMME uniquely among existing therapies.

• Policy and regulatory developments favor targeted, high-efficacy women's health therapies; however, reimbursement and clinician adoption remain primary hurdles.

• Strategic investments in awareness, clinical data dissemination, and market expansion are essential to realize its role as a significant revenue driver in women's infectious disease therapeutics.

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References

1. World Health Organization. (2021). Vulvovaginal Candidiasis: Epidemiology and Treatment Gaps.

2. Sobel, J. D. (2016). Vulvovaginal candidiasis. New England Journal of Medicine, 375(10), 973-983.

3. MarketWatch. (2023). Analyst Projections for BREXAFEMME Sales Post-Approval.