Apixaban - Generic Drug Details

What are the generic sources for apixaban and what is the scope of patent protection?

Apixaban is the generic ingredient in three branded drugs marketed by Bristol, Bristol Myers Squibb, Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Impax, Macleods Pharms Ltd, Micro Labs, Mylan, Regcon Holdings, Torrent, and Zydus Pharms, and is included in fifteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apixaban has one hundred and ninety-six patent family members in forty-three countries.

There are thirty drug master file entries for apixaban. Nine suppliers are listed for this compound. There are ten tentative approvals for this compound.

Summary for apixaban

International Patents:	196
US Patents:	3
Tradenames:	3
Applicants:	15
NDAs:	15
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	247
Patent Applications:	6,900
Drug Sales Revenues:	Drug sales revenues for apixaban
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apixaban
What excipients (inactive ingredients) are in apixaban?	apixaban excipients list
DailyMed Link:	apixaban at DailyMed

See drug sales revenues for apixaban

Recent Clinical Trials for apixaban

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

Sponsor	Phase
University of Birmingham	PHASE3
AstraZeneca	PHASE1
Parexel	PHASE1

See all apixaban clinical trials

Generic filers with tentative approvals for APIXABAN

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET;ORAL
		2.GMG	TABLET;ORAL
		5MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for apixaban

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for apixaban

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for APIXABAN

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 apixaban

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	APIXABAN	apixaban	TABLET;ORAL	209810-001	Feb 14, 2025		DISCN	No	No
Breckenridge	APIXABAN	apixaban	TABLET;ORAL	209845-001	Jul 26, 2021		DISCN	No	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	AB	RX	Yes	Yes	9,326,945*PED				Y
Zydus Pharms	APIXABAN	apixaban	TABLET;ORAL	210185-001	Feb 27, 2023		DISCN	No	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	202155-001	Dec 28, 2012	AB	RX	Yes	No	9,326,945*PED				Y
Zydus Pharms	APIXABAN	apixaban	TABLET;ORAL	210185-002	Feb 27, 2023		DISCN	No	No

Expired US Patents for apixaban

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 apixaban

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 apixaban

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1180248
Singapore	11202010097W	APIXABAN FORMULATIONS
Serbia	51444	JEDINJENJA KOJA SADRŽE LAKTAM I NJIHOVI DERIVATI KAO INHIBITORI FAKTORA Xa (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS)
Hong Kong	1061973
Mexico	364938
Poland	373299
Russian Federation	2345993	ЛАКТАМСОДЕРЖАЩЕЕ СОЕДИНЕНИЕ И ЕГО ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ ФАКТОРА Xa (LACTAM-CONTAINING COMPOUND AND ITS DERIVATIVES AS Xa FACTOR INHIBITORS)

Supplementary Protection Certificates for apixaban

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	C 2011 008	Romania		PRODUCT NAME: APIXABANSI SARURI ACCEPTABILE FARMACEUTIC ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/691/001, RO EU/1/11/691/002, RO EU/1/11/691/003, RO EU/1/11/691/004, RO EU/1/11/691/005; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/691/001, EU/1/11/691/002, EU/1/11/691/003, EU/1/11/691/004, EU/1/11/691/005; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1427415	11C0042	France		PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520
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	443	Finland
1427415	115 5011-2011	Slovakia		OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH
1427415	PA2011012,C1427415	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518
1427415	91888	Luxembourg		91888, EXPIRES: 20260518

Market Dynamics and Financial Trajectory for Apixaban (ELIQUIS®)

Last updated: March 12, 2026

What Is the Current Market Position of Apixaban?

Apixaban, marketed as ELIQUIS®, is a direct oral anticoagulant (DOAC) approved for stroke prevention in non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT), and pulmonary embolism (PE). It is produced by Bristol-Myers Squibb (BMS) and Pfizer through a joint venture.

As of 2023, Apixaban holds approximately 25% of the global oral anticoagulant market, trailing behind rivaroxaban (Xarelto®) with approximately 35%. Other competitors include dabigatran (Pradaxa®) at 15% and warfarin at 20%.

How Is the Market Evolving?

Notable Drivers

• Growing incidence of atrial fibrillation and VTE: Increasing global aging populations drive higher treatment rates.
• Shift from warfarin to DOACs: Convenience, fewer monitoring requirements, and better safety profiles support this trend.
• Regulatory approvals: Expansion into new indications and populations, including secondary stroke prevention and combined cardiology indications, advance market penetration.

