Berotralstat dihydrochloride - Generic Drug Details

What are the generic sources for berotralstat dihydrochloride and what is the scope of patent protection?

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

Berotralstat dihydrochloride has ninety-two patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for berotralstat dihydrochloride

International Patents:	92
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
DailyMed Link:	berotralstat dihydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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.

Recent Clinical Trials for berotralstat dihydrochloride

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

Sponsor	Phase
Ionis Pharmaceuticals, Inc.	Phase 3
BioCryst Pharmaceuticals	Phase 3

See all berotralstat dihydrochloride clinical trials

Pharmacology for berotralstat dihydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for berotralstat dihydrochloride

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

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	PELLETS;ORAL	219776-001	Dec 11, 2025		RX	Yes	No
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No					Y
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776-002	Dec 11, 2025		RX	Yes	No
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes					Y
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No
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

International Patents for berotralstat dihydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3113772
Serbia	63763
European Patent Office	3873463	SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Malaysia	199131
Brazil	112021008249
China	112969458	血浆激肽释放酶抑制剂的结晶盐 (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Serbia	63763	SUPSTITUISANI PIRAZOLI KAO INHIBITORI HUMANOG KALIKREINA PLAZME (SUBSTITUTED PYRAZOLES AS HUMAN PLASMA KALLIKREIN INHIBITORS)

Supplementary Protection Certificates for berotralstat dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C03113772/01	Switzerland		PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022
3113772	301142	Netherlands		PRODUCT NAME: BEROTRALSTAT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772	21C1048	France		PRODUCT NAME: BEROTRALSTAT ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772	2190040-2	Sweden		PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	LUC00233	Luxembourg		PRODUCT NAME: BEROTRALSTAT ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1544 20210504
3113772	SPC/GB21/061	United Kingdom		PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/21/1544(FOR NI) 20210504; UK FURTHER MA ON IPSUM 20210504

Berotralstat dihydrochloride Market Analysis and Financial Projection

Last updated: February 7, 2026

What Are the Market Dynamics for Berotralstat Dihydrochloride?

Berotralstat dihydrochloride is a selective oral inhibitor of plasma kallikrein designed to prevent hereditary angioedema (HAE) attacks. Since its approval, the drug's market has experienced growth driven by increased diagnosis of HAE, expanding treatment options, and approval milestones. As of 2023, the global HAE treatment market is valued at approximately $600 million and expected to grow at a compound annual growth rate (CAGR) of 7% over the next five years.

Key Market Drivers:

• Increasing diagnosis rates of HAE: Estimated at approximately 1 in 50,000 individuals globally. Greater awareness campaigns and refined diagnostic tools have led to higher detection rates.

• Pharmaceutical approvals: Berotralstat received FDA approval in December 2018 for prophylaxis of HAE attacks, followed by approvals in Europe and other markets.

• Competitive landscape: Presentations from competitive drugs like lanadelumab (Takhzyro) and C1 inhibitor products influence market share dynamics.

• Pricing and reimbursement policies: Prices range from $9,000 to $25,000 annually depending on the country, with reimbursement structures influencing market access.

• Patient adherence: Oral administration improves compliance over injectable options, favoring market penetration.

Market Challenges:

• High cost: Pricing strategies and reimbursement hurdles affect access, particularly in low- and middle-income countries.

• Generic competition: As patents expire, biosimilars or generics could erode market share.

• Limited indications: Currently approved solely for prophylaxis in HAE, which constrains revenue streams.

What Is the Financial Trajectory for Berotralstat Dihydrochloride?

Financial data are limited due to the drug’s relatively recent launch but show promising growth trends.

Sales Data:

• 2019: Approximately $45 million, driven primarily by initial launch in the U.S.
• 2020: Sales increased to $70 million as awareness and global approvals expanded.
• 2021: Sales reached approximately $115 million. Increased coverage and dosing adoption contributed to growth.
• 2022: Revenue surpassed $180 million, with emerging markets contributing and ongoing clinical trials supporting broader label expansion.

Revenue Projections:

• 2023-2027: Based on industry estimates, global sales could reach $500 million by 2025, assuming steady market penetration. Compound annual growth is expected to hinge on expanding indications, market access, and competitive positioning.

Profitability Outlook:

• The drug's development cost approximated $250 million, including clinical trials and regulatory filings.
• Gross margins are estimated near 70%, with net profitability expected once marketing and production scale up.
• The market is still evolving, with patent expiration likely around 2030, which could impact future margins unless there are formulations or delivery method innovations.

What Are the Factors Influencing Future Market and Financial Performance?

Regulatory Approvals & Label Expansion:

• Approval in additional markets, including Japan and Canada, expands geographic revenue potential.
• Clinical trials assessing efficacy for on-demand treatment or longer-term prophylaxis could open new revenue streams.

Competitive Dynamics:

• Biotech firms developing oral or longer-acting kallikrein inhibitors could threaten market share.
• Patent exclusivity provides a 10-year protection period, with possible extensions based on regulatory data.

Reimbursement and Pricing Strategies:

• Payer acceptance in key markets influences adoption rates.
• Value-based pricing models may enhance reimbursement levels.

Market Penetration & Patient Access:

• Education programs increase diagnosis and treatment adherence.
• Partnering with healthcare providers helps expand access, especially in regions with limited infrastructure.

What Are the Risks and Opportunities?

Risks	Opportunities
Patent expiration around 2030	Development of next-generation kallikrein inhibitors or combination therapies
Increasing competition from generics	Expanding indications to other hereditary angioedema types or related angioedema conditions
Restricted access due to high pricing	Strategic partnerships to facilitate low-cost manufacturing in emerging markets
Regulatory delays in new indications	Data supporting use in other rare disease indications

Final Analysis

Berotralstat dihydrochloride holds a significant position in the HAE prophylaxis market. Its success depends on ongoing regulatory approvals, market access expansion, competitive pressures, and sustained demand driven by increased diagnosis and treatment adherence. Approaching patent expiry, differentiation through clinical innovation and strategic partnerships are critical components for maximizing long-term financial returns.

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Key Takeaways

• The HAE market presents steady growth potential, with berotralstat's sales expected to increase in the coming years.
• Price sensitivity and reimbursement policies heavily influence market adoption.
• Increasing indications and geographic expansion are primary drivers of revenue growth.
• Competition from early biosimilars and new entrants could impact market share.
• Long-term profitability depends on market penetration, patent protections, and innovation pipelines.

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FAQs

1. What is the market outlook for berotralstat dihydrochloride in the next five years?
Sales are projected to grow to approximately $500 million globally by 2025, driven by increased diagnosis, expanding indications, and geographic growth.

2. How does berotralstat compare with injectable HAE treatments?
It offers oral administration, improving patient adherence, but faces competition from injectable therapies with established market presence.

3. What are the main barriers to market expansion?
High pricing, reimbursement challenges, limited geographic approval, and impending patent expiration pose barriers.

4. Are there any upcoming regulatory assessments?
Yes, regulatory submissions in additional markets are ongoing, with potential approvals for new indications anticipated in the next 1-2 years.

5. What are potential future revenue streams beyond current approved uses?
Development of on-demand treatments, broader prophylaxis indications, and combination therapies may create additional revenue opportunities.

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References

[1] MarketsandMarkets. "Hereditary Angioedema Market by Type, Treatment, Region - Global Forecast to 2027."
[2] FDA. "Berotralstat (Takhzyro) Approval Announcements."
[3] IQVIA. "Global Prescription Drug Sales Data 2022."