BEVYXXA Drug Patent Profile

When do Bevyxxa patents expire, and when can generic versions of Bevyxxa launch?

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.

Indicators of Generic Entry

Summary for BEVYXXA

International Patents:	67
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	84
Patent Applications:	420
Drug Prices:	Drug price information 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
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No			Y

Expired US Patents for BEVYXXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	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
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/004309 Prevention 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
Russian Federation	2002110295
South Africa	200202117	Inhibitors of factor Xa.
Mexico	226123	BENZAMIDAS E INHIBIDORES DEL FACTOR XA RELACIONADAS. (BENZAMIDES AND RELATED INHIBITORS OF FACTOR Xa.)
Norway	20021229
World Intellectual Property Organization (WIPO)	0164642
Israel	199219	בטריקסאבאן או מלחיו, לשימוש בעיכוב קרישת דם (Betrixaban or salt thereof for use in inhibiting blood coagulation)
South Africa	200803820	Pharmaceutical salts and polymorphs of N-(5-chloro-2-pyridinyl)-2-[[4-[(dimethylamino) iminomethyl] benzoyl] amino]-5-meth oxy-benzamide, A factor Xa inhibitor

BEVYXXA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bevyxxa

Introduction to Bevyxxa

Bevyxxa, also known as betrixaban, is a novel oral anticoagulant (NOAC) developed by Portola Pharmaceuticals. It is specifically designed for the prophylaxis of venous thromboembolism (VTE) in acute medically ill patients, a population with a high unmet need for effective anticoagulant therapy.

FDA Approval and Market Entry

In December 2017, the FDA approved Portola's Prior Approval Supplement (PAS) for Bevyxxa, allowing for its commercial launch in early January 2018. This approval marked a significant milestone, as Bevyxxa became the first anticoagulant therapy approved for VTE prophylaxis in acute medically ill patients, a large and underserved patient population[1].

Market Positioning

Bevyxxa entered a competitive market dominated by established NOACs such as Xarelto (rivaroxaban) from J&J/Bayer, Pradaxa (dabigatran) from Boehringer Ingelheim, Eliquis (apixaban) from BMS, and Savaysa (edoxaban) from Daiichi Sankyo. However, Bevyxxa's unique approval for VTE prophylaxis in acute medically ill patients positioned it to capture a significant share of this lucrative market[1].

Competitive Advantage: Reversal Agent

A key factor enhancing Bevyxxa's market prospects was the upcoming launch of andexanet alfa, a Factor Xa reversal agent developed by Portola Pharmaceuticals. The lack of a reversal agent had been a significant concern for physicians and patients using NOACs, as it posed a risk in cases of traumatic bleeding. The availability of andexanet alfa provided an additional layer of safety and security, making Bevyxxa more attractive compared to other NOACs without approved reversal agents[1].

Financial Performance: Initial Years

In the initial years following its launch, Bevyxxa generated modest revenues. For the fourth quarter of 2018, Bevyxxa sales contributed only $35,000 to Portola's total revenues, which were largely driven by sales of Andexxa ($14 million) and collaboration and license revenues ($1.2 million)[2].

Revenue Growth and Challenges

Despite its promising market position, Bevyxxa's commercial performance did not meet expectations. By 2019, Portola Pharmaceuticals decided to discontinue the commercialization of Bevyxxa, citing a $27.5 million charge for Bevyxxa inventory and manufacturing in the fourth quarter of 2019. This decision reflected the challenges Bevyxxa faced in gaining significant market traction against established competitors[5].

Impact on Portola Pharmaceuticals' Financials

The discontinuation of Bevyxxa had a notable impact on Portola Pharmaceuticals' financials. The company reported a net loss of $290.7 million for the full year 2019, which included the charges related to Bevyxxa's discontinuation. Despite this, the company's total revenues increased to $116.6 million in 2019, primarily driven by the success of Andexxa/Ondexxya sales[5].

Market Trends and Future Outlook

The global antithrombotic drugs market, including NOACs like Bevyxxa, is expected to grow steadily, reaching $38.5 billion by 2031 with a CAGR of 4.1%. This growth is driven by factors such as the increasing incidence of cardiovascular diseases, the need for safe and effective anticoagulants, and the availability of antidotes. However, premium pricing and generic erosion are expected to slow market growth[4].

Key Takeaways

• Unique Approval: Bevyxxa was the first anticoagulant approved for VTE prophylaxis in acute medically ill patients.
• Competitive Market: Bevyxxa entered a market dominated by established NOACs but had a unique selling point with its approval and the availability of a reversal agent.
• Financial Performance: Despite initial promise, Bevyxxa's commercial performance was disappointing, leading to its discontinuation.
• Impact on Portola: The discontinuation affected Portola's financials, but the company's overall revenues increased due to Andexxa/Ondexxya sales.
• Market Outlook: The antithrombotic drugs market is expected to grow, but at a slower rate due to premium pricing and generic erosion.

FAQs

What is Bevyxxa used for?

Bevyxxa (betrixaban) is used for the prophylaxis of venous thromboembolism (VTE) in acute medically ill patients.

Why was Bevyxxa significant in the market?

Bevyxxa was significant because it was the first anticoagulant therapy approved for VTE prophylaxis in acute medically ill patients, addressing a high unmet need.

What was the impact of andexanet alfa on Bevyxxa's market prospects?

The availability of andexanet alfa, a Factor Xa reversal agent, provided an additional layer of safety and security, enhancing Bevyxxa's market prospects.

Why was Bevyxxa's commercialization discontinued?

Bevyxxa's commercialization was discontinued due to its failure to gain significant market traction against established competitors.

How did the discontinuation of Bevyxxa affect Portola Pharmaceuticals' financials?

The discontinuation resulted in a significant charge and contributed to the company's net loss, but overall revenues increased due to the success of Andexxa/Ondexxya sales.

Sources

1. Clinical Trials Arena: "Portola's Bevyxxa Will Soon Secure a Critical Market Position in the VTE Space"
2. GlobeNewswire: "Portola Pharmaceuticals Reports Fourth Quarter and Full-Year 2018 Financial Results and Provides Corporate Update"
3. iHealthcareAnalyst: "Global Antithrombotic Drugs Market $38.5 Billion by 2031"
4. BioSpace: "Portola Pharmaceuticals Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Corporate Update"