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. Ten 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:	10
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	246
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
University of Melbourne	PHASE4
Emily McDonald	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
		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
Torrent	APIXABAN	apixaban	TABLET;ORAL	210156-001	Dec 17, 2024		DISCN	No	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155-003	Apr 17, 2025		RX	Yes	Yes
Hetero Labs Ltd V	APIXABAN	apixaban	TABLET;ORAL	210066-002	Nov 21, 2023		DISCN	No	No
Aurobindo Pharma Ltd	APIXABAN	apixaban	TABLET;ORAL	210026-001	May 26, 2023		DISCN	No	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No
Bristol	ELIQUIS SPRINKLE	apixaban	FOR SUSPENSION;ORAL	220073-001	Apr 17, 2025		RX	Yes	Yes	6,967,208*PED				Y

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
Peru	20130378	FORMULACIONES DE APIXABAN
Hungary	E047139
Russian Federation	2004112191
Norway	20083684
Portugal	1427415
Japan	2016065086	アピキサバン製剤 (APIXABAN FORMULATION)

Supplementary Protection Certificates for apixaban

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	443	Finland
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	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	1190029-7	Sweden		PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415	31/2011	Austria		PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520

Market Dynamics and Financial Trajectory for APIXABAN

Last updated: January 21, 2026

Summary

APIXABAN (brand names: Eliquis, Apixaban) is an oral anticoagulant used primarily for stroke prevention in atrial fibrillation (AF), deep vein thrombosis (DVT), and pulmonary embolism (PE). Since its FDA approval in 2012, APIXABAN has experienced rapid market growth driven by increasing prevalence of cardiovascular disorders, competitive positioning against warfarin and other direct oral anticoagulants (DOACs), and evolving regulatory pathways. This report analyses the current market landscape, forecasted financial trajectory, key competitive factors, regulatory influences, and strategic considerations for stakeholders.

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What Are the Market Drivers for APIXABAN?

Prevalence of Indications

Indication	2023 Prevalence Estimates	Forecast 2030	Source
Non-valvular atrial fibrillation (NVAF)	37 million globally	45 million	[1]
Venous thromboembolism (VTE)	3 million annually (US/Europe)	4.5 million	[2]
Mechanical heart valves (specific)	1 million	Stable but niche	[3]

Key Market Drivers

Element	Impact	Explanation
Aging Population	High	Global elderly population increasing incidence of AF and VTE
Shift from VKAs to DOACs	High	Preference for predictable pharmacokinetics, reduced monitoring, safety profile
Clinical Guidelines	Positive	Recommendations favoring DOACs over warfarin (CPGs by ESC, AHA)
Patent Expiry & Generics	Moderate to High	Patent expiry timelines influence pricing and market share

Competitive Landscape

Competitors	Market Share (2023)	Key Differentiators	Notes
Apixaban (Eliquis)	48%	Favorable bleeding profile, extensive clinical data	Dominant in US & developed markets
Rivaroxaban (Xarelto)	36%	Once-daily dosing	Competitive across indications
Dabigatran (Pradaxa)	10%	First-in-class DTI	Declining in favor due to bleeding risk
Edoxaban (Lixiana)	6%	Limited availability	Niche market

(Data sources: IQVIA, EvaluatePharma, 2023)

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How Has APIXABAN’s Financial Trajectory Evolved?

Revenue Generation and Growth Patterns

Year	Global Sales (USD Million)	Growth Rate	Remarks
2014	1,200	—	Initial launch in US & Europe
2018	5,800	30% CAGR	US market expansion completed
2022	9,500	11% YoY	Growth plateau in mature markets
2023	10,300	+8.4%	Emerging markets, new indications

Market Penetration and Revenue Distribution

Region	2023 Revenue (USD Million)	% of Total	Key Factors
North America	5,200	50%	Largest market, high prescribing rates
Europe	3,100	30%	Well-established, reimbursement policies
Asia-Pacific	1,500	15%	Growing adoption, demographic shifts
Rest of World	500	5%	Emerging, regulatory barriers

Pricing Strategies and Economic Factors

Factor	Impact	Notes
Patent Protection	Positive	Patent expiry in 2026 (US) and 2025 (EU) threatens revenue
Pricing Pressure	High	Generics expected post-patent expiration create downward pressure
Reimbursement Policies	Variable	Favorable in developed markets; limited access in emerging regions

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What Are the Regulatory and Patent Outlooks?

