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. Ten 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:	7
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
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

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	6,413,980
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	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
South Africa	200402184	LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS
Hungary	228195	LACTAM DERIVATIVES HAVING A PYRAZOLO-PYRIDINE RING AND PHARMACEUTICAL COMPOSITIONS THEREOF AS FACTOR XA INHIBITORS
Norway	328558

Supplementary Protection Certificates for ELIQUIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	443	Finland
1427415	122011100050	Germany		PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	CA 2011 00028	Denmark

Market Dynamics and Financial Trajectory of Eliquis (Apixaban)

Last updated: January 10, 2026

Executive Summary

Eliquis (apixaban), developed by Bristol-Myers Squibb (BMS) and Pfizer, stands as a leading oral anticoagulant in the global market. Its innovative mechanism—factor Xa inhibition—has supported versatile indications including atrial fibrillation (AF), venous thromboembolism (VTE), and post-operative prophylaxis. The drug's robust regulatory approvals, expanding clinical uses, and strategic marketing have contributed to impressive sales growth, positioning it as a top competitor against rivaroxaban (Xarelto) and dabigatran (Pradaxa). Market forecasts project continued expansion driven by aging populations, rising cardio-vascular disease prevalence, and ongoing clinical trials. However, patent cliffs, generic entry, and competitive pressures pose risks to future revenue streams. This report comprehensively analyzes the current market landscape, financial trajectory, key drivers, challenges, and future outlook for Eliquis.

---

What Are the Core Market Drivers for Eliquis?

Increasing Prevalence of Targeted Conditions

Condition	Global Incidence (2019)	Projected Growth (2020-2030)	Drivers
Atrial Fibrillation (AF)	37.5 million (WHO)	CAGR ~8%	Aging populations, lifestyle factors
Venous Thromboembolism (VTE)	1-2 million annually	Growth in surgical and cancer-associated VTE	Surgical procedures, cancer rates
Post-operative Thromboprophylaxis	Increasing surgical volumes	Improving surgical techniques	Global surgical volume increase

Source: WHO, Globocan 2020

The uptick in cardiovascular and thrombotic conditions amplifies the demand for oral anticoagulants, underpinning Eliquis' market growth.

Regulatory Approvals and Expanded Indications

Year	Key Milestones	Implication
2012	FDA approval for non-valvular AF	Entry into a massive, lucrative market
2014	EMA approval for VTE treatment	Broadened usage envelope
2020	FDA approval for pediatric VTE	Extended patient demographic

Regulatory endorsements bolster market penetration across diverse patient subsets.

Competitive Landscape

Major Competitors	Market Share (2022)	Key Differentiators
Eliquis	~35%	Favorable bleeding profile, multiple indications
Rivaroxaban (Xarelto)	~30%	Once-daily dosing, wide approval spectrum
Dabigatran (Pradaxa)	~10-15%	Reversal agent availability, initial market entrant

Source: IQVIA, 2022; EvaluatePharma

Positioning Eliquis as a preferred agent for its efficacy and safety profile drives market momentum.

---

Financial Trajectory and Revenue Analysis

Historical Revenue Growth (2018-2022)

Year	Total Sales (USD Millions)	Year-over-Year Growth	Key Factors
2018	$3.1 billion	N/A	Launch phase, expanding indications
2019	$4.4 billion	+41.9%	Approval for VTE, broader patient use
2020	$6.0 billion	+36.4%	COVID-19 pandemic impact, hospitalization trends
2021	$7.1 billion	+18.3%	Regulatory approvals, market expansion
2022	$8.0 billion (estimated)	+12.7%	Continued growth, patent expiry concerns

Source: Bristol-Myers Squibb and Pfizer quarterly reports

Forecasted Revenue Trajectory (2023-2027)

Year	Estimated Sales (USD Billions)	CAGR	Key Drivers
2023	$8.4 billion	+5%	Mature market plateauing but expanding indications
2024	$8.9 billion	+6%	Increased adoption in emerging markets
2025	$9.4 billion	+6%	Approvals for new indications, refill cycles
2026	$10.0 billion	+7%	Entry into new patient segments, biosimilars threat
2027	$10.6 billion	+6%	Growth stabilization, patent exclusivity nearing end

Patent and Market Entry Challenges

Year	Patent Expiry	Impact on Revenue	Expected Generic Entry
2026	US patent expiring	Revenue erosion risk	Emerging generics anticipated in 2026-2028

The impending patent cliff could precipitate revenue declines, necessitating pipeline diversification.

