ELIQUIS Drug Patent Profile

Which patents cover Eliquis, and when can generic versions of Eliquis launch?

Eliquis is a drug marketed by Bristol Myers Squibb and Bristol and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-five patent family members in forty-two countries.

The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the apixaban profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eliquis

A generic version of ELIQUIS was approved as apixaban by ACCORD HLTHCARE on July 28^th, 2020.

Summary for ELIQUIS

International Patents:	175
US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	77
Patent Applications:	3,968
Drug Prices:	Drug price information for ELIQUIS
Drug Sales Revenues:	Drug sales revenues for ELIQUIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIQUIS
What excipients (inactive ingredients) are in ELIQUIS?	ELIQUIS excipients list
DailyMed Link:	ELIQUIS at DailyMed

See drug prices for ELIQUIS

See drug sales revenues for ELIQUIS

Recent Clinical Trials for ELIQUIS

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

Sponsor	Phase
University of Vermont	PHASE3
U.S. Food and Drug Administration (FDA)	PHASE4
VA Office of Research and Development	PHASE4

See all ELIQUIS clinical trials

Pharmacology for ELIQUIS

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Paragraph IV (Patent) Challenges for ELIQUIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELIQUIS	Tablets	apixaban	2.5 mg and 5 mg	202155	25	2016-12-28

US Patents and Regulatory Information for ELIQUIS

ELIQUIS is protected by two US patents and three FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155-003	Apr 17, 2025		RX	Yes	Yes	6,967,208*PED				Y
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155-003	Apr 17, 2025		RX	Yes	Yes
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	AB	RX	Yes	Yes
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No

Expired US Patents for ELIQUIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	6,413,980
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	6,413,980

EU/EMA Drug Approvals for ELIQUIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb / Pfizer EEIG	Eliquis	apixaban	EMEA/H/C/002148For Eliquis 2.5 mg film-coated tablets:Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).For Eliquis 5 mg film-coated tablets:Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).	Authorised	no	no	no	2011-05-18
Accord Healthcare S.L.U.	Apixaban Accord	apixaban	EMEA/H/C/005358Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).	Authorised	yes	no	no	2020-07-23

International Patents for ELIQUIS

See the table below for patents covering ELIQUIS around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	024242	COMPUESTO HETEROBICICLO CON CONTENIDO DE NITROGENO, COMPOSICION FARMACEUTICA QUE LO COMPRENDE , Y EL USO DE DICHOS COMPUESTOS EN LA FABRICACIoN DE UN MEDICAMENTO.
Austria	280171
Australia	2371700
Australia	759711
Brazil	9917080

Supplementary Protection Certificates for ELIQUIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	C300500	Netherlands		PRODUCT NAME: APIXABAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	C20110017 00045	Estonia		PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
1427415	CA 2011 00028	Denmark
1427415	91888	Luxembourg		91888, EXPIRES: 20260518
1427415	1190029-7	Sweden		PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518

Last updated: June 21, 2026

ELIQUIS (apixaban) market dynamics and financial trajectory: exclusivity, competition, pricing, and revenue outlook

Executive summary: ELIQUIS (apixaban) has remained a top US oral anticoagulant by prescription demand and payer coverage, with revenue driven by (1) broad labeling in atrial fibrillation (AF), (2) sustained uptake in venous thromboembolism (VTE) treatment and prevention, and (3) continued market-share defense versus rivaroxaban (Xarelto) and off-label and formulary alternatives. Patent and exclusivity timelines center on US composition and use protections (and Orange Book-listed exclusivities), with US generic entry risk primarily via Paragraph IV ANDAs. Commercially, the trajectory is shaped by annual script growth in high-volume indications, pricing pressure from PBM contracting after generic erosion risk increases, and share shifts tied to real-world tolerability and dosing adherence.

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How is ELIQUIS priced and reimbursed in the US (and what drives net revenue)?

Quick answer: ELIQUIS net revenue reflects list-price anchored topline offset by discounting driven by PBM rebates, plan formularies, and contracting. Net price pressure typically accelerates when formulary positioning weakens, when competitors outbid on rebates, or as generic entry risk becomes legible across large payers.

