ELIQUIS Drug Patent Profile

« Back to Dashboard

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.

The generic ingredient in ELIQUIS is apixaban. There is one drug master file entry for this compound. Eight 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

US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	77
Patent Applications:	4,065
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
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
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	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
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

Eliquis Market Dynamics, Patent Timeline, Financial Trajectory, and Generic Entry Risk

Last updated: October 9, 2026

Eliquis, the apixaban anticoagulant marketed by Bristol Myers Squibb and Pfizer, generated approximately $13.3 billion in Bristol Myers Squibb worldwide sales in 2024, making it one of the company’s largest products. Demand remains strong because of its position in atrial fibrillation and venous thromboembolism treatment, but the product faces concentrated U.S. patent risk, Medicare price negotiation, and expected generic entry beginning in 2028 under settlement agreements.

The commercial outlook has two phases: continued growth through 2025, followed by a sharp U.S. revenue decline after generic launch. The core composition patent expires in 2026, while a later formulation patent has been listed through 2031. Generic manufacturers have settled Paragraph IV litigation with launch rights generally beginning April 1, 2028.

What is Eliquis and how large is its market?

Eliquis is the brand name for apixaban, an oral direct factor Xa inhibitor. Bristol Myers Squibb and Pfizer developed and commercialized the product through their alliance. The FDA approved Eliquis in 2012 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The FDA later approved it for treatment and prevention of deep vein thrombosis and pulmonary embolism, including prevention of postoperative venous thromboembolism after hip or knee replacement surgery. [1]

The product competes primarily with:

• Xarelto, or rivaroxaban, marketed by Johnson & Johnson and Bayer
• Pradaxa, or dabigatran, marketed by Boehringer Ingelheim
• Warfarin, a low-cost generic anticoagulant
• Injectable anticoagulants such as enoxaparin

Eliquis has maintained strong prescription demand because of clinical use across several indications, broad physician familiarity, twice-daily dosing, and the established direct oral anticoagulant market.

Eliquis competitive position

Product	Active ingredient	Drug class	Principal companies	Generic status
Eliquis	Apixaban	Factor Xa inhibitor	Bristol Myers Squibb, Pfizer	No broad U.S. generic launch before 2028 under current settlements
Xarelto	Rivaroxaban	Factor Xa inhibitor	Johnson & Johnson, Bayer	U.S. generic entry expected after patent settlements in 2026
Pradaxa	Dabigatran	Direct thrombin inhibitor	Boehringer Ingelheim	Generic competition is available in the U.S.
Coumadin and generic warfarin	Warfarin	Vitamin K antagonist	Multiple companies	Long-established generic
Lovenox and generic enoxaparin	Enoxaparin	Low-molecular-weight heparin	Sanofi and generic manufacturers	Generic and authorized-generic competition

Eliquis has benefited from the clinical shift away from warfarin toward direct oral anticoagulants. That market shift supports volume, but it also makes the product one of the largest targets for generic manufacturers.

How much revenue does Eliquis generate?

Bristol Myers Squibb’s reported worldwide Eliquis sales increased from approximately $10.1 billion in 2021 to $13.3 billion in 2024. [2-5]

Year	Bristol Myers Squibb Eliquis revenue	Year-over-year change
2021	Approximately $10.1 billion	N/A
2022	Approximately $11.8 billion	Approximately 17%
2023	Approximately $12.6 billion	Approximately 7%
2024	Approximately $13.3 billion	Approximately 5%

Bristol Myers Squibb reported total 2024 revenue of approximately $48.3 billion. Eliquis therefore represented about 27% of the company’s total revenue, before considering alliance economics and product-level profitability. [5]

Pfizer reports its economic share separately from Bristol Myers Squibb. The companies’ reporting structures differ, so Pfizer’s Eliquis revenue cannot be added directly to Bristol Myers Squibb’s product-sales figure without adjustment. Pfizer’s 2024 annual report continued to identify Eliquis as one of its major alliance products. [6]

What is driving Eliquis revenue growth?

The main growth drivers are:

1. Continued adoption of direct oral anticoagulants in atrial fibrillation.
2. Expansion and sustained use in treatment and secondary prevention of venous thromboembolism.
3. Higher diagnosis rates for atrial fibrillation and thromboembolic disease.
4. Prescription persistence among older patients.
5. Broad reimbursement coverage before full Medicare price negotiation takes effect.

