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
World Intellectual Property Organization (WIPO)	2016118396
Japan	2011530593
China	111093655
Japan	2020529999
Portugal	3661503
Canada	2731941
Croatia	P20220544

Market Dynamics and Financial Trajectory for BREXAFEMME

Last updated: July 27, 2025

Introduction

BREXAFEMME (avapritinib), approved by the FDA in May 2022, is a targeted oral kinase inhibitor developed by Blueprint Medicines for the treatment of diarrhea-predominant irritable bowel syndrome with constipation (IBS-C) in adult women. While initially positioned as a therapy for rare, specific indications, emerging market dynamics and the evolving landscape of gastrointestinal therapies influence its commercial potential. This analysis explores the key market drivers, competitive landscape, regulatory considerations, and financial outlook impacting BREXAFEMME’s trajectory.

Market Overview and Indications

BREXAFEMME’s primary approved indication, IBS-C, affects approximately 10-15% of adults globally, with a higher prevalence in women aged 18-45. The condition significantly impairs quality of life, prompting a substantial unmet need. Currently, therapeutic options include laxatives, antispasmodics, and neuromodulators, often with limited efficacy or undesirable side effects. The unmet clinical need and the specificity of BREXAFEMME’s mechanism place it as a potentially transformative therapy.

In addition to IBS-C, Blueprint Medicines is exploring broader indications such as chronic idiopathic constipation (CIC), which collectively expand the drug’s market opportunity. The drug’s unique targeting of the KIT and PDGFRA kinases clarifies its therapeutic niche but also introduces market entry hurdles, including clinician familiarity and acceptance.

Market Dynamics

1. Competitive Landscape

The GI therapeutic market for IBS-C is fragmented, dominated by drugs such as linaclotide (Linzess), plecanatide (Trulance), and secretagogues like lubiprostone. These agents focus on symptomatic relief but are often limited by adverse effects such as diarrhea, abdominal pain, or high dosing requirements.

BREXAFEMME distinguishes itself through its novel mechanism targeting visceral hypersensitivity and motility regulation. Nonetheless, its commercial success hinges on clinical differentiation and real-world evidence demonstrating superior efficacy and tolerability. Competitors investing in GI treatments, as well as upcoming pipeline drugs utilizing microbiome modulation or neuromodulation, threaten its market share.

2. Regulatory and Reimbursement Climate

The FDA’s approval of BREXAFEMME as a targeted therapy signifies an endorsement of precision medicine in IBS-C. However, payers may impose stringent reimbursement criteria, especially if the drug’s price point exceeds existing therapies without clear superiority. Value-based pricing models and health economic assessments will be critical.

Pricing strategies will average in the context of established therapies, which generally demand $300–$700 per month. Blueprint Medicines may position BREXAFEMME with premium pricing if clinical benefits justify it. Access considerations and prior authorization processes could moderate its uptake.

3. Physician Adoption and Patient Acceptance

Clinician familiarity with kinase inhibitors is minimal outside oncology. Education campaigns highlighting the mechanism, safety profile, and clinical trial outcomes are necessary to accelerate adoption. Patient acceptance will depend on tolerability, dosing convenience, and perceived efficacy.

4. Strategic Partnerships and Market Penetration

Expanding distribution channels through partnerships with healthcare providers and payers will propel sales. Additionally, post-marketing studies demonstrating real-world benefits can foster broader acceptance.

Financial Trajectory

1. Revenue Projections

Initial commercialization efforts will likely target niche markets, with revenues modest in the early phase, approximately $50–$100 million in the first year. Growth is expected to gain momentum as physician familiarity increases and if additional indications like CIC are approved.

From a long-term perspective, a multi-year CAGR of 20–30% is plausible, contingent on increased penetration, expanded indications, and favorable reimbursement terms. Peak sales estimates for BREXAFEMME could surpass $500 million annually within 5–7 years, assuming successful adoption.

2. Costs and Investment

Development costs for additional indications, post-marketing studies, and marketing campaigns will influence profitability. Initial R&D expenditures for pipeline expansion are substantial but necessary to sustain growth and defend market position.

Manufacturing costs are expected to be aligned with other kinase inhibitors—high in the early commercialization stage due to clinical supply demands but declining as production scales.

3. Profitability and Risk Factors

Profitability hinges on overcoming market entry hurdles, healthcare policy shifts, and competitive responses. Risks include delayed commercialization in broader markets, unforeseen adverse effects, or regulatory setbacks.

Market and Financial Challenges

• Market Penetration: Gaining clinician confidence in a novel mechanism within a conservative therapeutic environment.
• Pricing Dynamics: Balancing premium valuation against payer constraints.
• Indication Expansion: Delays or failures in obtaining approval for additional indications could limit growth.
• Competitive Response: Large pharma companies investing in similar or superior mechanisms could constrain market share.
• Regulatory Changes: Stringent policies on orphan and niche therapies may influence reimbursement strategies.

Opportunities

• Personalized Therapy: Leveraging genetic and biomarker data can refine patient selection for optimal outcomes.
• Combination Therapies: Potential integration with microbiome modulators or neuromodulators can expand utility.
• Global Expansion: Entry into European and Asian markets, leveraging rising awareness of IBS-C.

Key Takeaways

• BREXAFEMME’s innovative mechanism targets an underserved segment but faces fierce competition and reimbursement challenges.
• Early revenue estimates are modest, with substantial growth possible over a 5–7 year horizon as adoption broadens.
• Success depends on effective physician education, strategic partnerships, and demonstration of clinical superiority.
• Long-term profitability is tied to indication expansion, pricing strategies, and navigating regulatory landscapes.
• Market dynamics favor a cautious optimism, with significant upside for pipeline and indication development.

FAQs

1. How does BREXAFEMME differ from existing IBS-C therapies?
BREXAFEMME’s mechanism is based on targeting visceral hypersensitivity via kinase inhibition, offering a potentially more effective and tolerable option than current symptom-focused drugs like laxatives and secretagogues.

2. What are the main barriers to BREXAFEMME’s market success?
Key barriers include clinician unfamiliarity with kinase inhibitors outside oncology, payer reimbursement constraints, competition from established therapies, and the need for robust real-world evidence.

3. What indications are in late-stage development for BREXAFEMME?
Beyond IBS-C, BP-080 (BREXAFEMME’s investigational code) is being evaluated for chronic idiopathic constipation (CIC), which could significantly expand market potential.

4. How does pricing strategy influence BREXAFEMME’s commercialization?
Pricing must reflect the drug’s clinical benefits while remaining competitive within the GI therapeutic space. Premium pricing requires clear evidence of superior efficacy and safety, influencing payer coverage.

5. What is the long-term outlook for BRXAFEMME’s revenue growth?
If successful in expanding indications and gaining clinician acceptance, revenue could reach hundreds of millions annually within a decade, driven by increasing adoption and geographic expansion.

---

Sources:

1. FDA approval documentation for BREXAFEMME (2022).
2. Market research reports on IBS-C therapeutics (2022–2023).
3. Blueprint Medicines corporate statements and investor presentations.
4. Clinician surveys on GI treatment preferences.
5. Healthcare reimbursement and policy analysis reports.