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Last Updated: February 12, 2025

Ibrexafungerp citrate - Generic Drug Details


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What are the generic sources for ibrexafungerp citrate and what is the scope of freedom to operate?

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

Ibrexafungerp citrate has fifty-two patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for ibrexafungerp citrate
International Patents:52
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:ibrexafungerp citrate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ibrexafungerp citrate
Generic Entry Date for ibrexafungerp citrate*:
Constraining patent/regulatory exclusivity:
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 ibrexafungerp citrate

US Patents and Regulatory Information for ibrexafungerp citrate

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 Y Y ⤷  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

Market Dynamics and Financial Trajectory for Ibrexafungerp Citrate

Introduction to Ibrexafungerp Citrate

Ibrexafungerp, marketed as BREXAFEMME, is a novel oral glucan synthase inhibitor developed by SCYNEXIS, Inc. for the treatment of various fungal infections. This drug has been making significant strides in the pharmaceutical market, particularly in the antifungal segment.

Clinical Significance and Approval

Ibrexafungerp was FDA-approved on June 1, 2021, for the treatment of vulvovaginal candidiasis (VVC) in adult and postmenarchal pediatric females[4]. It has demonstrated efficacy in reducing the incidence of recurrent VVC through a well-designed phase 3 trial. The drug's unique mechanism of action and high bioavailability make it a promising treatment option for invasive candidiasis and other fungal infections.

Market Need and Target Population

Recurrent vulvovaginal candidiasis (RVVC) affects millions of women worldwide, with a global annual prevalence of 3871 per 100,000 women. This condition significantly impacts the quality of life, causing moderate to severe symptoms and psychological distress. Ibrexafungerp addresses this unmet need by providing an effective and convenient treatment option[4].

Commercial Performance and Sales

Since its launch in August 2021, BREXAFEMME has shown promising commercial performance. In 2021, it generated $1.1 million in net sales, with approximately 4,600 total prescriptions written. The drug was prescribed by over 1,600 healthcare providers, and commercial insurance coverage expanded to include plans representing more than 81 million commercially-insured lives[5].

Financial Trajectory of SCYNEXIS, Inc.

Revenue and Licensing Agreements

SCYNEXIS has received significant financial support through licensing agreements. The company received an upfront payment of $90 million and a development milestone of $25 million from GSK as part of an exclusive license agreement for the development, manufacturing, and commercialization of ibrexafungerp. This agreement has a total potential value of $448 million plus royalties[3].

Research and Development Expenses

The company's research and development expenses have been substantial, reflecting the ongoing clinical trials and development activities. For the full year 2023, R&D expenses increased to $30.9 million from $27.3 million in the previous year, driven by increased clinical costs and other development activities[3].

Cash Runway and Financial Stability

As of September 30, 2024, SCYNEXIS had a cash balance of $84.9 million, providing a projected cash runway into Q3 2026. This financial stability is crucial for continuing the development and commercialization of ibrexafungerp[2].

Clinical Trials and Pipeline

Ibrexafungerp is currently undergoing phase II and phase III clinical trials for various indications, including invasive candidiasis and aspergillosis. The MARIO study, a global Phase 3 trial evaluating ibrexafungerp as an oral step-down treatment for invasive candidiasis, is a key component of the drug's development pipeline[5].

Drug Interaction and Tolerability

Ibrexafungerp has shown a favorable drug interaction and tolerability profile. This is significant for its potential use in a broad patient population, including those with complex medical histories and multiple drug regimens[1].

Regulatory Milestones and Payments

SCYNEXIS is eligible to receive various milestone payments from GSK, including development, regulatory approval, commercial, and sales milestones. The delivery of final study reports from completed trials is expected to trigger a $10 million development milestone payment in the first half of 2024[3].

Global Expansion and Partnerships

The company has also entered into an exclusive license and collaboration agreement with Hansoh Pharma for the research, development, and commercialization of ibrexafungerp in the Greater China region, further expanding its global reach[5].

Challenges and Future Outlook

Despite the positive trajectory, there are challenges to consider, such as the potential cross-contamination of ibrexafungerp drug substance with a non-antibacterial beta-lactam compound, which has delayed commercialization and further clinical development. However, with ongoing positive clinical data and strong financial support, the outlook for ibrexafungerp remains promising[3].

Key Takeaways

  • FDA Approval: Ibrexafungerp was FDA-approved in June 2021 for the treatment of VVC.
  • Commercial Performance: Generated $1.1 million in net sales in 2021 with expanding commercial insurance coverage.
  • Licensing Agreements: Significant financial support from GSK with a total potential value of $448 million plus royalties.
  • Clinical Trials: Ongoing phase II and phase III trials for invasive candidiasis and other fungal infections.
  • Financial Stability: Projected cash runway into Q3 2026 with a current cash balance of $84.9 million.
  • Global Expansion: Partnerships for regional commercialization, including the Greater China region.

FAQs

Q: What is the primary indication for which ibrexafungerp was FDA-approved?

A: Ibrexafungerp was FDA-approved for the treatment of vulvovaginal candidiasis (VVC) in adult and postmenarchal pediatric females.

Q: What are the key financial milestones for SCYNEXIS related to ibrexafungerp?

A: SCYNEXIS is eligible for development, regulatory approval, commercial, and sales milestones from GSK, with a total potential value of $448 million plus royalties.

Q: What is the current cash runway for SCYNEXIS?

A: As of September 30, 2024, SCYNEXIS has a projected cash runway into Q3 2026.

Q: Are there any ongoing clinical trials for ibrexafungerp?

A: Yes, ibrexafungerp is currently undergoing phase II and phase III clinical trials for various indications, including invasive candidiasis and aspergillosis.

Q: What are the potential challenges facing the commercialization of ibrexafungerp?

A: One of the challenges includes the potential cross-contamination of ibrexafungerp drug substance with a non-antibacterial beta-lactam compound, which has delayed commercialization and further clinical development.

Cited Sources

  1. Ibrexafungerp: A novel oral glucan synthase inhibitor - Academic.oup.com
  2. SCYNEXIS Reports Third Quarter 2024 Financial Results and ... - IR.Scynexis.com
  3. SCYNEXIS Reports Full Year 2023 Financial Results and Provides ... - IR.Scynexis.com
  4. NDA Multi-Disciplinary Review and Evaluation - FDA - FDA.gov
  5. SCYNEXIS Reports Fourth Quarter and Full Year 2021 Financial ... - Biospace.com

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