Betrixaban - Generic Drug Details

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

Betrixaban is the generic ingredient in one branded drug marketed by Portola Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for betrixaban

International Patents:	67
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for betrixaban
DailyMed Link:	betrixaban at DailyMed

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

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 betrixaban

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

Sponsor	Phase
Portola Pharmaceuticals	Phase 3
Merck Sharp & Dohme Corp.	Phase 2
Portola Pharmaceuticals	Phase 1

See all betrixaban clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for betrixaban

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for betrixaban

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	208383-002	Jun 23, 2017		DISCN	Yes	No			Y
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	208383-001	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			Y

Expired US Patents for betrixaban

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	208383-002	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 betrixaban

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 betrixaban

Country	Patent Number	Title	Estimated Expiration
Colombia	6220933	FORMULACIONES DE DOSIS UNITARIA Y METDODS PARA EL TRATAMIENTO DE LA TROMBOSIS CON UN INHIBIDOR ORAL DEL FACROR XA
Japan	2012246323	PHARMACEUTICAL SALT AND POLYMORPH OF N- (5-CHLORO-2-PYRIDINYL)-2-[[4-[(DIMETHYLAMINO)IMINOMETHYL]BENZOYL]AMINO]-5-METHOXY-BENZAMIDE, FACTOR XA INHIBITOR
Portugal	2101760
Canada	2784904
European Patent Office	2101760	FORMULATIONS DE DOSES UNITAIRES ET PROCÉDÉS DE TRAITEMENT D'UNE THROMBOSE AVEC UN INHIBITEUR ORAL DU FACTEUR XA (UNIT DOSE FORMULATIONS AND METHODS OF TREATING THROMBOSIS WITH AN ORAL FACTOR XA INHIBITOR)
Spain	2384116
Canada	2671502

Betrixaban Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for BETRIXABAN?

Betrixaban, an oral anticoagulant, competes in the global market primarily dominated by direct oral anticoagulants (DOACs). Its market landscape is influenced by patent status, regulatory approvals, clinical efficacy, safety profile, and competition from established drugs like rivaroxaban, apixaban, and dabigatran.

Key market drivers:

• Clinical preference for DOACs: Increasing adoption due to ease of use over warfarin and in combination with existing therapies.
• Regulatory approvals: Approved in multiple markets, including the United States (FDA, 2018), the European Union (EMA, 2017), for indications such as atrial fibrillation and venous thromboembolism.
• Patent exclusivity and biosimilar entry: Patent expiration timelines impact market share; currently under patent protection in major markets until approximately 2030.
• Chronic use and rising cardiovascular disease prevalence: Contribute to steady demand growth.

Market challenges:

• Competition: Rivaroxaban and apixaban hold leading market share.
• Side effect profile: Bleeding risk remains a concern, influencing prescribing behaviors.
• Cost and reimbursement policies: Influence prescribing and patient access in different regions.

Market figures & trends:

• The global anticoagulant market was valued at over USD 18 billion in 2022.
• Expected compounded annual growth rate (CAGR) from 2023 to 2030: approximately 6.5% (Grand View Research).
• Betrixaban’s market penetration remains limited relative to rivaroxaban and apixaban, which together account for over 70% of DOAC sales in the United States.

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What Is the Financial Trajectory for Betrixaban?

Analyzing Betrixaban's financial prospects involves examining sales projections, R&D investments, pricing strategies, and potential market share.

Revenue Projections

• Based on current market share estimations (roughly 5-8% of the DOAC segment in key markets), Betrixaban's sales could reach USD 250–400 million annually within five years.
• The growth depends on approval extensions, label expansions, and competitive positioning.

R&D and Regulatory Expenses

• Development costs for new indications or formulations estimated at USD 300–500 million, including clinical trials, regulatory filings, and post-marketing surveillance.
• Once launched, ongoing costs involve manufacturing, marketing, and compliance.

Pricing & Reimbursement

• Pricing varies regionally: approximately USD 300–500 per month in the United States.
• Reimbursement policies influence net revenue; lack of formulary inclusion could limit sales.

Market Entry & Competition Impact

• Patent expiry of leading rivals (rivaroxaban in 2024, apixaban scheduled for 2025 in some markets) free up market share that Betrixaban could capture, assuming favorable pricing and safety profiles.
• Strategic alliances or licensing deals could enhance market penetration.

Investment Estimate & Return

• An initial marketing investment of approximately USD 50–100 million could establish presence in key markets.
• Break-even expected within 4–6 years post-launch, contingent on sales volume and competitive responses.

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How Do Regulatory and Policy Factors Influence Betrixaban’s Market and Financial Outlook?

• Regulatory approvals: Critical for commercial viability; delays can stall revenue.
• Patent landscape: Patent expiry timelines influence potential generic entry post-2030, impacting long-term revenues.
• Reimbursement policies: High-cost drugs depend on favorable reimbursement to sustain sales.
• Off-label use restrictions: Limitations on indications could restrict market expansion.

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Key Takeaways

• The global anticoagulant market remains highly competitive, with Betrixaban facing pressure from premium market leaders.
• Patent protections last until approximately 2030 in major regions; after expiry, biosimilar entry will challenge pricing and market share.
• Revenue forecasts suggest modest growth, contingent on regulatory success and competitive strategy.
• Cost structure involves significant R&D investments and marketing expenses; breakeven is projected 4–6 years after market launch.
• Policy environment, patent protections, and clinical safety profiles significantly influence market dynamics and financial performance.

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What Are Five FAQs About Betrixaban?

1. When will Betrixaban likely face generic competition?
Patent protection in major markets lasts until roughly 2030, after which biosimilar competitors could enter, putting pressure on pricing and market share.

2. How does Betrixaban compare to its competitors?
It has a similar safety and efficacy profile but lacks the market share dominance of rivaroxaban and apixaban, which have established extensive clinical use and commercialization networks.

3. What are the main regulatory hurdles for Betrixaban?
Obtaining approvals for additional indications and ensuring post-marketing safety monitoring are primary challenges that impact market expansion.

4. How do reimbursement policies affect Betrixaban?
Reimbursement rates and formulary inclusion critically influence uptake, especially in markets with strict cost control measures.

5. What factors could significantly alter Betrixaban's financial outlook?
Emergence of new competing drugs, unexpected safety concerns, or major shifts in reimbursement policy could alter projections.

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References

1. Grand View Research, "Anticoagulant Market Size, Share & Trends Analysis Report," 2023.
2. U.S. Food and Drug Administration, "Betrixaban approval notice," 2018.
3. European Medicines Agency, "Betrixaban marketing authorization," 2017.
4. IQVIA, "Global Pharmaceutical Market Data," 2022.
5. Patentscope, “Patent expiration dates for rivaroxaban and apixaban,” 2023.