ORLADEYO Drug Patent Profile

Which patents cover Orladeyo, and what generic alternatives are available?

Orladeyo is a drug marketed by Biocryst and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-one patent family members in thirty-eight countries.

The generic ingredient in ORLADEYO is berotralstat hydrochloride. One supplier is listed for this compound. Additional details are available on the berotralstat hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Orladeyo

Orladeyo was eligible for patent challenges on December 3, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2040. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ORLADEYO

International Patents:	91
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	1
Patent Applications:	2
Drug Prices:	Drug price information for ORLADEYO
What excipients (inactive ingredients) are in ORLADEYO?	ORLADEYO excipients list
DailyMed Link:	ORLADEYO at DailyMed

See drug prices for ORLADEYO

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

NDA:

214094

Dosage:

CAPSULE;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 ORLADEYO

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

Sponsor	Phase
BioCryst Pharmaceuticals	Phase 3

See all ORLADEYO clinical trials

Pharmacology for ORLADEYO

Drug Class	Plasma Kallikrein Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Kallikrein Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for ORLADEYO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORLADEYO	Capsules	berotralstat hydrochloride	110 mg and 150 mg	214094	1	2024-12-03

US Patents and Regulatory Information for ORLADEYO

ORLADEYO is protected by ten US patents and three FDA Regulatory Exclusivities.

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
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No					Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes					Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No					Y

International Patents for ORLADEYO

When does loss-of-exclusivity occur for ORLADEYO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Peru

Philippines

Singapore

South Korea

Taiwan

Uruguay

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 ORLADEYO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20210087037
Canada	2941380
Japan	2021169499
Japan	2023181543

Supplementary Protection Certificates for ORLADEYO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3113772	122021000062	Germany		PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	CA 2021 00040	Denmark		PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	132021000000164	Italy		PRODUCT NAME: BEROTRALSTAT E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(ORLADEYO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1544/001-002, 20210504
3113772	PA2021524	Lithuania		PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430

Market Dynamics and Financial Trajectory for ORLADEYO: A Strategic Analysis

Last updated: July 28, 2025

Introduction

ORLADEYO (berotralstaut), developed by BioCryst Pharmaceuticals, represents a pioneering oral therapy targeting hereditary angioedema (HAE). As a selective plasma kallikrein inhibitor, ORLADEYO fills a crucial niche within the HAE management landscape, promising efficacy, convenience, and improved patient adherence. This analysis evaluates the core market drivers, competitive forces, regulatory landscape, and projected financial trajectory shaping ORLADEYO’s commercial future.

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Market Overview and Therapeutic Positioning

Hereditary angioedema is a rare genetic disorder characterized by recurrent and potentially life-threatening swelling episodes. The global HAE market's valuation was approximately $800 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8% through 2030, primarily driven by increased diagnosis, expanding indications, and novel therapies [1].

ORLADEYO positions as an oral prophylactic and on-demand treatment, diverging from the traditionally injectable therapies, such as plasma-derived or recombinant C1 inhibitors (e.g., Takhzyro, launched by Takeda). Its oral route enhances patient convenience, adherence, and overall quality of life, critical factors influencing market acceptance.

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Market Drivers

1. Unmet Medical Need and Market Penetration

Despite the availability of injectable HAE treatments, gaps persist in patient adherence and quality of life, fueling demand for oral options. ORLADEYO’s oral bioavailability and rapid onset bolster its potential to capture a sizable share of prophylactic and on-demand segments.

2. Regulatory Milestones and Approvals

The U.S. Food and Drug Administration (FDA) approved ORLADEYO in August 2020 for the prophylaxis of HAE attacks in adults and adolescents aged 12 years and above. Subsequently, the European Medicines Agency (EMA) granted approval in 2021, expanding access across key markets.

3. Pricing and Reimbursement Dynamics

Pricing strategy plays a vital role. ORLADEYO's list price, set at approximately $15,000 per month, aligns with other biologic agents but benefits from its oral formulation's perceived value. Reimbursement negotiations hinge on demonstrating clinical efficacy, safety, and cost-effectiveness—factors currently favoring its market inclusion, given positive trial data.

4. Advancements in Clinical Practice and Diagnostics

Increased awareness and improved diagnostics for HAE drive diagnoses upward, enlarge the patient pool, and facilitate earlier treatment initiation. This trend enhances ORLADEYO’s potential market penetration.

5. Competitive Landscape and Differentiation

While other oral HAE therapies, such as cinryze (intravenous) and newer agents, exist, ORLADEYO’s unique mechanism and ease of use distinguish it. As additional oral products enter the pipeline, continued differentiation and clinical validation will be pivotal.

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Competitive Factors and Market Challenges

1. Existing Market Entrants

Takhzyro (ikyra, by Takeda) and Haegarda (C1 esterase inhibitor, by CSL Behring) dominate current prophylactic regimes, with established dosing regimens and clinician familiarity. ORLADEYO must demonstrate superior or at least comparable efficacy and safety to gain market share.

2. Cost and Pricing Pressures

Reimbursement authorities emphasize cost-effectiveness. While the high price can be justified by convenience and improved adherence, payers may push for price reductions or formulary restrictions, constraining revenue potential.