What payer and formulary dynamics shape ELIQUIS net revenue?

• Formulary tier placement: ELIQUIS is typically targeted for preferred placement under anticoagulant class management, but utilization management can shift between DOACs based on PBM contract economics and health-system formularies.
• PBM rebates and performance terms: Net revenue is heavily dependent on rebate structures and audit-proofing terms that differ by channel (commercial vs government managed care).
• White-bag and hospital procurement effects: In hospital/IDN settings, anticoagulant selection can be driven by group purchasing and perioperative protocols, which can move scripts between DOACs.
• Patient mix across indications: Higher-acuity VTE and AF subsets can carry different persistence and dose intensities, affecting net revenue per 30 days.

What commercial KPIs usually correlate with ELIQUIS financial trajectory?

• Prescription volume (scripts) by channel and indication (AF vs VTE).
• Persistence and dose adherence (DOAC adherence affects refill frequency and realized sales).
• Segment net price after rebates (net vs gross).
• Trend in competitor share (Xarelto, and local generic DOACs depending on geography and channel).

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What market dynamics drive ELIQUIS share versus Xarelto and other anticoagulants?

Quick answer: Share is most sensitive to payer formularies, switching behavior among DOACs, and clinical trust in dosing simplicity. Competitive pressure is concentrated in AF and VTE, where prescriber choice is constrained by coverage and protocol.

Where are the competitive pressure points?

• AF anticoagulation: Continuous demand supports ELIQUIS, but competitive switching can occur during formulary renewals.
• VTE treatment and prevention: Early treatment volume is sensitive to time-to-therapy and hospital standardization.
• Bleeding-risk perception and real-world outcomes: Prescriber confidence influenced by adverse event reporting can shift shares at the margin, particularly in high-risk populations.

How do competitors influence switching behavior?

• Xarelto (rivaroxaban): Strong positioning through dosing convenience and broad prescribing familiarity; payers often negotiate class-wide.
• Local generics and biosimilar-like dynamics are not the DOAC model, but price erosion still occurs through contract changes and selective generic substitution when available.
• Heparin/warfarin still matter at the margin in patients with contraindications, cost constraints, or transitions in care.

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When do key ELIQUIS exclusivity protections end in the US?

Quick answer: ELIQUIS faces an exclusivity and patent landscape typical for a small-molecule branded drug: a mix of regulatory exclusivities (including new chemical entity and related exclusivity where applicable) and later-expiring composition, formulation, and method-of-use patents listed in the Orange Book. Generic entry risk increases when the earliest expiring patent or exclusivity is surpassed and when Paragraph IV litigation cycles conclude.

What usually governs timing for generic erosion (structural drivers)?

• Orange Book “listed drug” patents: composition of matter patents typically set the earliest legal barrier.
• Use and dosing patents: can add barriers depending on claim scope and whether generic labels carve around them.
• Regulatory exclusivities: can bar ANDA approval until expiration even if a patent expires, depending on the exclusivity type.
• Paragraph IV litigation: automatic stays after notice can delay launch even when a patent is challenged.

(Note: Specific end dates depend on Orange Book entries for ELIQUIS and the controlling patents for each dosage strength. This analysis is framed on the legal structure governing ELIQUIS erosion risk.)

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What patents protect ELIQUIS in the US (composition, formulation, and method-of-use)?

Quick answer: ELIQUIS protection is typically anchored by apixaban composition-of-matter claims and is supplemented by additional Orange Book-listed patents that cover dosing regimens and specific therapeutic uses for AF and VTE settings.

How to think about ELIQUIS patent estate strength for generics

• Composition-of-matter: usually the highest-impact barrier.
• Method-of-use/dosing: important if claim scope covers a labeled regimen that generics would need to match or carve out.
• Formulation and manufacturing: affects risk for “non-infringing alternatives” and could raise development and approval friction if claims cover specific release, stability, or processing.

Who typically holds and enforces the estate

• Brand sponsor and assignees that control Orange Book-listed patents, which in small-molecule anticoagulants usually include the innovator and related patent-holding entities.
• Litigation posture often reflects willingness to defend around core composition and dosing claims.

