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Last Updated: February 12, 2025

BREXAFEMME Drug Patent Profile


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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-two patent family members in twenty-six countries.

The generic ingredient in BREXAFEMME is ibrexafungerp citrate. One supplier is listed for this compound. Additional details are available on the ibrexafungerp citrate profile page.

DrugPatentWatch® Generic Entry Outlook for Brexafemme

Brexafemme will be eligible for patent challenges on June 1, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

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Summary for BREXAFEMME
International Patents:52
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 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
Drug patent expirations by year for BREXAFEMME
Drug Prices for BREXAFEMME

See drug prices for BREXAFEMME

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BREXAFEMME
Generic Entry Date for BREXAFEMME*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for BREXAFEMME

US Patents and Regulatory Information for BREXAFEMME

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BREXAFEMME is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Scynexis BREXAFEMME ibrexafungerp citrate TABLET;ORAL 214900-001 Jun 1, 2021 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Scynexis BREXAFEMME ibrexafungerp citrate TABLET;ORAL 214900-001 Jun 1, 2021 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Scynexis BREXAFEMME ibrexafungerp citrate TABLET;ORAL 214900-001 Jun 1, 2021 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 0220544
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 25272
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 47711
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 6874
Estimated Expiration: ⤷  Try for Free

Patent: 1791645
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 47711
Estimated Expiration: ⤷  Try for Free

Patent: 39684
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 47196
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 58721
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 47711
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 47711
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 47711
Estimated Expiration: ⤷  Try for Free

San Marino

Patent: 02200202
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 234
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 47711
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 13111
Estimated Expiration: ⤷  Try for Free

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
World Intellectual Property Organization (WIPO) 2016118396 ⤷  Try for Free
South Korea 20200044823 산성 pH에서 증진된 활성을 갖는 항진균제 ⤷  Try for Free
Portugal 3247711 ⤷  Try for Free
Spain 2932658 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for BREXAFEMME

Introduction

BREXAFEMME, developed by SCYNEXIS, Inc., is a groundbreaking antifungal medication that has marked a significant milestone in the treatment of vaginal yeast infections. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

FDA Approval and Market Entry

BREXAFEMME, or ibrexafungerp, was approved by the FDA in June 2021 as the first and only oral non-azole treatment for vaginal yeast infections. This approval was a culmination of years of research and development, positioning SCYNEXIS as a commercial-stage antifungal company[3].

Commercial Performance

Since its approval, BREXAFEMME has shown steady growth in its commercial performance. In the first quarter of 2023, net product revenues from BREXAFEMME increased to $1.1 million, up from $0.7 million in the same period of 2022. Similarly, in the fourth quarter of 2022, net product revenues rose to $1.4 million, compared to $0.6 million in the fourth quarter of 2021[1][5].

Market Expansion and Access

The drug has seen continued growth in prescriptions and expansion of access. Recent updates include new coverage with a major national pharmacy benefit manager (PBM), adding an additional 21 million commercially insured lives. This expanded coverage has been crucial in maximizing the commercial value of BREXAFEMME for the treatment of vulvovaginal candidiasis (VVC) and the anticipated indication of prevention of recurrent VVC (RVVC)[4].

Strategic Partnerships

In a significant move to enhance the commercial potential of BREXAFEMME, SCYNEXIS entered into an exclusive agreement with GlaxoSmithKline (GSK) on March 30, 2023. Under this agreement, GSK will commercialize and further develop BREXAFEMME for all indications. SCYNEXIS is set to receive an upfront payment of $90 million and is eligible for potential milestone-based payments totaling $503 million, along with royalties based on cumulative annual sales in the mid-single digit to mid-teen range[1].

Financial Impact of Partnerships

The partnership with GSK has substantial financial implications for SCYNEXIS. The upfront payment and potential milestone payments significantly bolster the company's financial position, enabling it to focus on other clinical developments and strategic initiatives. For instance, SCYNEXIS ended Q3 2024 with cash, cash equivalents, and investments of $84.9 million, including a recently earned $10.0 million development milestone[2].