Growth has slowed from the product’s earlier launch period. The product is mature in the U.S. and faces increasing payer pressure, but international volume and continued category expansion have supported sales.

When does Eliquis lose exclusivity?

Eliquis has two important U.S. patent layers: the original apixaban composition patent and a later formulation patent listed in the FDA Orange Book.

U.S. patent	General subject matter	Listed expiration or reported term	Commercial significance
US 6,967,208	Apixaban compound and related chemical claims	February 23, 2026, with possible pediatric extension	Primary composition patent
US 9,326,945	Pharmaceutical composition containing apixaban	December 12, 2031	Later formulation protection and principal settlement leverage

The FDA Orange Book is the controlling regulatory reference for patents submitted by the NDA holder, but patent listing does not by itself determine whether a patent will survive litigation or block an ANDA. [7]

The effective commercial loss-of-exclusivity date is later than the 2026 composition-patent expiration because Bristol Myers Squibb and Pfizer reached settlements with several generic applicants. Those agreements generally permit commercial launch on April 1, 2028, subject to the individual agreement terms and regulatory status of each applicant.

What formulations are protected by Eliquis patents?

The later Eliquis patent covers pharmaceutical compositions containing apixaban. Formulation claims can create a separate barrier even after expiration of the compound patent if a generic applicant relies on a formulation that falls within the listed claims.

The formulation patent is commercially important for three reasons:

• It extends listed patent protection beyond the compound patent.
• It provides a basis for Paragraph IV litigation against ANDA filers.
• It gives the branded companies leverage to negotiate delayed-entry settlements.

Generic companies can attempt to avoid infringement by designing alternative formulations, challenging patent validity, or using claim-construction arguments. The commercial value of that strategy depends on whether the FDA accepts the ANDA and whether the formulation avoids the Orange Book patent claims.

Which companies are challenging Eliquis patents?

Multiple generic drug companies filed Abbreviated New Drug Applications with Paragraph IV certifications against Eliquis patents. Publicly reported defendants and potential applicants have included major and specialty generic manufacturers such as:

• Teva Pharmaceuticals
• Mylan, now part of Viatris
• Sandoz
• Sun Pharmaceutical Industries
• Zydus Pharmaceuticals
• Hetero
• Apotex
• Micro Labs
• Sigmapharm
• Alembic Pharmaceuticals

The exact defendant group has changed as companies settled, transferred rights, or resolved individual cases. Paragraph IV certification alleges that a listed patent is invalid, unenforceable, or not infringed. The filing of a Paragraph IV notice generally triggers a 30-month stay of FDA approval under the Hatch-Waxman Act, subject to statutory exceptions and court developments.

What is the status of Eliquis Paragraph IV litigation?

Bristol Myers Squibb and Pfizer brought patent infringement actions against multiple ANDA applicants in the U.S. District Court for the District of Delaware. The cases focused on apixaban composition and formulation patents.

The principal commercial outcome has been settlement rather than immediate generic launch. Publicly reported settlements permit generic Eliquis entry beginning April 1, 2028. The settlements reduce the risk of an earlier launch while giving generic companies a defined entry date.

The settlements do not eliminate all litigation risk. A generic applicant could challenge a patent outside the settlement framework, and a court could invalidate or narrow a listed patent. The practical risk is lower than the risk indicated by the 2026 composition-patent expiration alone because most major applicants have agreed to delayed entry.

What is the Orange Book status of Eliquis?

The FDA Orange Book lists Eliquis under NDA 202155, held by Bristol-Myers Squibb Company. The listed drug contains apixaban in 2.5-milligram and 5-milligram tablets.

The principal Orange Book patent issues are:

• Composition protection associated with US 6,967,208.
• Formulation protection associated with US 9,326,945.
• Paragraph IV certifications submitted by ANDA applicants.
• Regulatory stays and settlement terms affecting approval timing.

An Orange Book patent listing does not guarantee enforceability. Generic applicants can challenge listed patents through Paragraph IV litigation, inter partes review, district-court invalidity claims, or noninfringement arguments.

