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:	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	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

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
Spain	2757603
Montenegro	P8708
Croatia	P20192064
Serbia	59810	FORMULACIJE APIKSABANA (APIXABAN FORMULATIONS)

Supplementary Protection Certificates for ELIQUIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	2011/032	Ireland		PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	2011C/034	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
1427415	443	Finland
1427415	91888	Luxembourg		91888, EXPIRES: 20260518

Market Dynamics and Financial Trajectory for ELIQUIS

Last updated: February 19, 2026

ELIQUIS (apixaban), developed by Bristol-Myers Squibb and Pfizer, is a direct oral anticoagulant (DOAC) approved for stroke prevention in non-valvular atrial fibrillation (NVAF), treatment and prevention of deep vein thrombosis (DVT), pulmonary embolism (PE), and post-surgical thromboprophylaxis. Its market performance is driven by increasing anticoagulation needs, expanding indications, and competitive positioning.

Market Size and Growth

The global anticoagulant market reached approximately USD 10.9 billion in 2022, with forecasted compound annual growth rate (CAGR) of 7% through 2030[1]. ELIQUIS commanded an estimated 40% market share among DOACs in 2022, driven by its efficacy and safety profile.

Key Market Drivers

1. Atrial Fibrillation (AFib) Population: An estimated 33 million individuals globally have AFib, with the proportion requiring anticoagulation. Incidence increases with age; 9% of people over 60 have AFib[2].

2. DVT/PE Incidence: Approximately 1-2 per 1,000 individuals develop DVT or PE annually, creating opportunities for ELIQUIS in both treatment and prophylaxis.

3. Guideline Recommendations: The American Heart Association (AHA), European Society of Cardiology (ESC), and other bodies favor DOACs over warfarin for stroke prevention, enhancing ELIQUIS adoption[3].

4. Patent and Market Exclusivity: ELIQUIS's U.S. patent protection extends until around 2026, with potential for exclusivity extensions based on regulatory data exclusivity.

Market Penetration and Competition

ELIQUIS faces competition from other DOACs including:

• XARELTO (rivaroxaban): Market leader, with a 45% share.
• PRADAXA (dabigatran): Holds 10-15%.
• EDOXABAN (Savaysa): Smaller share.

The competitive landscape is characterized by overlapping indications and differing dosing schedules, influencing market share shifts.

Financial Trajectory

Bristol-Myers Squibb and Pfizer reported combined ELIQUIS revenues of approximately USD 4.3 billion in 2022. Revenue growth has averaged around 12% annually since its launch in 2012.

Revenue Breakdown

Year	Estimated Global Revenue (USD billion)	Growth Rate
2018	2.8	15%
2019	3.4	21%
2020	3.8	12%
2021	4.0	5%
2022	4.3	7.5%

The recent slowdown reflects market saturation and generic entry discussions post-patent expiry. However, ongoing expansion into additional indications (e.g., acute coronary syndromes) and geographic markets supports future growth.

Key Revenue Growth Drivers

• Expansion into New Indications: ELIQUIS secured approval in Europe for secondary prevention post-percutaneous coronary intervention (PCI) in combination with antiplatelet therapy, expected to generate additional sales.
• Geographic Expansion: Markets in Asia and Latin America exhibit rising adoption due to increasing cardiovascular disease burden and updated guidelines.
• Pricing Strategies: Premium pricing persists, but sensitive reimbursement negotiations influence net revenues, especially in emerging markets.

Future Outlook

The NDA filings for ELIQUIS in stroke prevention in patients with valvular atrial fibrillation and for venous thromboembolism treatment are under review or planned, which could broaden its approved uses.

Generic ELIQUIS approval, expected post-2026, may disrupt revenue streams unless lifecycle extension strategies such as dosing innovations or label expansions are successfully implemented.

Risks and Uncertainties

• Patent Litigation and Exclusivity: Patent challenges or invalidations could accelerate generic entry.
• Regulatory Changes: Shifts in guideline recommendations or reimbursement policies in key markets could impact sales.
• Market Competition: Entry of biosimilars or new anticoagulants with superior profiles might erode market share.
• Safety Profiles: Adverse events, such as bleeding risks, influence prescriber confidence and patient adherence.

Conclusion

ELIQUIS maintains a significant share of the DOAC market, with growing revenues buoyed by expanding indications, geographic expansion, and the global increase in atrial fibrillation and thromboembolic events. The brand faces patent expiration pressures and stiffening competition, which could affect its market trajectory beyond 2026. Strategic pipeline development and geographic penetration remain critical to sustaining its market position.

Key Takeaways

• ELIQUIS commands approximately 40% of the global DOAC market, with revenues close to USD 4.3 billion in 2022.
• Market expansion into additional indications and regions underpins growth prospects.
• Patent expiry around 2026 poses a significant risk of generic competition, potentially impacting revenues.
• Competition from other DOACs like XARELTO remains intense, requiring differentiation through new indications.
• Regulatory and reimbursement environments are pivotal in shaping future sales trajectories.

FAQs

1. When does ELIQUIS's patent protection expire?
Patent protection in the U.S. expires around 2026, with other markets varying. Patent challenges or extensions could alter timelines.

2. What are the main indications for ELIQUIS?
Stroke prevention in non-valvular atrial fibrillation, treatment/prevention of DVT and PE, and post-surgical thromboprophylaxis.

3. How does ELIQUIS compare to competitors?
ELIQUIS has a strong safety profile and broad indication set, competing mainly with XARELLO. It has approximately 40% market share within DOACs.

4. What potential growth opportunities exist?
Expansion into acute coronary syndromes, venous thromboembolism treatment, in new regions, and approval in additional indications.

5. What risks could impact ELIQUIS's future sales?
Patent expiry, generic competition, regulatory shifts, safety concerns, and market penetration challenges.

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References

[1] MarketWatch. (2023). Anticoagulant drugs market size, share, analysis.
[2] Global Burden of Disease Study. (2019). Global prevalence of atrial fibrillation.
[3] American Heart Association. (2022). Anticoagulation guidelines for atrial fibrillation.