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. Eleven 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:	8
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	77
Patent Applications:	4,127
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
VA Office of Research and Development	PHASE4
U.S. Food and Drug Administration (FDA)	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					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

Expired US Patents for ELIQUIS

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

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
World Intellectual Property Organization (WIPO)	03026652
Austria	439360
Canada	2791171	FORMULATIONS D'APIXABAN (APIXABAN FORMULATIONS)
Poland	3251660

Supplementary Protection Certificates for ELIQUIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	PA2011012,C1427415	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518
1427415	CA 2011 00028	Denmark
1427415	91888	Luxembourg		91888, EXPIRES: 20260518
1427415	2011C/034	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE

Market Dynamics and Financial Trajectory for ELIQUIS

Last updated: November 7, 2025

Introduction

ELIQUIS (apixaban), developed and marketed by Pfizer in partnership with Bristol-Myers Squibb, is a direct oral anticoagulant (DOAC) primarily indicated for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF), treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of venous thromboembolism (VTE) following hip or knee replacement surgery. Since its approval in 2012, ELIQUIS has become a significant player in the anticoagulant market, competing with traditional therapies like warfarin and novel agents such as rivaroxaban and dabigatran.

This analysis explores market dynamics shaping ELIQUIS’s growth, assesses its financial trajectory, examines competitive pressures, regulatory influences, and market expansion strategies that influence its long-term commercial prospects.

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Market Landscape of Anticoagulants

The global anticoagulant market surpasses USD 10 billion annually, driven by an aging population, increasing prevalence of atrial fibrillation, and rising incidences of VTE. Traditional drugs like warfarin face declining use due to its monitoring requirements and food interactions, leading to increased adoption of DOACs, including apixaban—ELIQUIS’s active compound.

Key competitors include rivaroxaban (Xarelto, Janssen), dabigatran (Pradaxa, Boehringer Ingelheim), and edoxaban (Lixiana, Daiichi Sankyo). The market’s evolution favors drugs with safer profiles, predictable pharmacokinetics, and fewer interactions, positioning ELIQUIS favorably due to its demonstrated efficacy and safety.

Market growth drivers:

• Global aging demographic.
• Rising awareness of non-valvular atrial fibrillation.
• Expanded indications, including secondary stroke prevention.
• Off-label use and real-world adoption.

Market Dynamics Affecting ELIQUIS

Regulatory Factors and Approvals

Since launch, ELIQUIS has secured approvals across numerous regions, including the US, EU, and Asia-Pacific, with expanding indications. The FDA and EMA approvals have been instrumental in establishing confidence among clinicians. Recent approvals for additional indications—such as secondary stroke prevention in patients with NVAF and systemic embolism—broaden ELIQUIS’s market potential.

Regulatory setbacks or delays—such as concerns over bleeding risks—can impact sales trajectories. Conversely, positive safety profile updates reinforce market positioning.

Competitive Positioning and Pricing

ELIQUIS’s efficacy, safety, and convenience have maintained its competitive edge. Its once-daily dosing (in some indications) enhances adherence, a key factor influencing prescriber choice.

Pricing strategies also influence market share. As patent life progresses, Pfizer faces generic erosion risks. However, patent exclusivity extensions and manufacturing innovations delay generic entry, supporting revenue streams.

Market Penetration and Adoption Trends

Adoption varies geographically. Developed markets exhibit high penetration, driven by physicians’ familiarity and formulary preferences. In emerging economies, logistical barriers and affordability constraints slow adoption but present growth avenues.

Clinician preference shifts favor DOACs over warfarin, given their predictable pharmacology. Clinical guidelines increasingly endorse apixaban for stroke prevention and VTE treatment, reinforcing ELIQUIS’s market positioning.

Patent Extensions and Generic Competition

Patent expiration in key markets—anticipated in the early 2030s—poses long-term revenue risks. Patent litigations and exclusivity extensions via new formulations (e.g., quadrivalent formulations or fixed-dose combinations) are strategies to sustain exclusivity.

Pharmacovigilance and Safety Profile

Safety concerns, especially bleeding risks, influence prescriber and patient choice. ELIQUIS's favorable bleeding profile compared to warfarin underpins its growing market share. Ongoing surveillance and real-world evidence support its safety claims, reinforcing usage.

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Financial Trajectory of ELIQUIS

Revenue Trends

Since its FDA approval in 2012, ELIQUIS has experienced rapid growth. Pfizer reports consistent sales increases, with revenues surpassing USD 3 billion annually in recent years (e.g., USD 3.2 billion in 2022).