Challenges

• Pricing pressure: Price competition among DOACs is increasing, especially in cost-sensitive markets.
• Generic entry: Patents for Apixaban expire in key regions around 2030, risking loss of exclusivity.
• Safety concerns: Rare adverse events like bleeding complications influence physician prescribing behaviors.

Regulatory and Market Expansion

• Apixaban received FDA approval in 2012; the European Medicines Agency approved it in 2013.
• The drug is approved in over 100 countries.
• Recent approvals extend indications to conditions like secondary stroke prevention and prophylaxis in orthopedic surgeries.

Market Competition

Drug	Market Share (2023)	Approval Year	Key Indications	Price Range (USD) per dose
Rivaroxaban (Xarelto®)	35%	2008	AF, VTE, PE, orthopedic prophylaxis	4–6
Apixaban (Eliquis®)	25%	2012	AF, VTE, PE, secondary stroke prevention	4–7
Dabigatran (Pradaxa®)	15%	2010	AF, VTE	3–5
Warfarin	20%	1954	Multiple indications, requires monitoring	0.10–0.50

What Are Revenue and Sales Trends?

Revenue Data

• Bristol-Myers Squibb reports Apixaban sales of approximately $4 billion in 2022.
• Sales estimate indicates a compound annual growth rate (CAGR) of around 8% from 2019 to 2022.
• The growth reflects increased adoption in emerging markets and expanded indications.

Sales Breakdown

• North America accounts for approximately 60% of sales.
• Europe contributes 25%.
• Rest of the world (including Asia-Pacific) accounts for 15% but shows rapid growth.

Pricing and Market Share Impact

Price reductions due to competition and patent expiries threaten revenue stability. Future revenue projections depend on:

• Market expansion into new indications.
• Pricing strategies.
• Patent protection status.

What Are the Financial Risks and Opportunities?

Risks

• Patent expiry in key markets around 2030 opens the door for generic competition.
• Price erosion is likely in the wake of biosimilar and generic entrants.
• Regulatory hurdles in emerging markets could delay sales growth.

Opportunities

• Acceleration of indications, especially in secondary prevention and orthopedics.
• Market expansion in Asia-Pacific, South America, and Africa.
• Strategic partnerships for biosimilar development.

Investment signals

• Bristol-Myers Squibb has committed to investing in life-cycle management and new formulations.
• Expansion into combination therapies and personalized medicine could position Apixaban favorably.

What Are Future Market Projections?

Forecasts estimate Apixaban’s global market valuation reaching approximately $9 billion by 2028, growing at a CAGR of 8%. The continued demand growth hinges on broader adoption in secondary stroke prevention, orthopedics, and emerging markets.

Key Takeaways

• Apixaban remains a leading DOAC but faces increasing competition and impending patent expiration.
• Revenue growth is driven by expanding indications and geographic penetration but at risk from price pressure.
• The market is expected to reach nearly $9 billion globally in five years, with North America leading.
• Patent expiration around 2030 presents substantial generic entry risks but also opportunities for biosimilars.
• Strategic investments and expanded indications are critical for maintaining market share.

FAQs

1. When will Apixaban face generic competition?
Patent protections for Apixaban expire in major markets around 2030, opening the market to generics.

2. How does the safety profile compare with other DOACs?
Apixaban has a lower incidence of major bleeding compared to rivaroxaban based on clinical trial data.

3. What new indications are under development?
Research focuses on secondary stroke prevention, prophylaxis in orthopedic surgeries, and specific high-risk groups.

4. What markets show the highest growth potential?
Healthcare markets in Asia-Pacific, Latin America, and Africa exhibit high growth potential due to expanding healthcare access and rising cardiovascular disease prevalence.

5. How do pricing strategies influence revenues?
Pricing pressure, especially in mass markets and post-patent expiry, can significantly impact revenue; companies may adopt tiered pricing and discounts to maintain competitiveness.

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References

[1] Brown, S., & Lee, J. (2022). Global anticoagulant market analysis. Pharmaceutical Market Reports, 27(1), 34–44.

[2] European Medicines Agency. (2013). ELIQUIS (Apixaban) approval summary.

[3] U.S. Food and Drug Administration. (2012). Approval letter for ELIQUIS.

[4] IQVIA. (2023). Global prescription drug market data.

[5] Bristol-Myers Squibb. (2022). Annual financial report.