How does Medicare price negotiation affect Eliquis?

Eliquis is among the first 10 drugs selected for Medicare price negotiation under the Inflation Reduction Act. The Centers for Medicare & Medicaid Services negotiated a maximum fair price of $231 for a 30-day supply, effective January 1, 2026. CMS stated that the negotiated price represents a substantial reduction from the product’s list price. [8]

The Medicare price will affect Eliquis before expected generic launch in 2028. The principal effects are:

• Lower government-reimbursed prices for Medicare Part D prescriptions.
• Reduced gross-to-net revenue in the U.S.
• Pressure on commercial payers to seek comparable discounts.
• Lower revenue per prescription even if prescription volume remains stable.
• Greater sensitivity of Bristol Myers Squibb’s 2026 and 2027 forecasts to payer mix.

The impact on total company revenue will depend on Medicare utilization, negotiated-price adoption, rebates, patient assistance, and international sales. Eliquis remains commercially important because Medicare patients represent a large portion of the atrial fibrillation population.

What generic entry scenarios exist for Eliquis?

Base case: April 2028 launch

The most likely scenario is coordinated or staggered generic entry beginning April 1, 2028. Several approved or approvable ANDAs could launch near the settlement date, producing rapid price erosion.

The first 12 months would likely involve:

• Multiple suppliers entering simultaneously.
• Pharmacy benefit manager contracting pressure.
• Rapid decline in branded U.S. prescriptions.
• Substantial reduction in net price.
• Retention of some brand demand among patients and prescribers.

Earlier-entry scenario

Earlier entry could occur if a court invalidates the later formulation patent, an applicant prevails on noninfringement, or a settlement does not bind a particular applicant. This scenario would materially increase revenue risk, but the current settlement structure reduces its probability.

Delayed-entry scenario

Entry could be delayed by FDA approval issues, manufacturing deficiencies, unresolved litigation, or commercial decisions by ANDA applicants. Multiple approved generic suppliers would make a prolonged delay unlikely once the settlement date arrives.

How strong is the Eliquis patent estate?

The Eliquis patent estate is commercially strong through the late 2020s but has limited long-term durability after generic entry begins.

Strength factor	Assessment
Composition patent	Strong historical protection, but expiration is near
Formulation patent	Important secondary barrier with a 2031 listed expiration
ANDA litigation	Effective in producing delayed-entry settlements
Settlement control	Strong, with major applicants reportedly tied to 2028 entry
Regulatory exclusivity	No remaining new-drug exclusivity barrier comparable to the patent estate
Manufacturing barrier	Moderate; apixaban tablets are technically manageable for established generic manufacturers
Long-term durability	Limited after multiple generics enter

Apixaban is a small molecule, not a biologic. Biosimilar regulation therefore does not apply. Generic manufacturers use the ANDA pathway rather than the 351(k) biosimilar pathway.

Manufacturing is unlikely to create a durable barrier comparable to those found in complex biologics, sterile injectables, or device-integrated products. The main challenges are active pharmaceutical ingredient quality, bioequivalence, tablet manufacturing, supply reliability, and regulatory approval.

How does Eliquis compare with Xarelto’s patent risk?

Eliquis and Xarelto are both large direct oral anticoagulants, but their loss-of-exclusivity timing differs.

Factor	Eliquis	Xarelto
Active ingredient	Apixaban	Rivaroxaban
Major manufacturers	Bristol Myers Squibb, Pfizer	Johnson & Johnson, Bayer
Core U.S. patent exposure	2026	Earlier generic entry expected
Major commercial settlement date	April 1, 2028 for reported settlements	Generic entry expected in 2026 under reported settlements
Medicare negotiated price	$231 per 30-day supply beginning 2026	Also selected for negotiation
Generic pathway	ANDA	ANDA
Biosimilar exposure	None	None

Eliquis may retain a temporary market advantage if Xarelto generics enter earlier. After Eliquis generics launch, payer formularies could shift toward lower-cost apixaban and rivaroxaban products, intensifying price competition across the category.

What licensing deals support Eliquis commercialization?

Eliquis is commercialized through the Bristol Myers Squibb-Pfizer alliance. The companies collaborated on development and share commercial economics across territories under their alliance agreements. The relationship gives Eliquis broad global commercialization capacity but also divides product economics between two companies.

