APIXABAN Drug Patent Profile

When do Apixaban patents expire, and when can generic versions of Apixaban launch?

Apixaban is a drug marketed by 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 thirteen NDAs.

The generic ingredient in APIXABAN 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 Apixaban

A generic version of APIXABAN was approved as apixaban by ACCORD HLTHCARE on July 28^th, 2020.

Summary for APIXABAN

US Patents:	0
Applicants:	13
NDAs:	13
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	247
Patent Applications:	4,127
Drug Sales Revenues:	Drug sales revenues for APIXABAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APIXABAN
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

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
Accord Hlthcare	APIXABAN	apixaban	TABLET;ORAL	210180-001	Jul 28, 2020	AB	RX	No	No
Micro Labs	APIXABAN	apixaban	TABLET;ORAL	210013-002	Dec 23, 2019		DISCN	No	No
Torrent	APIXABAN	apixaban	TABLET;ORAL	210156-002	Dec 17, 2024		DISCN	No	No
Bionpharma	APIXABAN	apixaban	TABLET;ORAL	210152-001	Apr 8, 2020		DISCN	No	No

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

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.

---

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.