(Specific patent numbers, assignees, and expiration dates are not provided here because the analysis cannot be completed without the Orange Book patent list and the authoritative litigation docket for ELIQUIS as of the current date.)

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How do Paragraph IV ANDA challenges affect ELIQUIS launch risk and cash-flow volatility?

Quick answer: Paragraph IV challenges drive settlement probability and can produce either delayed generic entry via stays or step-change cash-flow volatility around settlement milestones and final exclusivity expiration.

Common financial effects from Paragraph IV cycles

• Cost volatility: legal fees, milestone payments, and settlement terms can affect quarterly earnings.
• Pricing volatility: innovators often maintain tighter pricing when launch risk rises and then adjust after outcomes.
• Channel preparation: wholesalers and payers shift procurement planning in anticipation of launch, changing branded demand timing.

How settlements typically structure market outcomes

• “Do not launch until” dates tied to patent expiry.
• Design-around or label carve-outs where generics agree not to market for certain indications until further legal clearance.
• Brand marketing concessions in some deals via formulary commitments or managed entry agreements.

(Specific settlement agreements, case numbers, and launch dates are not enumerated because a complete docket and deal list cannot be compiled in this response.)

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What generic entry scenarios are most credible for ELIQUIS?

Quick answer: The most credible pathway for branded erosion is a US generic ANDA launch at or shortly after the earliest relevant Orange Book barrier for the highest-demand strength and labeled indications, with launch economics depending on whether the generic can compete on net price and formulary access.

Scenario framework

• Best-case for generics: narrow scope carve-outs plus earlier-than-expected resolution of stays.
• Base-case for brand: litigation delay and/or multiple patents extending protection beyond the first expiry.
• Worst-case for brand: rapid legal resolution with broad label coverage and immediate formulary substitution in large payer contracts.

What strengths and dosage forms matter most

• Higher-demand strengths can drive most branded share.
• If generic entry begins with a subset of strengths, branded sales may erode more slowly due to incomplete substitution.

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What is the Orange Book status of ELIQUIS and which dosage strengths are most exposed?

Quick answer: Orange Book status is dosage-strength dependent because listed patents can be tied to the specific strength or NDA listing. The earliest-expiring listed patent for a given strength and formulation drives exposure.

Why dosage-strength matters

• ANDA comparability: generics must match the listed drug reference (strength/form).
• Payer switching behavior: formularies can switch by strength and step-therapy rules.
• Copayment dynamics: patient out-of-pocket costs influence persistence and real-world switching speed after generic launch.

(Orange Book line-item details are not provided in this response due to the lack of a verified, up-to-date Orange Book extract.)

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How do ELIQUIS financial drivers differ by indication (AF vs VTE)?

Quick answer: AF is the higher persistence engine, while VTE has more episodic demand. A shift in AF volume or persistence has a more direct impact on baseline revenue, whereas VTE changes can create seasonal or event-driven volatility.

Atrial fibrillation (AF)

• High-frequency long-term therapy: supports steady refill patterns.
• Switching constraints: prescribers tend to keep stable anticoagulation unless prompted by formulary change or patient-specific risk.

VTE treatment and prevention

• Procedure and hospitalization linkage: VTE utilization rises with surgeries and acute care volumes.
• Shorter regimen windows: affects quarterly script timing and faster substitution during price pressure.

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How strong is the ELIQUIS patent estate versus Xarelto (rivaroxaban)?

Quick answer: Both are high-value DOAC franchises with layered small-molecule patent portfolios. The practical determinant of relative strength is whether each brand’s earliest-expiring, most-asserted Orange Book patents are enforceable against the leading generic candidates and whether method-of-use claims prevent label carve-outs.

Key comparative factors

• Earliest composition-of-matter expiry date.
• Number of Orange Book-listed patents still in force across major strengths.
• Whether enforceable method-of-use claims exist that constrain generic labeling.
• Litigation count and frequency of Paragraph IV challenges.

(A side-by-side patent table is omitted because full Orange Book datasets for ELIQUIS and Xarelto are required to avoid inaccuracies.)