Patent Expiry Timelines

Jurisdiction	Expiry Year	Notes
US	2026	Patent cliff approaches
EU	2025	Imminent generic market entry
Key Asia-Pacific Countries	2027-2028	Variations, dependent on local patent laws

Impact of Patent Expiry

• Predicted decline of up to 60-70% in US sales within 2-3 years of patent expiry due to generics (based on historical data for biosimilar launches)
• Increased price competition
• Potential revenue shift to biosimilar suppliers or alternative anticoagulants

Regulatory Policies Influencing Market Access

Policy Area	Effect	Notable Notes
Price Control Regulations	Lower pricing	Countries like India, Canada
Reimbursement Policies	Affect market penetration	CMS, NICE guidelines
Approval of Biosimilars	Competition increase	Expect influx of generics post-patent expiry

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Comparison with Other DOACs and Treatment Options

Aspect	Apixaban	Rivaroxaban	Dabigatran	Warfarin	Edoxaban
Dosing Frequency	BID	QD	BID	Variable	QD
Bleeding Risk	Lower	Moderate	Higher	Higher	Similar to Apixaban
Clinical Evidence	Extensive	Extensive	Moderate	Extensive	Growing
Patent Status (2023)	Valid until 2026	Valid until 2024	Expired	N/A	Valid until 2028 in some regions

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Future Market and Financial Forecasts

Projected Revenue Growth

Scenario	CAGR (2023-2030)	Remarks
Optimistic	9-12%	Accelerated adoption in emerging markets, new indications
Moderate	6-8%	Maturation in major markets, patent expiry impact
Pessimistic	3-5%	Increased generic competition, regulatory hurdles

Key Factors Influencing Future Revenue

Factor	Potential Effect	Mitigating Strategies
Additional Indications	Revenue expansion	Rivaroxaban’s off-label uses
Biosimilar Competition	Revenue erosion	Patent extension challenges, novel formulations
Market Expansion	Growth	Entering new geographies, especially Asia-Pacific

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Deep Dive: Strategic Considerations for Stakeholders

Stakeholder	Key Considerations	Strategic Actions
Pharma Developers	Patent expiration, biosimilars	R&D pipelines, new formulations, combination therapies
Investors	Revenue stability post-patent expiry	Diversification, focus on emerging markets
Regulators	Safety, access	Streamline approval processes, price controls
Payers	Cost containment	Formularies favoring generics, negotiated pricing

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Comparison of APIXABAN Market Trajectory with Similar Pharmaceuticals

Metric	APIXABAN	Rivaroxaban	Dabigatran	Edoxaban
Launch Year	2012	2008	2010	2015
2023 Global Sales (USD Millions)	10,300	9,000	1,500	900
Patent Expiry (US)	2026	2024	2022	2028
CAGR (2014-2022)	24%	22%	20%	18%

(Sources: IQVIA, Evaluate Pharma, 2023)

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FAQs

Q1: What are the main factors driving APIXABAN’s market growth?
A1: The main factors include the rising prevalence of atrial fibrillation and VTE, the shift towards DOACs over warfarin due to safety and convenience, evolving clinical guidelines favoring DOACs, and expanding access in emerging markets.

Q2: How will patent expiration impact APIXABAN’s revenue?
A2: Patent expiry, expected in 2025-2026 in key markets, is projected to lead to increased generic competition, potentially reducing revenue by 60-70% within two years post-expiration, unless new formulations or indications are introduced.

Q3: How does APIXABAN compare to other DOACs in terms of market share?
A3: As of 2023, APIXABAN captures approximately 48% of the DOAC market, leading Rivaroxaban at 36%. Its favorable bleeding profile and extensive clinical data support its market position.

Q4: What are the emerging opportunities and challenges for APIXABAN?
A4: Opportunities include expanding indications, entering new geographical markets, and biosimilar competition. Challenges encompass patent cliffs, pricing pressures, and regulatory hurdles.

Q5: Which regions present the highest growth potential for APIXABAN?
A5: Asia-Pacific and Latin America exhibit significant growth potential due to rising cardiovascular disease burden and improving healthcare infrastructure, despite regulatory challenges.

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Key Takeaways

• Market Expansion: APIXABAN remains a leading DOAC with over USD 10 billion in global sales in 2023, driven by existing indications and new market entries.
• Patent Expiry Risks: Patent protection slated to expire from 2025-2026 poses significant revenue risks; strategic R&D investments are vital.
• Competitive Environment: The market is mature, with Rivaroxaban as the primary competitor; emerging generic options will influence pricing and adoption.
• Growth Opportunities: Additional indications, biosimilar entry, and expansion into emerging markets offer potential growth avenues.
• Regulatory and Pricing Strategies: Navigating diverse regulatory requirements and payer policies will be critical for sustained market share.

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References

[1] Global Burden of Disease Study, 2023
[2] European Society of Cardiology, 2022 Guidelines for Atrial Fibrillation
[3] Evaluate Pharma, 2023
[4] IQVIA, 2023
[5] U.S. Food and Drug Administration, 2012 & 2023 Patent Data