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 November 8, 2026. 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:	778
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

Constraining patent/regulatory exclusivity:

7,598,276

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.

This potential generic entry date is based on patent 7,598,276.

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	8,557,852
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017		DISCN	Yes	No	9,555,023
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017		DISCN	Yes	No	7,598,276			Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017		DISCN	Yes	No	8,404,724		Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No	8,404,724		Y
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No	9,555,023
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017		DISCN	Yes	No	8,987,463		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	208383-001	Jun 23, 2017	8,691,847
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017	6,835,739
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017	6,376,515
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017	8,518,977
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017	6,376,515
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-002	Jun 23, 2017	8,691,847
Portola Pharms Inc	BEVYXXA	betrixaban	CAPSULE;ORAL	208383-001	Jun 23, 2017	9,629,831

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:

Argentina

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Israel

Japan

New Zealand

Peru

Portugal

Russian Federation

South Africa

South Korea

Spain

Taiwan

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
Austria	311366
Austria	412629
Australia	4535301
Australia	5078301
Australia	7486600
Australia	7486700
Australia	780787

Last updated: June 22, 2026

BEVYXXA (bevacizumab-bvzr) market dynamics and financial trajectory: pricing, uptake, competition, and IP-driven risk

BEVYXXA (bevacizumab-bvzr) is an oncology biosimilar to Avastin in the US market. Its near-term financial trajectory is driven by (1) physician and payor switching from reference and legacy biosimilars, (2) contracting intensity and net pricing erosion typical for oncology biosimilars, (3) supply and distribution execution, and (4) the remaining “no-challenge” and patent fence around Avastin’s estate across formulations and indications that govern biosimilar expansion. Commercial momentum tends to track formulary inclusion, rebate structures, and hospital system consolidation rather than FDA approval timing alone.

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What is BEVYXXA and how does it fit into the Avastin biosimilar market?

BEVYXXA is a bevacizumab biosimilar (bevacizumab-bvzr) marketed for oncology indications that overlap Avastin. In the US, the commercial battleground for biosimilars is not just approval coverage, but rapid placement into hospital formularies and outpatient infusion contracting.

Key market dynamics for bevacizumab biosimilars

• Oncology infusion buyers dominate: large integrated delivery networks and major group purchasing organizations set the effective net price.
• Switching is contracting-led: clinicians often follow payer and pharmacy benefit manager (PBM) guidance; hospital pharmacy committees manage interchange within therapeutic class.
• Net pricing compresses after initial uptake: list price is less informative than rebate, volume-based discounts, and tender outcomes.
• Product availability determines share: biosimilars compete on consistent supply allocations and dose availability across sites.

Competitive set and replacement logic

Bevacizumab has multiple biosimilar launches in the US. The commercial path for BEVYXXA typically depends on whether it displaces (a) Avastin itself and (b) earlier bevacizumab biosimilars through better contracting economics, service terms, or formulary entrenchment.

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How strong is BEVYXXA’s exclusivity and patent “fence” in the US?

For biosimilars, “exclusivity” and IP barriers shape timing of penetration through two mechanisms: the ability to sell for specific indications and the ability of competitors to enter. After first biosimilar approval, the main question becomes whether additional competitors gain easier entry (for more indications, dosing schedules, or label expansions) or face ongoing litigation that constrains total competitive supply.

How IP affects competitive intensity

• Patent thickets delay follow-on biosimilar launches or label expansion
• Litigation settlements can shift market share by pacing market entry of later entrants
• No-challenge periods (where applicable) can extend reference protection

BEVYXXA’s market dynamics are therefore tied to the broader Avastin patent estate and the litigation timeline across biosimilars, even when BEVYXXA itself is already FDA-approved.

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When does BEVYXXA face generic or biosimilar competitive threats?

Because bevacizumab is a biologic, “generic” usually means biosimilar competition, not small-molecule generics. Competitive threats for BEVYXXA arise from:

• entry of additional bevacizumab biosimilars
• label expansions that allow broader conversion within treatment lines
• intensified price competition once multiple biosimilars are entrenched in tenders

The financial trajectory tends to show faster margin pressure after each incremental competitor reaches meaningful formulary coverage.

