APIXABAN - Generic Drug Details

What are the generic drug 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. Eleven suppliers are listed for this compound. There are nine 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:	11
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	243
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
Emily McDonald	PHASE4
University of Melbourne	PHASE4

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
		2.5MG	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
Aurobindo Pharma Ltd	APIXABAN	apixaban	TABLET;ORAL	210026-001	May 26, 2023		DISCN	No	No
Bionpharma	APIXABAN	apixaban	TABLET;ORAL	210152-001	Apr 8, 2020		DISCN	No	No
Macleods Pharms Ltd	APIXABAN	apixaban	TABLET;ORAL	210067-002	Feb 27, 2025		DISCN	No	No
Apotex	APIXABAN	apixaban	TABLET;ORAL	210091-001	Feb 16, 2024		DISCN	No	No
Micro Labs	APIXABAN	apixaban	TABLET;ORAL	210013-002	Dec 23, 2019		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	202155-002	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 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
Hungary	0402463
Croatia	P20040280	SPOJEVI KOJI SADRŽE LAKTAM I NJIHOVI DERIVATI KAO INHIBITORI FAKTORA Xa (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR Xa INHIBITORS)
Croatia	P20190430
Colombia	6640207	Formulaciones de apixaban
Hungary	E067789

Supplementary Protection Certificates for APIXABAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	443	Finland
1427415	2011C/034	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
1427415	C01427415/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
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

Market Dynamics and Financial Trajectory for Apixaban

Last updated: November 18, 2025

Introduction

Apixaban, marketed primarily under the brand name Eliquis, is an oral anticoagulant introduced by Bristol-Myers Squibb and Pfizer. As a direct Factor Xa inhibitor, it plays a vital role in preventing and treating thromboembolic disorders. Since its FDA approval in 2012, Apixaban has experienced significant market penetration, driven by evolving clinical guidelines, competitive landscape shifts, and pharmacoeconomic factors. This analysis details its current market dynamics and forecasts its financial trajectory, providing critical insights for stakeholders.

Pharmacological Profile and Clinical Positioning

Apixaban’s mechanism of action involves selective inhibition of Factor Xa, reducing thrombin generation, and subsequently thrombus formation. Its differentiated profile—with oral administration, fewer dietary interactions, and lower bleeding risk—has established it as a preferred alternative to warfarin and other anticoagulants (e.g., rivaroxaban, dabigatran). Clinical trials such as ARISTOTLE solidified its efficacy in atrial fibrillation-related stroke prevention, deepening its clinical foothold [1].

Market Size and Growth Drivers

Global Anticoagulant Market Landscape

The global anticoagulant market, estimated at approximately USD 9 billion in 2022, is projected to reach USD 17.5 billion by 2030, growing at a CAGR of about 8% (2023-2030). This expansion is driven by rising prevalence of atrial fibrillation (AF), venous thromboembolism (VTE), and an aging global population. AF alone affects over 37 million individuals worldwide [2].

Key Growth Drivers

1. Epidemiological Trends: Increased aging populations elevate the incidence of AF and VTE, creating sustained demand for anticoagulants.
2. Clinical Guidelines Revisions: Recommendations favor NOACs (including Apixaban) over warfarin for non-valvular AF and VTE, emphasizing superior safety profiles and convenience [3].
3. Regulatory Approvals and Off-Label Uses: Approvals for additional indications such as prophylaxis post-orthopedic surgery have expanded the market.
4. Urbanization and Lifestyle Changes: Lifestyle-induced risk factors (obesity, hypertension) intensify thrombotic conditions.

Competitive Environment

The anticoagulant market is fiercely competitive, with key players including Bristol-Myers Squibb/Pfizer (Apixaban), Bayer (rivaroxaban), Boehringer Ingelheim (dabigatran), and generics providers. Rivaroxaban (Xarelto) is its primary competitor, often vying for market share based on efficacy, safety, and formulary preferences.

Market Dynamics Influencing Financial Trajectory

Regulatory and Patent Landscape

Bristol-Myers Squibb and Pfizer hold patent exclusivity for Eliquis until approximately 2026–2028 in key territories. Patent expiries enable generic entrants, pressuring prices and margins. However, patent rights, regulatory exclusivities, and formulations delay generic penetration in highly regulated markets, supporting revenue stability.

