BEVYXXA Drug Patent Profile

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

Bevyxxa is a drug marketed by Portola Pharms Inc and is included in one NDA. There are five patents protecting this drug.

This drug has sixty-seven patent family members in twenty-six countries.

The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.

DrugPatentWatch^® Generic Entry Outlook for Bevyxxa

Bevyxxa was eligible for patent challenges on June 23, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 29, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BEVYXXA

International Patents:	67
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	112
Patent Applications:	734
Drug Prices:	Drug price information for BEVYXXA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEVYXXA
DailyMed Link:	BEVYXXA at DailyMed

See drug prices for BEVYXXA

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

NDA:

208383

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.

US Patents and Regulatory Information for BEVYXXA

BEVYXXA is protected by six US patents.

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
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017		DISCN	Yes	No
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017		DISCN	Yes	No				Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017		DISCN	Yes	No			Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No			Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No

Expired US Patents for BEVYXXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017

EU/EMA Drug Approvals for BEVYXXA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Portola Pharma UK Limited	Dexxience	betrixaban	EMEA/H/C/004309Prevention of venous thromboembolism	Refused	no	no	no		2018-09-20

International Patents for BEVYXXA

When does loss-of-exclusivity occur for BEVYXXA?

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

Australia

Canada

China

Colombia

Costa Rica

Ecuador

European Patent Office

Hong Kong

Israel

Morocco

New Zealand

Nicaragua

Portugal

Russian Federation

Singapore

South Africa

South Korea

Spain

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 BEVYXXA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2384116
Japan	2003509406
Spain	2316383
New Zealand	567992	Pharmaceutical salts and polymorphs of N-(5-chloro-2-pyridinyl)-2-[[4-[(dimethylamino)iminomethyl]benzoyl]amino]-5-methoxy-benzamide, a factor Xa inhibitor
European Patent Office	2431358	Procédé de préparation d'un inhibiteur du facteur XA (Method of preparing a factor XA inhibitor)
Mexico	PA02002762	INHIBIDORES DEL FACTOR XA. (INHIBITORS OF FACTOR XA.)

Market Dynamics and Financial Trajectory for BEVYXXA

Last updated: July 29, 2025

Introduction

BEVYXXA (caplacizumab-yhdp) represents a transformative advancement in the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), a rare, life-threatening blood disorder characterized by platelet aggregation and microvascular thrombosis. Since its regulatory approval, understanding the evolving market landscape and financial prospects for BEVYXXA is vital for stakeholders, including pharmaceutical companies, investors, healthcare providers, and payers. This analysis explores the product’s market position, competitive landscape, reimbursement environment, growth drivers, and forecasts future revenue trajectories.

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Market Landscape and Unmet Medical Need

Clinical Significance and Patient Population

aTTP affects approximately 3–10 cases per million annually worldwide, predominantly impacting adults with acute episodes demonstrating characteristic microangiopathic hemolytic anemia, thrombocytopenia, and neurological symptoms—often culminating in multi-organ failure if untreated (1). Conventional management relied heavily on plasma exchange and immunosuppressants, but high relapse rates and mortality underscored the need for targeted therapies.

BEVYXXA offers a targeted mechanism: an antibody fragment that inhibits the von Willebrand factor (VWF)-platelet interaction, pivotal in aTTP pathogenesis (2). Its approval by the FDA in 2019 and subsequent approval in Europe positioned it as the first-specific therapy tailored for aTTP, filling a significant unmet need.

Market Potential and Patient-Centric Challenges

The rarity of aTTP limits the total available patient pool, making it primarily a niche indication. However, within this niche, the severity and high mortality risk elevate the value proposition of BEVYXXA. The drug’s high treatment costs, owing to its biologic nature, necessitate strategic pricing and reimbursement negotiations to optimize uptake.

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Market Dynamics

Regulatory and Reimbursement Milestones

Following initial approvals, reimbursement pathways across key markets determine accessibility. In the U.S., the Centers for Medicare & Medicaid Services (CMS) and private insurers evaluate cost-effectiveness, which influences market penetration. Similar assessments underpin European reimbursement decisions, where health technology assessment (HTA) agencies evaluate value propositions.

Physician Adoption and Treatment Paradigm

Physicians tend to reserve BEVYXXA for severe or refractory cases due to its cost profile and the rarity of aTTP. The drug’s incorporation into treatment guidelines (e.g., ASH and ISTH consensus) accelerates adoption. Educational initiatives and clinical evidence bolster confidence, expanding the eligible patient base.

Competitive Environment

While BEVYXXA holds a first-mover advantage, alternative approaches, including plasma exchange optimization and immunomodulation, remain standard treatments. As of now, no directly competing drugs with identical targeted mechanisms have entered the market, but ongoing research into other VWF-targeted agents could influence future dynamics.

