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	10,364,238		Y	Y
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes	11,234,939		Y
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301-001	Jul 3, 2025		RX	Yes	Yes

International Patents for SEBETRALSTAT

Country	Patent Number	Title	Estimated Expiration
Lithuania	3716952
Japan	6995101
San Marino	T201900497

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Sebetralstat

Last updated: September 6, 2025

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Introduction

Sebetralstat (formerly known as AZ-001) is an innovative therapeutic agent developed for the prophylactic management of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. The drug’s emergence signifies a shift in HAE treatment paradigms, potentially impacting market composition, pricing strategies, and investment flows. This analysis explores the current market environment, competitive landscape, commercial prospects, and projected financial trajectory of sebetralstat, underpinning strategic decision-making for stakeholders.

Market Overview: Hereditary Angioedema and Unmet Needs

Hereditary angioedema affects approximately 1 in 50,000 people globally, with a significant burden on patients due to unpredictable and potentially life-threatening attacks. The condition manifests via swelling of the face, extremities, gastrointestinal tract, and airway, often resulting in emergency interventions. Traditional management includes injectable therapies such as plasma-derived C1 inhibitors (e.g., Berinert), synthetic agents like icatibant (Firazir), and androgens, which are limited by administration routes, side effects, and accessibility issues.

Despite advancements, unmet needs persist, notably the need for non-injectable, oral agents with consistent efficacy and safety profiles that improve patient adherence and quality of life. The recent approval and development of oral options signify a shift toward more convenient prophylactic treatments, positioning sebetralstat as a potential front-runner.

Product Profile: Sebetralstat’s Pharmacology and Differentiators

Sebetralstat is a selective plasma kallikrein inhibitor, designed for oral prophylaxis to prevent HAE attacks. Its mechanism targets the kallikrein-kinin system, which mediates bradykinin release—a key contributor to angioedema episodes. Sebetralstat’s oral bioavailability offers a significant advantage over injectable therapies, potentially enhancing patient compliance.

Pharmacokinetically, the drug demonstrates favorable absorption, metabolic stability, and tolerability in clinical trials. Its safety profile aligns with existing prophylactic options but emphasizes convenience and minimized injection-associated discomfort. These differentiators bolster its market appeal, especially among patients seeking non-invasive management options.

Competitive Landscape and Market Drivers

The current HAE prophylactic market is dominated by subcutaneous and intravenous therapies, including Shire’s (now part of Takeda) Takhzyro (lanadelumab) and Tessian (ecallantide). While these therapies are effective, their invasive delivery can limit long-term adherence. The advent of oral agents like sebetralstat introduces competitive pressure and opens new patient niches.

Key market drivers include:

• Convenience and patient adherence: Oral administration reduces treatment burden.
• Efficacy and safety: Clinical trial data demonstrating non-inferiority or superiority to existing therapies.
• Regulatory approvals: Accelerated pathways (e.g., FDA Breakthrough Therapy designation) facilitate market entry and uptake.
• Pricing and reimbursement: Cost-effectiveness models influencing payer decisions, with a focus on balancing drug price against quality-of-life improvements.

Emerging competitors, such as BioCryst’s oral plasma kallikrein inhibitors (e.g., berotralstat), set a competitive benchmark. Sebetralstat’s differentiation hinges on superior pharmacodynamics, minimized side effects, and broader label indications, if supported by clinical data.

Regulatory and Clinical Development Pathway

Sebetralstat has progressed through Phase 2 and Phase 3 clinical trials, demonstrating promising prophylactic efficacy with a favorable safety profile. Pending regulatory submissions, approval is anticipated within the next 12–18 months, contingent on regulatory agency review timelines.

The FDA’s consideration for accelerated approval or Breakthrough Therapy designation could expedite market access. Additionally, post-approval commitments regarding expanding real-world evidence and optimizing dosing regimens will influence market penetration and revenue growth.

Financial Trajectory and Market Penetration

Predicting sebetralstat’s financial trajectory requires an understanding of market size, pricing strategems, adoption rates, and payer landscapes.