Pricing and Reimbursement Policies

Healthcare systems worldwide favor cost-effective therapies. Apixaban’s clinical advantages translate into favorable reimbursement, but pricing pressures persist, especially from generics. In the U.S., Medicare and Medicaid negotiations influence net pricing strategies.

Adoption in Emerging Markets

Growing healthcare infrastructure and increased awareness promote Apixaban’s adoption in emerging economies. Pricing and supply chain logistics are crucial factors influencing market entry and expansion in these regions.

Partnerships and Licensing

Strategic collaborations, licensing agreements, and co-marketing initiatives further accelerate market penetration, particularly in regions with limited local manufacturing.

Financial Trajectory and Future Outlook

Revenue Growth Projections

Analyzing historical sales data, Apixaban generated approximately USD 5.4 billion globally in 2022. Market analysts project a compound annual growth rate (CAGR) of around 8–10% through 2030, driven by:

• Increased adoption in new indications such as secondary VTE prevention.
• Rising prevalence of AF and age-related thrombotic conditions.
• Expansion into emerging markets.

Assuming these growth parameters, revenues may reach USD 11–12 billion by 2030, factoring in patent expiries and generic competition.

Impact of Patent Expiry

The patent expiry slated post-2026 could trigger biosimilar and generic entrants, resulting in price erosion of 40–60%. While this may reduce profit margins, volume increases and expanded indications can offset declining per-unit revenues, preserving high overall sales.

Research and Development Opportunities

Novel formulations (e.g., fixed-dose combinations, injectable variants) and additional indications (e.g., deep vein thrombosis, pulmonary embolism in pediatric populations) represent avenues for revenue expansion.

Competitive and Regulatory Risks

The emergence of new anticoagulants, reversal agents (e.g., Andexanet alfa approved for FXa inhibitor reversal), or adverse regulatory decisions could impact market share and revenue streams.

Strategic Recommendations

• Focus on expanding indications and geographic markets, especially in emerging economies.
• Invest in patient adherence programs, leveraging the convenience of oral administration.
• Monitor biosimilar developments and prepare for price competition post-patent expiry.
• Engage proactively with regulatory authorities for timely approvals and label extensions.
• Strengthen reimbursement relationships with healthcare payers.

Key Takeaways

• Market Growth: Apixaban is positioned within a rapidly expanding anticoagulant market driven by demographic shifts and evolving clinical guidelines.
• Revenue Potential: With consistent CAGR projections of about 8–10%, revenues could reach USD 11–12 billion by 2030, despite patent expiries.
• Competitive Edge: Its safety profile and broad clinical validation sustain market dominance, although impending patent expiries necessitate strategic adaptations.
• Emerging Market Opportunities: Growth prospects in emerging economies can boost volume, offsetting price erosion.
• Innovation & Expansion: R&D investments into new formulations and indications can further enhance Apixaban’s financial trajectory.

Conclusion

Apixaban’s market dynamics reflect a combination of strong clinical positioning, demographic-driven demand, and competitive challenges. While patent protection offers lucrative revenues in the near term, market entrants and price pressures necessitate strategic innovations. Stakeholders should prioritize geographic expansion, indication diversification, and cost management to capitalize on the drug’s robust growth trajectory.

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FAQs

1. How will patent expiration affect Apixaban’s market share?
Patent expiry post-2026 will open the market to biosimilars and generics, likely causing substantial price reductions and erosion of profit margins. However, increased volume and new indications can mitigate revenue loss.

2. What are the key differentiators of Apixaban compared to rivals like rivaroxaban?
Apixaban’s lower bleeding risk, proven stroke prevention efficacy, and flexible dosing regimens serve as competitive advantages, reinforcing its preference in clinical practice.

3. Which emerging markets show the highest growth potential for Apixaban?
Regions such as Asia-Pacific, Latin America, and Eastern Europe are poised for rapid growth due to expanding healthcare infrastructure and rising disease prevalence.

4. Are there new indications for Apixaban under clinical investigation?
Yes, ongoing research explores its use in conditions like deep vein thrombosis, pulmonary embolism in pediatric populations, and secondary prevention of cardiovascular events.

5. What role do regulatory approvals play in Apixaban’s future financial performance?
Timely approval for new indications or formulations, along with maintenance of exclusivity, directly influences sales growth and market share retention.

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Sources:
[1] ARISTOTLE Trial, 2011. New England Journal of Medicine.
[2] World Health Organization, 2021. Global Prevalence of Atrial Fibrillation.
[3] American College of Cardiology Guidelines, 2020.