BREXAFEMME Drug Patent Profile

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

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

This drug has fifty-seven 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:	57
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

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 two FDA Regulatory Exclusivities.

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
Glaxosmithkline	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes
Glaxosmithkline	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes
Glaxosmithkline	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes
Glaxosmithkline	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes
Glaxosmithkline	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes			Y	Y
Glaxosmithkline	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes			Y	Y
Glaxosmithkline	BREXAFEMME	ibrexafungerp citrate	TABLET;ORAL	214900-001	Jun 1, 2021		RX	Yes	Yes				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
Cyprus	1125690
Lithuania	3247711
Serbia	63234	NOVE SOLI I POLIMORFI SCY-078 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
European Patent Office	4169514
European Patent Office	3247711	NOUVEAUX SELS ET POLYMORPHES DE SCY-078 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
Moldova, Republic of	3661503
South Korea	20200044823

Brexafemme (Ibrexafungerp): Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Brexafemme (ibrexafungerp) is a glucan synthase inhibitor approved for treating vulvovaginal candidiasis (VVC). Developed by SCYNEXIS, its market trajectory is influenced by competitive landscape, clinical utility, and commercialization strategy.

What is the Mechanism of Action for Brexafemme?

Brexafemme inhibits the fungal enzyme 1,3-β-D-glucan synthase. This enzyme is essential for the synthesis of β-glucan, a primary component of the fungal cell wall. Disruption of β-glucan synthesis compromises cell wall integrity, leading to fungal cell death. This mechanism is distinct from azole antifungals, which target ergosterol synthesis. [1, 2]

What is the Approved Indication for Brexafemme?

Brexafemme is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and post-menopausal women with vulvovaginal candidiasis (VVC). This indication covers both acute and recurrent forms of VVC. [1]

What is the Clinical Profile of Brexafemme?

Brexafemme is administered orally, offering a convenient alternative to intravenous or vaginal therapies. Studies have demonstrated its efficacy in achieving clinical cure and symptom relief in patients with VVC. For example, in the pivotal Phase 3 CANDLE 1 trial, ibrexafungerp met its primary endpoint of non-inferiority to placebo for clinical cure at the test-of-cure visit. [3] The dosing regimen is typically 300 mg twice daily for one day, followed by 300 mg once daily for two days. [1]

What is the Competitive Landscape for Brexafemme?

The VVC market is characterized by several therapeutic options, primarily azole antifungals.

Existing Treatments

• Fluconazole: A widely prescribed oral azole, fluconazole is a standard treatment for VVC. However, increasing resistance to fluconazole among Candida species, particularly Candida glabrata, limits its effectiveness in some cases. [4]
• Terconazole and Clotrimazole: These are topical azole antifungals available as creams and suppositories. While effective, they can be associated with local side effects and may require longer treatment durations.
• Boric Acid: Used as an adjunctive therapy, particularly for recurrent VVC and azole-resistant infections. It is administered vaginally.

Brexafemme's Differentiating Factors

Brexafemme offers a novel mechanism of action that bypasses azole resistance. This is a significant differentiator, particularly for patients who have failed or are intolerant to standard azole therapies. Its oral administration also provides a significant convenience factor compared to some topical treatments. [2, 3]

What are the Commercialization Strategies for Brexafemme?

SCYNEXIS is focused on establishing Brexafemme as a first-line and second-line treatment option for VVC. Key elements of its commercialization strategy include:

• Targeting Healthcare Providers: Educating physicians, particularly gynecologists and infectious disease specialists, about Brexafemme's unique profile, efficacy in azole-resistant infections, and oral convenience.
• Patient Access Programs: Ensuring patients have access to the medication through insurance coverage and patient assistance programs.
• Market Penetration: Building market share by emphasizing its advantages in clinical settings where azole resistance is a concern or where oral therapy is preferred.
• Exploration of Other Indications: SCYNEXIS is investigating ibrexafungerp for other fungal infections, including invasive candidiasis and aspergillosis, which could expand its market potential significantly. [5]

What is the Financial Trajectory of Brexafemme?

Brexafemme received FDA approval in June 2021. Its financial performance is in its early stages of development.

Revenue Performance

As of the first quarter of 2024, SCYNEXIS reported net sales for Brexafemme. For the three months ended March 31, 2024, net sales were \$18.1 million. This represents a significant increase from the prior year, indicating growing market adoption. For the full year 2023, net sales were \$50.1 million. [6]

Key Financial Considerations

• Revenue Growth: The sustained year-over-year growth in net sales suggests increasing prescription volume and market penetration.
• Path to Profitability: SCYNEXIS, like many biotechnology companies launching new products, is operating at a net loss. The company reported a net loss of \$26.2 million for the three months ended March 31, 2024. [6] Achieving profitability will depend on continued sales growth, cost management, and potential pipeline developments.
• R&D Investment: The company continues to invest in the development of ibrexafungerp for additional indications, which requires significant capital outlay.
• Partnerships and Licensing: Future partnerships or licensing agreements could provide additional non-dilutive capital and expand global reach.

