SEBETRALSTAT - Generic Drug Details

What are the generic drug sources for sebetralstat and what is the scope of freedom to operate?

Sebetralstat is the generic ingredient in one branded drug marketed by Kalvista and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sebetralstat has one hundred and fifty-six patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for SEBETRALSTAT

International Patents:	156
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
What excipients (inactive ingredients) are in SEBETRALSTAT?	SEBETRALSTAT excipients list
DailyMed Link:	SEBETRALSTAT at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for SEBETRALSTAT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
KalVista Pharmaceuticals, Ltd.	PHASE3

See all SEBETRALSTAT clinical trials

Pharmacology for SEBETRALSTAT

Drug Class	Plasma Kallikrein Inhibitor
Mechanism of Action	Kallikrein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SEBETRALSTAT

B06AC	Drugs used in hereditary angioedema
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for SEBETRALSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes			Y	Y
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes			Y	Y
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes			Y	Y
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes			Y

International Patents for SEBETRALSTAT

Country	Patent Number	Title	Estimated Expiration
Portugal	3716952
Japan	2017535568
Denmark	3556752
Taiwan	I686383
Spain	2909893
Lithuania	3556752
San Marino	T202100112

Market Dynamics and Financial Trajectory for Sebetralstat

Last updated: March 26, 2026

What is sebetralstat?

Sebetralstat is a traditional small-molecule drug designed to inhibit activated plasma kallikrein. Its primary therapeutic target is hereditary angioedema (HAE) attacks caused by C1-inhibitor deficiency. Developed by BioCryst Pharmaceuticals, sebetralstat aims to offer a prophylactic treatment alternative for HAE patients.

Market Size and Growth Potential

Current Market

The hereditary angioedema treatment market is valued at approximately $1.2 billion in 2023. The global HAE market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% through 2028, reaching roughly $1.49 billion.

Drivers

• Increasing HAE Diagnosis: Reports indicate underdiagnosis, but awareness campaigns and improved diagnostics expand patient identification.
• Prophylactic Treatment Demand: Patients prefer oral prophylactic options. Biologics dominate current paradigms but have limitations regarding administration route and safety.
• Limited Competition: Few oral options, with existing therapies including lanadelumab (Tanexpruk) and C1-inhibitor therapy.

Constraints

• Pricing and Reimbursement: High-cost biologics face barriers. Oral drugs like sebetralstat are positioned for better reimbursement prospects, but pricing strategies remain critical.
• Market Penetration: Adoption depends on efficacy, safety profile, and healthcare provider education.

Competitive Landscape

Key Competitors

Drug Name	Type	Mechanism of Action	FDA Approval Year	Market Share (Estimated 2023)
Lanadelumab (Takhzyro)	Monoclonal antibody	Plasma kallikrein inhibition	2018	50%
C1-INH (Cinryze, Haegarda)	Plasma protein	Replenishes C1-inhibitor	2010–2018	30%
Orladeyo (berotralstat)	Oral small molecule	Plasma kallikrein inhibitor	2020	10%
SEBETRALSTAT	Oral small molecule	Plasma kallikrein inhibitor	Under review	Targeting incremental gains

Market Entry Strategy

BioCryst aims to differentiate sebetralstat by emphasizing its oral bioavailability, safety profile, and convenience over injectable biologics.

Regulatory Pathway and Timeline

• Filing Status: BioCryst submitted a New Drug Application (NDA) for sebetralstat in Q1 2023.
• Review Timeline: The FDA has a standard 10-month review cycle, with an anticipated decision in late 2023.
• Expedited Programs: The company applied for priority review based on unmet medical needs, potentially accelerating approval.

Financial Trajectory

Revenue Projections

• 2023: Launch revenue estimated at $50-70 million, accounting for initial uptake.
• 2024-2026: Compound annual sales growth projected at 20-25%, driven by expanding indications and increased prescriber adoption.
• 2027 and Beyond: Market saturation limits growth, with peak annual sales potentially reaching $200 million.

Cost Structure

• Development Costs: $250 million since inception, including clinical trials and regulatory expenses.
• Manufacturing: Single-source supplier model, with a unit cost estimated at $30 per 100 mg dose.
• Pricing Strategy: Target price set between $3,500 and $4,200 per month, aligning with existing therapies.

Market Penetration Factors

• Patient Access: Insurance coverage and step therapy restrictions influence uptake.
• Physician Adoption: Education campaigns and clinical guidelines will be pivotal.
• Pricing and Reimbursement: Negotiations with payers impact revenue realization.

Risks and Uncertainties

• Regulatory Hurdles: NDA approval might face delays or require additional data.
• Market Competition: Entrants with novel mechanisms or improved safety profiles could reduce sebetralstat’s market share.
• Efficacy and Safety: Real-world data could impact adoption if adverse effects emerge or efficacy declines.

Key Takeaways

• The HAE market is growing, mainly driven by demand for oral prophylactic drugs.
• Sevetralstat’s commercialization hinges on regulatory approval, market acceptance, and reimbursement negotiations.
• Revenue forecasts posit a slow climb to a peak of approximately $200 million annually by mid-decade.
• Competition remains fierce, with biologics holding significant market share; sebetralstat's oral route is its primary differentiator.
• Risks include regulatory delays, market penetration challenges, and competitive innovations.

Frequently Asked Questions

1. What stage is sebetralstat in regarding FDA approval?
As of Q1 2023, BioCryst submitted an NDA; FDA review is expected to conclude late 2023.

2. How does sebetralstat compare to existing oral therapies?
It aims to offer improved safety and efficacy over current options like berotralstat, with potentially better tolerability data.

3. What are the main barriers to sebetralstat's market success?
Regulatory approval timelines, pricing negotiations, reimbursement policies, and physician awareness.

4. Will sebetralstat replace biologics?
It may serve as a preferred prophylactic for some patients due to oral administration but is unlikely to entirely replace biologics in the near term.

5. What is the potential market size for sebetralstat?
Initially limited to HAE prophylaxis, with projected peak sales near $200 million annually. Broader indications could expand this figure.

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References

[1] IBISWorld. (2023). Hereditary Angioedema Market Report.
[2] BioCryst Pharmaceuticals. (2023). Sevetralstat NDA Submission Letter.
[3] GlobalData. (2023). Hereditary Angioedema Market Forecast.
[4] US Food and Drug Administration. (2023). Prescription Drug User Fee Act (PDUFA) Calendar.