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What litigation and settlement milestones have mattered for ELIQUIS (and why they move the stock/revenue narrative)?

Quick answer: ELIQUIS litigation milestones typically affect branded revenue expectations through (1) probability of generic launch timing, (2) likelihood of settlement-driven launch constraints, and (3) uncertainty discounting during litigation stays.

Milestone types that change the commercial outlook

• Court decisions affecting the validity or infringement of key claims.
• Settlement agreements that set a “carve-out” or “launch moratorium” window.
• Appeals affecting when stays lift.

(Case-by-case milestones are not listed here because a verified docket compilation is not available in this response.)

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What FDA regulatory status and labeling scope affects ELIQUIS market demand?

Quick answer: FDA labeling breadth in AF and VTE anchors demand. Label stability matters for switching because payers and prescribers use indication-specific evidence when designing formularies and clinical pathways.

How label scope influences utilization

• Broader indication coverage increases patient pools.
• Dosing regimen clarity affects clinician comfort and contributes to adherence.
• Safety communications can change utilization at the margin, especially in bleeding-risk subgroups.

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Where does ELIQUIS face biosimilar-like risk, and how does it differ from biologics?

Quick answer: Biosimilar dynamics do not apply. The competitive risk is generic small-molecule substitution and potential incremental DOAC competition rather than biologic biosimilar entry.

Practical substitute classes

• Generic apixaban (ANDA pathway).
• Other DOACs (e.g., rivaroxaban, dabigatran, edoxaban) via formulary substitution.
• Warfarin and LMWH in contraindicated or cost-constrained settings.

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What is the revenue trajectory for ELIQUIS and what should investors model?

Quick answer: ELIQUIS revenue trajectory is modeled as a combination of (1) baseline script growth and persistence, (2) net price trajectory reflecting PBM rebates and competition, and (3) step-change effects from generic erosion timing and formulary switches.

How investors typically model branded DOAC revenue into the future

• Base case: modest growth or stability from AF persistence plus gradual mix expansion.
• Downside case: earlier-than-expected generic availability for an important strength, causing price compression and formulary substitution.
• Upside case: delayed erosion and sustained preferred placement driven by contract economics.

Key forecast sensitivities

• Timing of earliest Orange Book and exclusivity barrier expiry for the highest-demand dosage strength.
• Post-approval settlement date versus court timelines.
• PBM formulary behavior and patient copay steering after generic launch.

(Numeric revenue figures are not provided because an accurate, dated financial trajectory requires validated company filings and segment reporting for ELIQUIS, which cannot be asserted in this response.)

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Key Takeaways

• ELIQUIS revenue is primarily driven by AF persistence and VTE episodic demand, with net revenue shaped by PBM rebate contracts and formulary tiering.
• Competitive pressure comes from within-class DOAC substitution, especially when payer contracting tilts toward Xarelto or lower-cost alternatives.
• Generic erosion risk is governed by Orange Book-listed patents, regulatory exclusivities, and Paragraph IV litigation stays and settlements.
• The most financially material events are the resolution of controlling patent barriers and the practical timing of generic launches at the highest-demand strength.

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FAQs

1) What drives ELIQUIS demand in atrial fibrillation compared with venous thromboembolism?
AF demand is persistence-led; VTE demand is episodic and tied to acute care and procedures.

2) How do PBM formulary changes usually affect ELIQUIS net pricing?
They change rebate leverage and tier placement, typically accelerating net price compression when preferred status shifts.

3) What is the difference between Orange Book patent expiry and exclusivity expiry for ELIQUIS?
Orange Book patents can block approval until expiry or successful litigation; exclusivity can also bar approval even if patents expire, depending on the exclusivity type.

4) What legal mechanism is most relevant to generic apixaban entry?
Paragraph IV ANDA challenges to Orange Book-listed patents and subsequent litigation that can trigger stays.

5) Does biosimilar competition threaten ELIQUIS like it does biologics?
No. ELIQUIS faces generic small-molecule substitution and DOAC class competition, not biosimilar entry dynamics.

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References (APA)

1. US Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.

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