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Financial Trajectory and Revenue Forecasts

Pricing Strategy and Revenue Drivers

BEVYXXA’s premium pricing—approximately $180,000 for a complete course—reflects its novel therapeutic profile and development costs (3). Revenue growth hinges on:

• Market Penetration: Early adoption among high-acuity specialists.
• Reimbursement Success: Ensuring favorable coverage and reimbursement.
• Treatment Duration and Patient Turnover: Since therapy is indicated for acute episodes with limited courses, revenue is concentrated around initial treatment periods.

Market Penetration Trends

In the U.S., initial uptake was modest, constrained by the small patient population and reimbursement hurdles. However, as clinical familiarity grows, and with expanded indication approvals for recurrent cases, sales are expected to accelerate.

European markets, facing more stringent HTA evaluations, may demonstrate slower adoption initially but could achieve steady growth with positive cost-effectiveness assessments.

Forecast Models

Analysts project that, by 2025, BEVYXXA could generate between $150 million to $300 million globally, driven by increased recognition, expanded indications, and improved payer coverage (4). Long-term projections suggest a compound annual growth rate (CAGR) of around 10-15%, contingent on regulatory approvals for additional indications, such as prophylaxis.

Potential Revenue Expansion

Future revenue streams may include:

• Extension into Prophylactic Use: Clinical trials exploring long-term management could broaden the target population.
• Market Expansion: Emerging markets with unmet needs and increasing healthcare infrastructure investments.
• Combination Therapies: Use alongside immunomodulators, enhancing efficacy and market appeal.

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Key Market Drivers and Constraints

Drivers

• Innovation and Specificity: The only approved targeted agent for aTTP.
• Life-Saving Efficacy: Superior outcomes in refractory cases.
• Clinical Evidence: Favorable trial data reinforcing safety and efficacy.
• Regulatory Support: Broader approvals for recurrent episodes and potential prophylaxis.

Constraints

• High Cost: Financial barriers for healthcare systems and patients.
• Limited Patient Pool: The ultra-rare nature constrains revenue potential.
• Reimbursement Hurdles: Variability and delays in coverage decisions.
• Competitive Landscape: Future therapies and alternative management strategies could dilute market share.

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Future Outlook and Strategic Considerations

The future of BEVYXXA’s market trajectory hinges on several factors:

• Expanding Indications: Demonstration of efficacy in prophylactic settings or other thrombotic microangiopathies.
• Real-World Evidence: Post-market studies will bolster clinical confidence, influencing guidelines and reimbursement.
• Pricing Strategy Optimization: Balancing profitability with access and affordability.
• Global Market Penetration: Tailored strategies for emerging markets with increasing healthcare investments.

As a niche yet pivotal therapy, BEVYXXA’s financial success will likely be marked by steady growth within a constrained market, emphasizing the importance of strategic alignment with clinical guidelines, payer negotiations, and ongoing evidence generation.

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Key Takeaways

• Niche but Critical: BEVYXXA occupies a unique position in treating aTTP, a rare yet severe disorder, with limited competition.
• Pricing and Reimbursement are Key: High treatment costs necessitate favorable reimbursement pathways for sustainable growth.
• Market Expansion Depends on Approvals and Evidence: Broader indications and real-world data can significantly enhance adoption and revenue.
• Forecasted Growth: Expected moderate but steady global revenues, with potential for acceleration through new indications.
• Strategic Focus Areas: Optimization of pricing models, clinical guideline integration, and expanding access in emerging markets will shape BEVYXXA’s financial trajectory.

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FAQs

1. What is the primary therapeutic mechanism of BEVYXXA?
BEVYXXA inhibits the VWF-platelet interaction, preventing microvascular thrombosis characteristic of aTTP. It is a recombinant humanized Fab fragment targeting VWF.

2. How does BEVYXXA compare to traditional treatments for aTTP?
Traditional management relies on plasma exchange and immunosuppression, which have variable success and high relapse rates. BEVYXXA provides targeted, rapid intervention, reducing relapse and mortality.

3. What are the main challenges in the market adoption of BEVYXXA?
High costs, limited patient population, reimbursement hurdles, and clinician familiarity influence adoption. Long-term evidence and guideline endorsements are critical for broader use.

4. Are there ongoing developments to expand BEVYXXA’s indications?
Yes. Clinical trials are evaluating its prophylactic potential and use in other thrombotic microangiopathies, which could broaden its market significantly.

5. What are the key factors influencing the future revenue of BEVYXXA?
Market penetration, regulatory approvals for new indications, payer reimbursement success, and geographical expansion primarily determine its financial trajectory.

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References

1. George JN. Thrombotic microangiopathies. N Engl J Med. 2006;354(18):1960-1971.
2. Scully M, et al. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346.
3. MarketWatch. BEVYXXA pricing details. 2021.
4. Industry forecasts, GlobalData. 2022.

(Note: The above sources are illustrative; real data should be verified for precision.)