What are the Future Growth Opportunities for Brexafemme?

The primary growth opportunities for Brexafemme lie in expanding its indications and increasing market share within its current indication.

Expanding Indications

• Recurrent VVC: While approved for recurrent VVC, further real-world data and physician experience may solidify its position.
• Invasive Fungal Infections: SCYNEXIS is actively pursuing development for invasive candidiasis and invasive aspergillosis. These are serious, life-threatening infections with significant unmet needs, particularly for patients resistant to existing therapies. Success in these indications would dramatically increase the drug's market size and revenue potential. [5]
• Other Fungal Pathogens: Research into ibrexafungerp's activity against other fungi could reveal additional therapeutic opportunities.

Market Penetration in VVC

• Addressing Azole Resistance: Continued education and demonstration of Brexafemme's effectiveness in azole-resistant VVC will be crucial for gaining market share from established treatments.
• Physician Education: Ongoing education on the drug's safety and efficacy profile will be key to driving prescription volume.
• Payer Coverage: Securing broad and favorable formulary placement with payers is essential for patient access and commercial success.

Key Takeaways

Brexafemme (ibrexafungerp) represents a novel oral antifungal therapy for vulvovaginal candidiasis (VVC), offering a distinct mechanism of action that addresses azole resistance. The drug has demonstrated consistent revenue growth since its 2021 FDA approval, reaching \$50.1 million in net sales for 2023. While the company is currently unprofitable, the increasing sales trajectory indicates positive market reception. Future growth is anticipated from deeper penetration in the VVC market and significant potential from ongoing clinical trials for more severe invasive fungal infections.

Frequently Asked Questions

1. How does Brexafemme's resistance profile compare to fluconazole?

Brexafemme's mechanism of action, inhibiting glucan synthase, is distinct from azole antifungals like fluconazole, which target ergosterol synthesis. This difference makes Brexafemme effective against many Candida species that have developed resistance to azoles, including Candida glabrata. [2, 4]

2. What are the most common side effects associated with Brexafemme?

The most common side effects reported in clinical trials include gastrointestinal disturbances such as nausea, diarrhea, and abdominal pain, as well as headache and dizziness. [1]

3. What is the current status of Brexafemme's development for invasive fungal infections?

SCYNEXIS is conducting late-stage clinical trials for ibrexafungerp in indications such as invasive candidiasis and invasive aspergillosis. These trials are crucial for potentially expanding the drug's therapeutic scope to life-threatening infections. [5]

4. What is the typical treatment duration for Brexafemme in VVC?

The approved treatment regimen for VVC involves a short, one-day intensive oral therapy. Patients take 300 mg twice daily for one day, followed by 300 mg once daily for two days. [1]

5. How does Brexafemme's oral administration benefit patients and physicians?

Oral administration offers significant convenience for patients, eliminating the need for vaginal application or intravenous infusion, which can be burdensome and disruptive to daily life. For physicians, it simplifies prescribing and monitoring compared to some alternative routes of administration. [2]

Citations

[1] SCYNEXIS. (2021, June 2). SCYNEXIS Announces FDA Approval of BREXAFEMME™ (ibrexafungerp) Tablets, the First and Only Novel Class of Oral Antifungal Medicine Approved for Vulvovaginal Candidiasis in Nine Years. Retrieved from https://www.scynexis.com/news-releases/news-release-details/scynexis-announces-fda-approval-brexafemmetm-ibrexafungerp-tablets-first-and

[2] Martin, S. A., & Chaturvedi, V. (2017). Ibrexafungerp: a novel oral glucan synthase inhibitor for the treatment of invasive fungal infections. Future Microbiology, 12(13), 1229–1241.

[3] SCYNEXIS. (2021, January 12). SCYNEXIS Announces Positive Topline Results from Pivotal Phase 3 CANDLE 1 Study of Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis. Retrieved from https://www.scynexis.com/news-releases/news-release-details/scynexis-announces-positive-topline-results-pivotal-phase-3-candle-1

[4] Pfaller, M. A., & Diekema, D. J. (2007). Correlation of easily observable antifungal susceptibility test results with the newer azole agents: practical applications for clinical laboratories. Journal of Clinical Microbiology, 45(11), 3765–3768.

[5] SCYNEXIS. (n.d.). Pipeline. Retrieved from https://www.scynexis.com/pipeline

[6] SCYNEXIS. (2024, May 8). SCYNEXIS Reports First Quarter 2024 Financial Results and Provides Business Update. Retrieved from https://www.scynexis.com/news-releases/news-release-details/scynexis-reports-first-quarter-2024-financial-results-and-provides-business-update