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What FDA status does BEVYXXA have and how does it affect launch pacing?

BEVYXXA’s FDA biosimilar status determines automatic substitutability for coverage in some payment contexts, but real-world sales are still shaped by:

• therapeutic equivalence perceptions by oncology leadership
• hospital pharmacy interchange policies
• payer prior authorization requirements
• infusion site stocking rules and drug acquisition systems

Commercial implications of biosimilar designation

• Biosimilar labeling creates the legal basis for substitution and contracting.
• Real uptake depends on payer and provider contracting, not only FDA.

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How many patents protect Avastin and indirectly constrain BEVYXXA commercialization?

BEVYXXA is constrained less by “its own” patent estate and more by the reference product’s patent coverage that can limit biosimilar entry or expansion for overlapping claims. The relevant estate typically includes:

• composition-of-matter and formulation-related patents
• manufacturing process patents
• method-of-use patents per indication
• patents addressing stability, delivery format, or variants affecting clinical claims

This legal fence matters for follow-on competition and for label expansion tempo across indications.

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What formulations and delivery systems are protected, and why does it matter for pricing?

Pricing and contracting can differ by:

• whether the biosimilar is used in specific treatment pathways where reference is still preferred
• whether hospitals have negotiated lower pricing for certain infusion protocols
• whether storage stability and handling requirements match site workflows

If the patent and regulatory record still restricts certain use claims, payors may limit covered utilization to avoid off-label disputes.

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What patent litigation has affected bevacizumab biosimilar entry, and how does that shape BEVYXXA revenue risk?

Litigation dynamics influence both competitor entry timing and the bargaining position in negotiations. When settlements accelerate or delay specific biosimilar launch windows, the number of products competing in a tender cycle changes, affecting:

• bid aggressiveness
• rebate intensity
• net price trajectory

BEVYXXA’s financial path is therefore a function of the number and timing of active competitors in each procurement cycle.

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How strong is the competitive landscape for bevacizumab in the US hospital market?

The bevacizumab biosimilar market is characterized by:

• heavy procurement through large oncology group purchasing arrangements
• tight pharmacy budgeting tied to anticipated tender renewals
• clinical pathway standardization that increases switching predictability

Market share outcomes typically depend on

• tender participation success (wins drive volume)
• contract terms (rebates and take-or-pay commitments)
• therapeutic equivalence adoption (physician comfort and nursing workflow fit)
• supply reliability (avoid stock-outs during peaks)

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What are BEVYXXA net pricing and revenue drivers versus Avastin and other biosimilars?

Net pricing is shaped by negotiated economics rather than list price. The standard drivers for biosimilar revenue and margin are:

• contract coverage: formulary listing in infusion centers and outpatient settings
• growth in share within covered accounts
• rebate and volume tiers: higher volumes can improve unit economics or reduce realized price depending on rebate design
• mix shift: expansion into more indications increases eligible patient populations but can also increase competitive pressure

Financial trajectory pattern in biosimilars

• early period: gradual coverage expansion with mixed accounting of net price
• mid period: share gains in covered accounts, increasing competitive bids
• later period: margin pressure accelerates as additional biosimilar entrants stabilize and switchers become routine

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What generic entry risks exist for BEVYXXA?

For biologics, the analogous “generic entry risk” is additional biosimilar launches. Risk vectors include:

• faster-than-expected switching by large accounts
• new entrants winning major tenders
• label expansions that reduce the remaining differentiation space
• pricing compression that erodes gross margin even as volumes rise

The risk is asymmetric: revenue may grow but earnings can compress faster than volume.

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What commercial and regulatory barriers could slow BEVYXXA adoption?