---

Key Market Opportunities

Expansion into Emerging Markets

Region	Current Penetration	Growth Opportunities	Strategic Actions
Asia-Pacific	~20% of global sales	Large patient population, rising disposable income	Local partnerships, regulatory navigation
Latin America	Moderate	Increasing cardiovascular screening programs	Market-specific marketing strategies

Development of New Indications

Indication	Status	Potential Revenue Impact	Supporting Clinical Trials
Cancer-associated thrombosis	Phase 3	$1.2 billion (estimated)	APPRAISE and CarAVaH studies
Pediatric thrombosis	Approved	Niche segment, expanding addressability	Clinical safety and dosage data

Pharmacoeconomic and Reimbursement Strategies

Cost-effectiveness analyses favor Eliquis due to lower bleeding risks, supporting reimbursement expansions in health systems globally.

---

Challenges and Risks to Financial Growth

Generic Competition and Price Erosion

Timeline	Anticipated Generic Entry	Market Impact	Mitigation Strategies
2026+	Multiple generics	Potential 50-70% revenue decline	Diversify pipeline, JVs, premium indications

Clinical and Regulatory Risks

• Safety concerns or adverse events could limit label extensions.
• Stringent cost-control policies may restrict reimbursement.

Market Saturation and Patient Switching

• Diminishing marginal sales as maximum market penetration approaches.
• Competition offers similar efficacy with lower costs.

---

Future Outlook and Strategic Considerations

Focus Area	Strategic Recommendations
Pipeline Expansion	Accelerate trials for new indications like cancer thromboembolism
Geographic Expansion	Prioritize high-growth regions such as Asia-Pacific and Africa
Lifecycle Management	Develop fixed-dose combinations, biosimilars, and personalized dosing algorithms
Partnership and Licensing	Establish collaborations to extend patent life and improve market access

Forecast Summary:
Eliquis is poised for steady growth through the next five years, albeit tempered by upcoming patent expiries and competitive pressures. Emphasizing innovation, market expansion, and lifecycle management will be critical to sustain financial momentum.

---

Key Takeaways

• Robust Growth: Eliquis achieved significant revenue increases ( CAGR ~25-30% from 2018-2022) driven by broad approval and population aging.
• Market Expansion: Emerging markets and new indications like pediatric VTE and cancer-associated thrombosis represent substantial upside.
• Patent Risks: Revenue trajectory faces potential decline post-2026 due to generic competition; early pipeline and pipeline expansion are vital.
• Competitive Position: Eliquis's favorable safety profile and expanding list of indications sustain its market leadership against rivals.
• Strategic Focus: Investment in global market penetration, clinical pipeline, and lifecycle management will determine sustained financial success.

---

FAQs

Q1: When will Eliquis's patent expire, and how will it impact sales?
Most pivotal patents in the US are expected to expire in 2026, potentially leading to a sharp decline (50-70%) in revenues due to generic competition. Strategic diversification and pipeline expansion are essential to mitigate this risk.

Q2: What are the main clinical differences between Eliquis and its competitors?
Eliquis generally demonstrates a lower risk of major bleeding compared to rivaroxaban and dabigatran, with comparable or superior efficacy for stroke prevention in AF. Its twice-daily dosing enhances compliance.

Q3: Which markets hold the most growth potential for Eliquis?
Emerging markets in Asia-Pacific and Latin America present high growth opportunities due to increasing cardiovascular disease burden and expanding healthcare infrastructure.

Q4: How does Eliquis's safety profile influence its market share?
Its favorable safety, especially regarding bleeding risks, has facilitated clinician and patient preference, supporting higher utilization and broader indications.

Q5: What role do clinical trials play in Eliquis's future prospects?
Successful outcomes in trials for indications like cancer-associated thrombosis and pediatric VTE can unlock new markets and revenue streams.

---

References

1. Bristol-Myers Squibb Financial Reports, 2018–2022.
2. IQVIA Market Data, 2022.
3. EvaluatePharma World Preview, 2022.
4. WHO Global Burden of Disease Study, 2019.
5. FDA and EMA Approval Announcements, 2012–2022.