BETRIXABAN - Generic Drug Details

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

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 Applications:	845
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			Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No			Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	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	208383-001	Jun 23, 2017		DISCN	Yes	No

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	208383-001	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

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/004309 Prevention of venous thromboembolism	Refused	no	no	no		2018-09-20

International Patents for BETRIXABAN

Country	Patent Number	Title	Estimated Expiration
Portugal	2101760
Ecuador	SP099501	FORMULACIONES DE DOSIS UNITARIA Y MÉTODOS PARA EL TRATAMIENTO DE LA TROMBOSIS CON UN INHIBIDOR ORAL DEL FACTOR XA
Japan	5766204
Hong Kong	1134031	UNIT DOSE FORMULATIONS AND METHODS OF TREATING THROMBOSIS WITH AN ORAL FACTOR XA INHIBITOR
South Korea	101358574
European Patent Office	2513058	PROCÉDÉS DE SYNTHÈSE D'INHIBITEURS DU FACTEUR XA (METHODS OF SYNTHESIZING FACTOR XA INHIBITORS)

BETRIXABAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Betrixaban

Introduction to Betrixaban

Betrixaban, marketed as Bevyxxa, is a novel oral anticoagulant approved by the FDA in June 2017 for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE[3].

Market Need and Unmet Demand

The market for VTE prophylaxis is substantial, driven by the high incidence of VTE among hospitalized patients. VTE is a leading cause of preventable hospital deaths, and the economic burden associated with it is significant, with average annual direct medical costs in the U.S. ranging from $7,500 to $16,500 per patient[3].

Competitive Landscape

Betrixaban competes primarily with enoxaparin, which is marketed as Lovenox, and other anticoagulants like dabigatran, edoxaban, and rivaroxaban. However, betrixaban's unique selling point is its extended-duration prophylaxis (35 to 42 days) without an increase in major bleeding, setting it apart from standard VTE prophylaxis regimens[3].

Clinical Efficacy and Safety

The pivotal Phase 3 APEX study demonstrated that betrixaban significantly reduced the risk of VTE and VTE-related events without increasing major bleeding. It also showed a reduction in fatal or irreversible events and VTE-related rehospitalizations compared to enoxaparin[2][3].

Economic and Cost-Effectiveness

Betrixaban has been shown to be cost-effective in several analyses. For instance, extended VTE prophylaxis with betrixaban could save hospitals approximately $447,000 annually, or $182 per patient, by reducing VTE events and related hospitalizations[2]. Another analysis estimated that betrixaban could save nearly $1.8 million, or $178 per patient treated, compared to enoxaparin, while also increasing quality-adjusted life-years (QALYs)[2].

Market Size and Growth

The global anticoagulant market, which includes betrixaban, is expected to grow significantly. While specific market size figures for betrixaban alone are not provided, the overall anticoagulant market is projected to see substantial growth driven by increasing demand for effective VTE prophylaxis[1].

Regional Market Analysis

Betrixaban's market performance varies by region. In North America, Europe, South America, and the APAC region, the drug is expected to gain traction due to its unique benefits and the high incidence of VTE. For example, in the U.S., the market revenue for anticoagulants, including betrixaban, is projected to increase significantly from 2023 to 2030[1].

Key Players and Supply Chain

Portola Pharmaceuticals, now part of Alexion Pharmaceuticals, holds worldwide rights for the development and commercialization of betrixaban. The API market for betrixaban involves several key players, including Hovione, Viatris, LGM Pharma, and others, who supply the active pharmaceutical ingredient necessary for the production of Bevyxxa[4].

Financial Trajectory

The financial trajectory for betrixaban is promising due to its clinical efficacy, cost-effectiveness, and market demand. Here are some key financial highlights:

• Revenue Potential: The launch of Bevyxxa in the U.S. in January 2018 marked the beginning of its commercial journey. With a targeted sales and marketing strategy focused on hospitals, Portola aimed to capture a significant share of the multi-billion dollar VTE prophylaxis market[3].
• Cost Savings: Betrixaban is expected to save hospitals significant costs by reducing VTE events and related hospitalizations. For instance, a cost-effectiveness model estimated that betrixaban could save nearly $1.8 million annually for a cohort of 10,000 patients[2].
• Formulary Placement: Stakeholders agree that betrixaban's formulary placement will not be problematic if used as studied and approved, given its economic and clinical benefits[2].

Challenges and Opportunities

While betrixaban has several advantages, there are challenges to its adoption:

• Awareness: One of the primary barriers is awareness among prescribers. Increasing education and engagement with medical professionals is crucial for wider adoption[2].
• Payer Barriers: Although stakeholders believe that payer barriers will be minimal, ensuring that payers recognize the long-term cost benefits of betrixaban is essential[2].

Future Outlook

The future outlook for betrixaban is positive, driven by its unique clinical profile and economic benefits. As more hospitals and healthcare systems adopt extended-duration VTE prophylaxis, betrixaban is poised to become a leading anticoagulant in this space.

Key Takeaways

• Clinical Efficacy: Betrixaban significantly reduces VTE and VTE-related events without increasing major bleeding.
• Cost-Effectiveness: Extended VTE prophylaxis with betrixaban is cost-effective, saving hospitals significant costs.
• Market Potential: The global anticoagulant market, including betrixaban, is expected to grow substantially.
• Regional Growth: Betrixaban is expected to perform well in various regions, including North America, Europe, and the APAC region.
• Financial Trajectory: The drug has a promising financial trajectory due to its revenue potential and cost savings.

FAQs

Q: What is betrixaban used for? A: Betrixaban is used for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications.

Q: How does betrixaban compare to enoxaparin? A: Betrixaban has been shown to reduce fatal or irreversible events and VTE-related rehospitalizations more effectively than enoxaparin without increasing major bleeding.

Q: What are the economic benefits of using betrixaban? A: Betrixaban can save hospitals significant costs by reducing VTE events and related hospitalizations, estimated to be around $447,000 annually.

Q: Who are the key players in the betrixaban API market? A: Key players include Hovione, Viatris, LGM Pharma, and others.

Q: What is the current market status of betrixaban? A: Betrixaban was launched in the U.S. in January 2018 and is being commercially promoted by Portola Pharmaceuticals, now part of Alexion Pharmaceuticals.

Cited Sources

1. IndustryARC: AntiCoagulants Market Share, Size and Industry Growth Analysis 2019.
2. AJMC: The Use of Betrixaban for Extended Prophylaxis of Venous Thromboembolism Events in Hospitalized High-Risk Patients.
3. Annual Reports: Portola Pharmaceuticals Annual Report 2017.
4. Valuates Reports: Global Betrixaban API Market, Report Size, Worth, Revenue, Growth.