The drug’s revenue growth has been driven by escalating adoption across indications, alongside solid market penetration in North America, Europe, and parts of Asia.

Market Share and Revenue Drivers

ELIQUIS holds approximately 30-40% of the global DOAC market share, competing closely with rivaroxaban. Its success partly stems from its robust clinical trial data (ARISTOTLE, AMPLIFY), which demonstrated superior efficacy and safety profiles.

Pricing remains competitive, with premium positioning justified by clinical benefits. The ongoing expansion into new indications and off-label uses substantially contribute to revenue growth.

Impact of Patent Expirations

Upcoming patent expirations, expected around 2026-2028, threaten revenue stability due to the anticipated entry of biosimilars or generics. Pfizer and partners have initiated strategies such as pipeline diversification, formulation improvements, and strategic collaborations to mitigate these risks.

Downstream Market and Volume Growth

Market expansion into emerging markets, coupled with increased awareness, fuels volume growth. Strategic partnerships with health systems aim to improve access and adherence, further propelling sales.

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Strategic Growth Opportunities

New Indications and Label Expansion

Clinical trials investigating ELIQUIS for additional indications—such as prophylaxis in orthopedic surgeries and cancer-associated thrombosis—could unlock new revenue streams. Regulatory approvals for these indications would bolster market share.

Geographical Penetration

Targeted expansion into Asia-Pacific and Latin America offers vast growth potential, driven by rising cardiovascular disease prevalence. Building local manufacturing capacity and navigating regional regulatory pathways are critical success factors.

Combination Therapies and Formulation Innovation

Development of fixed-dose combinations with other cardiovascular agents enhances therapy adherence. Novel formulations, such as subcutaneous delivery or extended-release versions, could reinforce competitive advantage.

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Market Challenges and Risks

Generic Competition

Patent expiry may introduce biosimilars, eroding market share. Pfizer’s proactive strategies, including patent extensions, are essential for revenue continuity.

Safety Concerns and Market Perception

Adverse event reports, especially related to bleeding, require continuous safety monitoring. Negative safety perceptions can dampen demand and impact sales.

Pricing and Reimbursement Pressures

Healthcare systems globally are demanding cost-effective therapies. Price reductions and reimbursement constraints could reduce profit margins.

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Conclusion: Outlook and Strategic Insights

ELIQUIS’s market outlook remains robust owing to its established efficacy, safety profile, and expanding indications. Despite impending patent expirations, strategic initiatives—such as pipeline innovation and geographic expansion—serve as pillars for sustained growth.

The evolving competitive landscape necessitates continuous clinical and regulatory success, proactive market access strategies, and innovation in formulation and delivery methods. Pfizer’s focus on expanding ELIQUIS’s footprint in emerging markets and exploring new indications holds promise for maintaining its market leadership.

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Key Takeaways

• Market leadership in the DOAC segment is reinforced by strong clinical data, safety profile, and clinician preference.
• Patent expiration risk underscores the importance of pipeline development, formulation innovation, and strategic partnerships.
• Geographical expansion into emerging markets can significantly augment revenue streams.
• Safety and efficacy remain pivotal for long-term market share retention, with real-world evidence supporting continued adoption.
• Pricing and reimbursement strategies will influence future profitability amid increasing cost-conscious healthcare environments.

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FAQs

1. When is ELIQUIS expected to face generic competition?
Patent exclusivity is expected to end around 2026-2028 in several key markets, after which biosimilar or generic versions may enter the market, potentially impacting sales.

2. What are the primary indications for ELIQUIS?
ELIQUIS is primarily approved for stroke prevention in NVAF, treatment and secondary prevention of DVT/PE, and prophylaxis post-orthopedic surgery.

3. How does ELIQUIS compare to rivaroxaban in the market?
ELIQUIS and rivaroxaban are leading DOACs with comparable efficacy, but ELIQUIS has demonstrated a slightly better safety profile in some studies, influencing clinician choice.

4. Are there ongoing clinical trials expanding ELIQUIS’s indications?
Yes, trials are investigating ELIQUIS for additional uses, including cancer-associated thrombosis and other prophylactic indications.

5. What strategies are Pfizer employing to mitigate revenue loss from patent expiry?
Pfizer is investing in pipeline diversification, new formulations, expanding indications, geographic expansion, and strategic partnerships to sustain long-term growth.

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Sources

[1] Pfizer Annual Reports; [2] FDA Approvals Database; [3] ClinicalTrials.gov; [4] Market Research Reports (e.g., Grand View Research); [5] Industry publications and cardiovascular guidelines.