Cost Structure and Operational Efficiency

SCYNEXIS has been working to optimize its cost structure. In Q1 2023, the selling, general, and administrative (SG&A) expenses decreased to $4.8 million from $14.6 million in Q1 2022, primarily due to reduced commercial expenses and workforce reductions in the Commercial and Medical Affairs functions. This trend continued in Q3 2024, with SG&A expenses decreasing to $2.9 million from $5.0 million in the same period of 2023[1][2].

Research and Development

The company continues to invest in research and development, particularly in the clinical development of ibrexafungerp for severe, hospital-based indications. Multiple ongoing Phase 3 studies are progressing, with a potential first approval in hospital indications anticipated in 2024. This strategic refocusing is expected to provide higher long-term returns by leveraging the broad potential of ibrexafungerp in treating serious and often resistant fungal infections[4].

Financial Performance and Losses

Despite the growth in revenues, SCYNEXIS has reported net losses. In Q1 2023, the net loss was $33.9 million, compared to a net loss of $5.5 million in Q1 2022. The increase in net loss was largely due to the fair value adjustment related to warrant liabilities. However, in Q3 2024, the net loss improved to $2.8 million, reflecting better operational efficiency and the impact of strategic cost reductions[1][2].

Future Outlook

The future outlook for BREXAFEMME is promising, driven by its unique therapeutic profile, expanded market access, and the strategic partnership with GSK. As SCYNEXIS continues to advance its clinical programs and leverage the commercial potential of ibrexafungerp, the company is well-positioned to maximize the value of this innovative antifungal treatment.

Key Takeaways

  • FDA Approval: BREXAFEMME was approved by the FDA in June 2021 as the first oral non-azole treatment for vaginal yeast infections.
  • Commercial Growth: Net product revenues have shown steady growth, with $1.1 million in Q1 2023 and $1.4 million in Q4 2022.
  • Strategic Partnerships: The exclusive agreement with GSK includes an upfront payment of $90 million and potential milestone payments totaling $503 million.
  • Cost Optimization: Significant reductions in SG&A expenses have improved operational efficiency.
  • R&D Focus: SCYNEXIS is refocusing on clinical development for severe, hospital-based indications with potential approvals anticipated in 2024.

FAQs

Q: What is BREXAFEMME, and how is it unique?

BREXAFEMME, or ibrexafungerp, is the first and only oral non-azole treatment approved by the FDA for vaginal yeast infections, marking a significant milestone in antifungal therapy.

Q: How has the commercial performance of BREXAFEMME been since its approval?

Since its approval, BREXAFEMME has shown steady growth in net product revenues, increasing from $0.7 million in Q1 2022 to $1.1 million in Q1 2023.

Q: What is the nature of the partnership between SCYNEXIS and GSK for BREXAFEMME?

SCYNEXIS and GSK have an exclusive agreement where GSK will commercialize and further develop BREXAFEMME for all indications, with SCYNEXIS receiving an upfront payment of $90 million and potential milestone payments totaling $503 million.

Q: How has SCYNEXIS optimized its cost structure?

SCYNEXIS has significantly reduced its SG&A expenses through decreased commercial expenses and workforce reductions, improving operational efficiency.

Q: What are the future prospects for BREXAFEMME in the market?

With its unique therapeutic profile, expanded market access, and strategic partnership with GSK, BREXAFEMME is poised for continued growth and potential approvals in hospital-based indications in 2024.

Sources

  1. SCYNEXIS Announces First Quarter 2023 Financial Results and Provides Corporate Update. BioSpace.
  2. SCYNEXIS Reports Third Quarter 2024 Financial Results and Provides Corporate Update. SCYNEXIS Investor Relations.
  3. SCYNEXIS Announces FDA Approval of BREXAFEMME (ibrexafungerp tablets) as the First and Only Oral Non-azole Treatment for Vaginal Yeast Infections. BioSpace.
  4. SCYNEXIS Provides Corporate, Commercial and R&D Strategy Updates to Expand Market Potential for Its First-in-Class Antifungal. SCYNEXIS.
  5. SCYNEXIS Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update. GlobeNewswire.

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