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Last Updated: April 5, 2026

apixaban - Profile


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What are the generic drug sources for apixaban and what is the scope of freedom to operate?

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 ten tentative approvals for this compound.

Summary for apixaban
International Patents:196
US Patents:3
Tradenames:3
Applicants:15
NDAs:15
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for apixaban
Generic filers with tentative approvals for APIXABAN
Applicant Application No. Strength Dosage Form
⤷  Start Trial⤷  Start Trial5MGTABLET;ORAL
⤷  Start Trial⤷  Start Trial2.GMGTABLET;ORAL
⤷  Start Trial⤷  Start Trial5MGTABLET; ORAL

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

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
Bristol ELIQUIS SPRINKLE apixaban FOR SUSPENSION;ORAL 220073-001 Apr 17, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bristol ELIQUIS SPRINKLE apixaban FOR SUSPENSION;ORAL 220073-001 Apr 17, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bristol ELIQUIS SPRINKLE apixaban FOR SUSPENSION;ORAL 220073-001 Apr 17, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for apixaban

Country Patent Number Title Estimated Expiration
Australia 2008207537 ⤷  Start Trial
China 104744461 ⤷  Start Trial
Japan 2009079059 LACTAM-CONTAINING COMPOUND AND DERIVATIVE THEREOF AS FACTOR Xa INHIBITOR ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for apixaban

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1427415 91888 Luxembourg ⤷  Start Trial 91888, EXPIRES: 20260518
1427415 122011100050 Germany ⤷  Start Trial PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415 C20110017 00045 Estonia ⤷  Start Trial PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Investment Scenario and Fundamentals Analysis for Apixaban

Last updated: February 20, 2026

What is Apixaban and Why Is It Relevant for Investment?

Apixaban is an oral anticoagulant developed by Bristol-Myers Squibb and Pfizer. It is marketed under the brand name Eliquis. Approved by the US Food and Drug Administration (FDA) in 2012, apixaban is used to prevent blood clots in atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE), and for postoperative thromboprophylaxis.

The drug competes in a highly lucrative market, estimated globally at around $8 billion in 2022, with projected compound annual growth rate (CAGR) of 6% through 2030. It faces competition from rivaroxaban, dabigatran, and warfarin but maintains a strong market position due to its efficacy and safety profile.

What are the Market Dynamics and Competitive Position of Apixaban?

Market Overview

Parameter Data
2022 Global Market Size $8 billion
Major Markets US, EU, China, Japan
Target Indications Atrial fibrillation, DVT, PE, postoperative prophylaxis
CAGR (2023-2030) 6%

Competitive Landscape

Key Drugs Market Share (Est. 2022) Development Stage Notes
Apixaban (Eliquis) 38% Mature Leading in atrial fibrillation and DVT/PE indications
Rivaroxaban 30% Mature Strong second-place, similar indications
Dabigatran 12% Mature Approved primarily for stroke prevention in AFib
Warfarin 15% Generic Limited by necessity of monitoring and dietary restrictions

Key Drivers for Investment

  • Demonstrated superior safety profile compared to competitors, especially regarding bleeding risks.
  • Expanding indication approvals, including extended use in reduction of risk post-orthopedic surgery.
  • Growing prevalence of atrial fibrillation and venous thromboembolism globally.
  • Increased adoption by healthcare providers in emerging markets.

How Do the Fundamentals Look for Apixaban?

Patent and Regulatory Data

  • Patent expiry for Eliquis is projected for 2030 in the US and EU, after extensions.
  • Regulatory approvals span over 100 countries, with recent extensions for stroke prevention in patients with moderate renal impairment.

Revenue and Sales Trends

Year Sales (USD millions) Year-over-Year Growth (%)
2020 4,200 10%
2021 4,620 10%
2022 5,100 10.4%
  • Consistent double-digit growth driven by expanding indications and geographic market expansion.
  • Key markets include the US (~$2.7 billion), Europe (~$1.7 billion), China (~$400 million).

Cost and Margins

  • Manufacturing cost per unit is between $50 and $70, with a gross margin exceeding 85% due to high drug pricing.
  • R&D expenses estimated at 10-15% of sales, primarily for new indications and biosimilar competition monitoring.

Financials of Bristol-Myers Squibb (BMS) and Pfizer

Company Revenue from Eliquis (USD millions) R&D Investment (USD millions) Operating Margin (%)
BMS 60% of oncology and CV franchise 4,500 (2022) 33%
Pfizer 75% of CV drug portfolio 1,200 (2022) 29%

Patent Landscape and Biosimilar Threat

  • Patent protection until 2030 provides market exclusivity.
  • Biosimilar competition is unlikely given the complex nature of apixaban's manufacturing and existing patent extensions.

What Are the Risks and Opportunities?

Risks

  • Patent cliff after 2030 could lead to revenue erosion unless new indications are approved.
  • Competition from biosimilars or generics may reduce pricing power.
  • Regulatory delays or restrictions in emerging markets could limit growth.
  • Potential safety concerns could impact regulatory approval or market perception.

Opportunities

  • Approval expansion for additional indications, especially in thromboprophylaxis post-orthopedic surgery.
  • Increasing shift toward oral anticoagulants over warfarin globally.
  • Growth in emerging markets driven by aging populations and increasing cardiovascular disease prevalence.
  • Potential for partnership or licensing deals in unpenetrated regions.

What Is the Investment Outlook?

  • Apixaban remains a core asset for BMS and Pfizer due to its leading market position and robust revenue growth.
  • Revenue is likely to grow at a CAGR of 5-8% through 2025, driven by ongoing market penetration.
  • The expiration of patents in 2030 raises risks of revenue decline unless new indications or formulations are approved.
  • Stock valuation reflects a premium for strong market share, stable cash flows, and growth potential.

Key Takeaways

  • Apixaban is a leading oral anticoagulant with stable revenue streams and expanding indications.
  • Market growth is supported by aging populations and the shift from warfarin to direct oral anticoagulants.
  • Patent expiry in 2030 presents a risk for revenue decline, contingent on pipeline success.
  • Competition from biosimilars remains low due to manufacturing complexity and patent protections.
  • Investment hinges on continued market expansion, regulatory approvals, and pipeline development.

FAQs

1. How long will apixaban remain profitable given patent expiry?
Patents expire around 2030 in major markets, but revenue may persist if new indications or formulations are approved and biosimilar competition remains limited.

2. What are the main competitors to apixaban?
Rivaroxaban, dabigatran, and warfarin are primary competitors, with rivaroxaban closest in market share.

3. Are there any recent regulatory issues affecting apixaban?
No significant recent regulatory restrictions; approvals continue to expand, including in emerging markets.

4. What emerging markets offer growth opportunities for apixaban?
China, India, and Southeast Asian countries present expanding markets due to increasing cardiovascular disease prevalence.

5. How do manufacturing costs impact margins?
Manufacturing costs are relatively low ($50–$70 per unit), maintaining gross margins above 85%, supporting pricing power.


References

[1] IQVIA. (2022). Global Market Report: Anticoagulants. [2] Bristol-Myers Squibb. (2023). Annual Report. [3] Pfizer. (2023). Annual Report. [4] U.S. Food and Drug Administration. (2012). Approval for Eliquis.

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