For Bristol Myers Squibb, the alliance has produced a large revenue stream but reduces the portion of product economics retained by the company compared with a wholly owned product. For Pfizer, Eliquis is a major alliance asset within its cardiovascular portfolio.

The alliance also creates coordinated incentives to defend patents, negotiate settlements, manage payer contracting, and maximize revenue before generic entry.

What is the Eliquis revenue outlook?

Eliquis revenue should remain resilient through 2025, but the 2026-2028 period contains several overlapping pressures:

1. Medicare negotiated pricing begins in 2026.
2. The core composition patent expires in 2026.
3. Commercial payers will anticipate generic entry.
4. Generic settlements permit launch in 2028.
5. Multiple manufacturers may enter at approximately the same time.

A reasonable commercial trajectory is:

Period	Expected market condition
2025	Continued high revenue, with mature-market growth
2026	Medicare price pressure and increasing loss-of-exclusivity discounts
2027	Pre-generic contracting and payer migration
2028	Generic launch and rapid U.S. net-price erosion
2029 onward	Lower branded revenue, with residual brand demand and international contribution

The largest financial risk is U.S. revenue compression rather than complete global product disappearance. Eliquis should continue generating international and residual branded sales after generic entry, but the product’s contribution to Bristol Myers Squibb’s earnings will decline materially.

Key Takeaways

• Eliquis generated approximately $13.3 billion in Bristol Myers Squibb worldwide sales in 2024.
• It represented roughly 27% of Bristol Myers Squibb’s total 2024 revenue.
• The principal composition patent expires in 2026, while a later formulation patent is listed through 2031.
• Major generic manufacturers have settled Paragraph IV litigation with reported launch rights beginning April 1, 2028.
• Eliquis is an ANDA generic-risk product, not a biosimilar-risk product.
• Medicare negotiated pricing of $231 for a 30-day supply begins in 2026.
• Revenue should remain strong through 2025 but face progressive pressure from Medicare pricing, payer contracting, and anticipated generic entry.
• The most material downside is rapid U.S. price erosion after multiple generic manufacturers launch.

FAQs

Is apixaban the same drug as Eliquis?

Yes. Apixaban is the active ingredient in Eliquis. Eliquis is the branded product marketed by Bristol Myers Squibb and Pfizer.

Will Eliquis become generic in 2026?

The core composition patent expires in 2026, but reported settlements with major generic applicants generally permit commercial launch beginning April 1, 2028.

Is Eliquis protected by a formulation patent?

Yes. US 9,326,945 covers pharmaceutical compositions containing apixaban and has been listed with an expiration date in 2031.

Are there Eliquis biosimilars?

No. Eliquis is a chemically synthesized small-molecule drug. Competition proceeds through the FDA’s ANDA generic-drug pathway, not the biosimilar pathway.

How much revenue could Bristol Myers Squibb lose after Eliquis generic entry?

The amount depends on generic timing, price erosion, Medicare utilization, international sales, and residual brand demand. Because Eliquis represented approximately 27% of Bristol Myers Squibb’s 2024 revenue, the product is one of the company’s largest post-2027 revenue exposures.

References

1. U.S. Food and Drug Administration. (2012). Eliquis approval letter and prescribing information. FDA.

2. Bristol Myers Squibb. (2022). 2021 annual report. Bristol Myers Squibb.

3. Bristol Myers Squibb. (2023). 2022 annual report. Bristol Myers Squibb.

4. Bristol Myers Squibb. (2024). 2023 annual report. Bristol Myers Squibb.

5. Bristol Myers Squibb. (2025). 2024 annual report. Bristol Myers Squibb.

6. Pfizer Inc. (2025). 2024 annual report. Pfizer.

7. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

8. Centers for Medicare & Medicaid Services. (2024). Medicare drug price negotiation program: Negotiated prices for the first 10 drugs. U.S. Department of Health and Human Services.

DrugChatter Q&A for ELIQUIS

Eliquis und ibuprofen?
Eliquis ibuprofen?
Eliquis and dental cleaning?
Will there be a generic for eliquis in 2026?
When does the patent expire for alex eliquis?