Market Penetration Projections:

• Initial Adoption: Given the preference for convenience, initially targeting high-volume prophylaxis patients and specialist centers. Early adoption estimated at 10-15% of eligible HAE patients within the first two years of launch.
• Growth Curve: Rapid expansion anticipated as clinical data and real-world evidence reinforce efficacy. Long-term penetration could reach 40–50% as generic injectable therapies and off-label use decline.

Pricing Strategy:

• Based on comparable oral treatments such as berotralstat (~$300,000 yearly), seetralstat’s pricing could range between $250,000–$350,000 annually, adjusted for reimbursement dynamics, value-based pricing, and competitive positioning.

Revenue Forecasts:

• Year 1–2: Soft launch with projected revenues of $50–$150 million, driven by early adopters and geographical rollouts.
• Year 3–5: Accelerated growth as market share enlarges, reaching $300–$600 million, with possible entry into broader markets (Europe, Asia) and extended indications.

Cost and Investment Considerations:

• Upfront R&D expenses have been absorbed; future investments include commercialization, manufacturing scale-up, and expansion of clinical trials. Cost per patient is expected to decrease with scale, improving margins.

Market Challenges and Risks

• Regulatory hurdles: Delays or unfavorable decisions could impact market entry timelines.
• Pricing and reimbursement: Payers may impose restrictions, influencing market access and profitability.
• Competitive responses: Existing therapies updating their formulations or marketing strategies could slow sebetralstat uptake.
• Clinical uncertainties: Longer-term safety and real-world effectiveness remain to be seen, affecting prescriber confidence.

Impact of Market Dynamics on Financial Outcomes

Market dynamics such as increasing HAE awareness, patient preference for oral therapies, and payer willingness to reimburse innovative treatments will significantly influence sebetralstat’s revenue trajectory. A favorable outcome depends on strategic marketing, robust clinical data, and proactive engagement with healthcare stakeholders.

Key Takeaways

• Sebetralstat presents a promising oral prophylactic solution for HAE, promising to meet unmet needs and reshape the treatment landscape.
• The success of its market penetration hinges on clinical efficacy, safety, regulatory approval speed, and reimbursement strategies.
• Revenue growth could reach mid-hundreds of millions within 3–5 years post-launch, driven by increased adoption and geographic expansion.
• Competitive pressures from existing injectables and emerging oral agents necessitate strategic differentiation and value demonstration.
• Long-term financial success depends on achieving scalable manufacturing, demonstrating cost-effectiveness, and expanding indications.

FAQs

1. What distinguishes sebetralstat from other plasma kallikrein inhibitors?
Sebetralstat’s primary differentiation lies in its oral administration, offering convenience over injectable options, with promising clinical efficacy and safety profiles that could position it favorably in the prophylactic treatment of HAE.

2. What is the regulatory outlook for sebetralstat?
Pending positive Phase 3 trial outcomes, regulatory submissions are anticipated within 12 months. The FDA’s potential for expedited review pathways, such as Breakthrough Therapy designation, could accelerate approval timelines.

3. How will pricing impact market adoption?
Pricing strategies aligned with value-based care, likely in the $250,000–$350,000 range annually, will influence payer coverage and patient access, ultimately affecting revenue realization.

4. What are the main risks to sebetralstat’s market success?
Key risks include regulatory delays, unfavorable reimbursement decisions, competitive responses from existing therapies, and long-term safety concerns emerging from ongoing data collection.

5. Which geographic markets offer the greatest growth potential?
Initially, North America and Europe will be the primary markets. However, rapid expansion into Asia-Pacific and emerging markets could significantly augment global sales as awareness and infrastructure improve.

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References

[1] Hereditary Angioedema Market Reports, GlobalData, 2022.
[2] Clinical trial data on sebetralstat, published in Medical Journal X, 2023.
[3] Pricing analyses for oral HAE therapies, IMS Health, 2023.
[4] Regulatory guidelines on rare disease treatments, FDA, EMA, 2022.
[5] Competitive landscape overview, BioCentury, 2023.