3. Patent Life and Generic Threats

Patent protections extend through 2030, safeguarding exclusivity. However, generic or biosimilar competition post-2191 expiry could erode market share, especially if biosimilar entrants emerge rapidly and are cost-advantageous.

4. Off-Label and Alternative Treatments

Emerging therapies targeting the kallikrein-kinin pathway and gene editing approaches could disrupt the existing treatment paradigm, influencing long-term market dynamics.

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Financial Trajectory and Revenue Projections

1. Initial Adoption and Growth Phases (2020-2025)

BioCryst estimates global sales of ORLADEYO at approximately $50 million in 2022, with a projected CAGR of 35-40% over the next three years, driven by expanding indications and increased market penetration [2]. The strong uptake in the U.S. initially will likely be complemented by gradual European adoption.

2. Expansion and Market Penetration (2025-2030)

By 2030, sales could surpass $500 million globally, with North America remaining dominant due to higher diagnosis rates and reimbursement structures. Continued clinical data demonstrating long-term safety and efficacy will bolster payer confidence, expanding access and prescriptions.

3. Commercial Strategy and Partnerships

BioCryst’s approach, including direct sales, strategic alliances, and academic collaborations, influences revenue streams. Training and educational initiatives targeting physicians can accelerate prescription rates. Negotiation of favorable formulary placements will be critical in sustaining growth.

4. Cost Structure and R&D Investment

Research & development expenses, notably for ongoing clinical trials and pipeline expansion, will impact profit margins initially. As market share solidifies, operational efficiencies should improve profitability.

5. Pricing Flexibility and Market Share Optimization

Price adjustments, volume discounts, and differentiated service offerings will shape future revenues. Performance-based reimbursement models could emerge, tying payment to clinical outcomes, aligning incentives and reducing payer risk.

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Regulatory and Market Entry Considerations

The regulatory landscape favors orphan drugs like ORLADEYO, offering incentives such as market exclusivity, fee waivers, and fast-track approval pathways [3]. However, navigating international approval processes necessitates localized clinical data and strategic engagement.

Potential market entry barriers include stringent reimbursement policies, supply chain complexities, and clinician familiarity with established therapies. Building broad clinical evidence and fostering early adoption will be vital.

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Emerging Trends and Outlook

The HAE therapeutics market is poised for continued evolution, with precision medicine, gene therapies, and novel kallikrein inhibitors potentially reshaping treatment paradigms. ORLADEYO’s positioning as an oral, targeted therapy gives it a strategic edge, provided it sustains clinical and commercial momentum.

The focus on compassionate access, patient-centered care, and healthcare cost containment will influence future market dynamics. BioCryst’s pipeline expansion, including innovative formulations and combination therapies, could diversify its revenue streams, hedging against competitive threats.

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Key Takeaways

• Market Expansion Opportunities: Increasing diagnosis rates and a preference for oral HAE therapies support robust growth prospects for ORLADEYO, with projected sales exceeding $500 million globally by 2030.

• Competitive and Pricing Strategies: Maintaining clinical superiority, optimizing pricing, and securing favorable formulary access are vital to capturing and expanding market share.

• Regulatory and Reimbursement Environment: Ongoing regulatory approvals and payer negotiations will critically influence revenue trajectories, emphasizing the importance of demonstrating long-term safety and cost-effectiveness.

• Pipeline and Innovation: BioCryst’s ongoing clinical trials and pipeline development are key to sustaining growth amid evolving competitive pressures, including potential gene therapies and emerging oral agents.

• Risk Management: Patent cliffs, biosimilar competition, and emerging treatment options introduce risks. Strategic investments in clinical validation, market education, and international expansion are essential.

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FAQs

1. What makes ORLADEYO distinct from other HAE treatments?
ORLADEYO offers an oral, selective plasma kallikrein inhibitor, providing a convenient alternative to injectable therapies like C1 esterase inhibitors, potentially improving compliance and quality of life.

2. How does the current reimbursement landscape affect ORLADEYO’s market potential?
While initial reimbursement has been supportive, payers are increasingly emphasizing cost-effectiveness, which could influence formulary placement, pricing, and access, especially as competition intensifies.

3. What are the primary challenges facing ORLADEYO’s adoption?
Key challenges include competition from established injectable therapies, payer pricing pressures, and the need for extensive clinician education to shift prescribing habits toward oral options.

4. What is the outlook for ORLADEYO’s sales growth over the next five years?
Sales are expected to grow at a CAGR of approximately 35-40%, potentially reaching over $500 million globally by 2030, supported by expanding indications and geographic markets.

5. How might emerging therapies impact ORLADEYO’s long-term financial trajectory?
Innovative treatments, including gene therapies, may threaten market share but also present opportunities for collaboration and pipeline diversification. Continuous clinical differentiation and strategic planning are essential for sustained success.

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Sources

1. Grand View Research. (2022). Hereditary Angioedema Market Size, Share & Trends Analysis, 2022-2030.
2. BioCryst Pharmaceuticals. (2022). Annual Report 2022.
3. FDA. (2020). Approval documents for ORLADEYO.