berotralstat dihydrochloride - Profile

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What are the generic sources for berotralstat dihydrochloride and what is the scope of freedom to operate?

Berotralstat dihydrochloride is the generic ingredient in one branded drug marketed by Biocryst and is included in two NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for berotralstat dihydrochloride

International Patents:	94
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for berotralstat dihydrochloride

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

Dosage:

PELLETS;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.

Paragraph IV (Patent) Challenges for BEROTRALSTAT DIHYDROCHLORIDE

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

US Patents and Regulatory Information for berotralstat dihydrochloride

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

International Patents for berotralstat dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2015226855
Australia	2020260400
Australia	2022259742
Brazil	112016020199
Canada	2941380
Canada	3164693

Supplementary Protection Certificates for berotralstat dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3113772	21C1048	France		PRODUCT NAME: BEROTRALSTAT ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772	C03113772/01	Switzerland		PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022
3113772	C202130056	Spain		PRODUCT NAME: BEROTRALSTAT Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1544; DATE OF AUTHORISATION: 20210430; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1544; DATE OF FIRST AUTHORISATION IN EEA: 20210430
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	301142	Netherlands		PRODUCT NAME: BEROTRALSTAT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772	202140032	Slovenia		PRODUCT NAME: BEROTRALSTAT AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; NATIONAL AUTHORISATION NUMBER: EU/1/21/1544; DATE OF NATIONAL AUTHORISATION: 20210430; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Berotralstat Dihydrochloride: Investment Scenario and Fundamentals Analysis

Last updated: February 10, 2026

Overview

Berotralstat dihydrochloride (brand name: Orladeyo) is a small-molecule oral medication developed by BioCryst Pharmaceuticals. It acts as a selective inhibitor of plasma kallikrein, reducing hereditary angioedema (HAE) attacks. Approved by the FDA in December 2020, it targets a niche but high-value market segment.

Market Position and Commercial Dynamics

• Indication: Prophylactic treatment for preventing hereditary angioedema attacks in adults and adolescents.
• Patient Need: HAE affects approximately 1 in 50,000 people globally, predominantly in developed markets.
• Market Size: The global HAE market was valued at around $1.8 billion in 2022 and is projected to grow at approximately 6-8% annually.
• Competitive Landscape: Only two drugs have extensive approval, with additional agents in pipeline:
  • Berotralstat: Oral, once daily.
  • C1 Esterase Inhibitors: Intravenous or subcutaneous, such as lanadelumab.
  • Potential pipeline drugs targeting similar pathways.

Financial Fundamentals

• Pricing and Revenue: In the U.S., priced around $7,800 per month. BioCryst reported 1,949 patients on therapy by end 2022, translating to revenue around $180 million in 2022.
• Growth Trends: Revenues increased approximately 40% from 2021 to 2022, driven by increased prescriptions and market penetration.
• Cost Structure: R&D expenses remain substantial, with continued investment in pipeline and label expansion; SG&A expenses are moderate, focused on sales and marketing.

Regulatory and Reimbursement Landscape

• FDA Approval: Secured in December 2020 based on pivotal trials demonstrating efficacy.
• European and Other Approvals: Filed for approval in Europe and other regions; approval timelines may extend into 2024.
• Reimbursement: Coverage remains favorable in key markets, supported by demonstrated clinical benefit and quality of life improvements, influencing patient access and revenue stability.

Pipeline and Expansion Potential

• Label Expansion: Clinical trials ongoing for pediatric indications and outpatient management, potentially broadening the market.
• Market Penetration: Limited in regions outside the U.S; expansion could accelerate revenue growth if regulatory approvals are achieved.
• New Formulations: Research into injectable forms and combination therapies remains in early stages.

Competitive Risks

• Market Saturation: Limited number of approved prophylactic agents restricts competitive pressure but could change as pipeline drugs advance.
• Pricing Pressures: Reimbursement negotiations and cost-containment measures threaten margins.
• Pipeline Risks: Failure to secure approvals or demonstrate comparative benefit could reduce future revenue prospects.

Investment Risks

• Regulatory Risk: Potential delays or rejections in new markets.
• Market Adoption: Physician preference for existing therapies or delays in prescribing behavior.
• Patent Lifecycle: Patent expiry in the early to mid-2030s, with biosimilar or generic entrants possible thereafter.

Valuation Considerations

• Revenue Forecasts: Based on market penetration, drug price, and pipeline expansion.
• Discounted Cash Flow (DCF): Models suggest moderate upside assuming continued growth and expansion, but with significant sensitivity to market uptake and pricing.
• Comparable Analysis: Similar emerging therapies show valuation multiples between 10-15x sales, though mature niche drugs often trade at lower multiples.

Key Takeaways

Berotralstat dihydrochloride is positioned as a targeted oral therapy in a niche but growing market. Its success hinges on continued market penetration, approval expansion, and the absence of stronger competitive threats. Current financials reflect a growing sales base with substantial R&D and commercialization investments. Investors should monitor pipeline progress, regulatory developments, reimbursement policies, and competitive dynamics.

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FAQs

1. What is the primary therapeutic advantage of berotralstat?
It offers an oral, once-daily prophylactic option for hereditary angioedema, providing convenience outside of injectable therapies.

2. How does berotralstat's market share compare to existing treatments?
It is competing primarily with injectable agents like lanadelumab, with market penetration increasing as physicians and patients adopt oral options.

3. What regulatory hurdles remain for berotralstat?
Pending approvals in Europe and other regions; potential delays or rejections could impede global market expansion.

4. What are the main factors driving revenue growth?
Increased prescription volumes, broader insurance coverage, and potential label expansions.

5. What are the key risks for investors?
Market penetration challenges, pricing pressures, pipeline setbacks, and emerging competitors.

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Sources

1. BioCryst Pharmaceuticals SEC filings and annual reports.
2. FDA approval documents for Orladeyo.
3. Market research reports on hereditary angioedema.
4. European Medicines Agency submissions.
5. Industry coverage from Bloomberg and EvaluatePharma.