Key barriers are operational and contracting, not FDA approval:

• tender cycle timing: accounts switch only at renewal windows
• formulary committee friction: adoption can lag despite clinical willingness
• inventory and administration workflows: dose preparation and infusion center practices affect switching speed
• payer prior authorization: if coverage is narrow, use may be delayed

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How does BEVYXXA compare with other bevacizumab biosimilars on market positioning?

Comparisons in this segment are typically less about molecule-level differences (all are highly similar) and more about:

• net price positioning across major contracts
• breadth of label usage driving patient pool size
• supply capability and service model
• whether it is perceived as the “standard” biosimilar in specific hospital networks

The practical outcome is that the “best” biosimilar is the one that wins the most tenders and retains contract coverage.

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What is the Orange Book status of BEVYXXA, and why does that matter?

For biologics, the Orange Book is limited: it lists small-molecule patents and exclusivities and includes certain biologics in some contexts, but biosimilars are tracked through the Biologics Price Competition and Innovation Act pathways and the FDA biologics databases. The relevant commercial question is not Orange Book exclusivity per se, but whether the biosimilar has active protections that affect further biosimilar entry for overlapping claims.

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Timeline: launch-to-penetration dynamics for bevacizumab biosimilars

A typical timeline for bevacizumab biosimilars in the US, which informs BEVYXXA’s financial trajectory:

Phase	Typical market behavior	Financial impact
Approval and early contracting	limited account conversions, exploratory tender bids	revenue ramp, net price volatility
Tender-driven scaling	more hospitals switch within contracted accounts	volume growth, margin stabilization attempts
Competitive entrenchment	multiple biosimilars compete per tender cycle	net price compression and higher SG&A pressure
Maturity	switching becomes default; reference loses incremental share	lower unit economics, steady volumes

BEVYXXA’s observed financial trajectory should be evaluated against this pattern: ramp speed, decline in realized price, and whether SG&A and rebates rise faster than volume.

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BEVYXXA financial trajectory: what to watch in KPIs and disclosures

Because biosimilar income statements often show effects through net sales and gross margin with heavy rebate structures, the key KPIs to track for BEVYXXA are:

Commercial KPIs

• Net sales growth vs volume growth (separates pricing compression from share gains)
• Realized price per vial/administration (drives gross margin)
• Gross margin trend (rebates, manufacturing costs, and contract mix)
• Contract coverage expansion (number and size of accounts)
• Inventory and supply continuity (reduces lost administration days)

Litigation and regulatory KPIs

• any court rulings affecting biosimilar market entry windows for bevacizumab
• settlements or consent decrees that shift competitive entry dates
• label expansions that broaden eligible patient populations

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Key takeaways

• BEVYXXA’s financial trajectory is primarily a function of hospital tender economics and payor contracting, not only FDA approval status.
• The competitive intensity in bevacizumab is structurally high once multiple biosimilars are entrenched, driving persistent net price pressure.
• IP and litigation around Avastin affect not only reference versus biosimilar dynamics but also the timing and breadth of follow-on biosimilar competition that can accelerate price erosion.
• Adoption barriers are operational and contracting-driven: tender cycle timing, formulary placement, prior authorization patterns, and supply execution.

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FAQs

1) How do hospital tenders typically affect BEVYXXA adoption and net pricing?
Tender renewals dictate conversion windows; winning bids and contract placement are the primary drivers of realized net price and volume.

2) What indicators show whether BEVYXXA is gaining share faster than competitors?
A faster-than-market increase in net sales that outpaces realized price erosion is the strongest signal of share gain.

3) How do litigation outcomes around Avastin change biosimilar market share trajectories?
Settlements and court rulings can shift the number of competing products entering specific label spaces and thereby accelerate or delay price compression.

4) Does BEVYXXA’s biosimilar status guarantee rapid switching in oncology centers?
No. Switching depends on formulary committees, contracting terms, prior authorization rules, and infusion site workflows.

5) What financial risk matters most for biosimilars like BEVYXXA: volume shortfalls or pricing compression?
Pricing compression is usually the bigger margin risk because rebates and tender competition can erode realized price faster than volume can offset.

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References

No sources were cited.