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Last Updated: July 29, 2025

Apixaban - Generic Drug Details


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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, Indoco, Macleods Pharms Ltd, Micro Labs, Mylan, 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-two patent family members in forty-three countries.

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

Drug Sales Revenue Trends for apixaban

See drug sales revenues for apixaban

Recent Clinical Trials for apixaban

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

SponsorPhase
Centre Hospitalier Universitaire VaudoisPhase 2
Imperial College LondonPhase 4
Janssen Research & Development, LLCPhase 3

See all apixaban clinical trials

Generic filers with tentative approvals for APIXABAN
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free5MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free2.GMGTABLET;ORAL
⤷  Try for Free⤷  Try for Free5MGTABLET; 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 ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 AB RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Bristol Myers Squibb ELIQUIS apixaban TABLET, FOR SUSPENSION;ORAL 202155-003 Apr 17, 2025 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Bristol Myers Squibb ELIQUIS apixaban TABLET, FOR SUSPENSION;ORAL 202155-003 Apr 17, 2025 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aurobindo Pharma Ltd APIXABAN apixaban TABLET;ORAL 210026-002 May 26, 2023 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mylan APIXABAN apixaban TABLET;ORAL 210128-001 Dec 23, 2019 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol ELIQUIS SPRINKLE apixaban FOR SUSPENSION;ORAL 220073-001 Apr 17, 2025 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for apixaban

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 ⤷  Try for Free ⤷  Try for Free
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 2 of 2 entries

EU/EMA Drug Approvals for apixaban

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Bristol-Myers Squibb / Pfizer EEIG Eliquis apixaban EMEA/H/C/002148
For 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/005358
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).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
Showing 1 to 2 of 2 entries

International Patents for apixaban

CountryPatent NumberTitleEstimated Expiration
Denmark 3781132 ⤷  Try for Free
Hungary E043932 ⤷  Try for Free
Hungary S1300014 ⤷  Try for Free
Japan 6577980 ⤷  Try for Free
Slovenia 3251660 ⤷  Try for Free
South Korea 20210124532 아픽사반 제제 (APIXABAN FORMULATIONS) ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for apixaban

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1427415 115 5011-2011 Slovakia ⤷  Try for Free OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH
1427415 1190029-7 Sweden ⤷  Try for Free PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415 122011100050 Germany ⤷  Try for Free PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415 2011/032 Ireland ⤷  Try for Free PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415 C20110017 00045 Estonia ⤷  Try for Free PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
1427415 PA2011012,C1427415 Lithuania ⤷  Try for Free PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory for Apixaban

Last updated: July 27, 2025


Introduction

Apixaban, marketed under the brand name Eliquis by Pfizer and Bristol-Myers Squibb, is an oral anticoagulant used primarily to prevent and treat thromboembolic events. Since its FDA approval in 2012, apixaban’s market presence has expanded significantly, reflecting evolving therapeutic needs, competitive landscape, and regulatory developments. Analyzing its market dynamics and financial trajectory provides crucial insights for stakeholders evaluating future growth prospects.


Market Landscape and Therapeutic Positioning

Apixaban operates within the novel oral anticoagulant (NOAC) segment, which has transformed anticoagulation management by offering alternatives to warfarin. Its primary indications include stroke prevention in non-valvular atrial fibrillation (NVAF), treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and prophylaxis of venous thromboembolism (VTE).

The NOAC market has grown rapidly, driven by advantages such as fixed dosing, fewer dietary restrictions, and decreased need for routine monitoring. Apixaban’s favorable safety profile, particularly a lower risk of intracranial hemorrhage compared to warfarin, has bolstered its market adoption [1].


Market Drivers

1. Aging Population and Rising Incidence of Cardiovascular Disease

The global increase in older populations and the prevalence of atrial fibrillation have propelled demand for effective anticoagulants. The WHO estimates that AF affects approximately 37.5 million globally, with incidence expected to rise [2].

2. Clinical Evidence Supporting Superior Safety Profile

Multiple studies, including the ARISTOTLE trial, demonstrated apixaban’s superiority over warfarin in reducing stroke risk and hemorrhagic events, leading to its preferential use in clinical practice [3].

3. Regulatory Endorsements and Expanding Labeling

Regulatory agencies have expanded apixaban’s approved indications, encouraging off-label use where appropriate. Ongoing trials exploring expanded indications—such as prophylaxis in orthopedic surgeries—may further bolster its market.

4. Competitive Dynamics within NOACs

Apixaban faces competition from rivaroxaban (Xarelto), dabigatran (Pradaxa), and edoxaban (Savaysa). Its competitive edge derives from its safety and efficacy profile, as well as strategic marketing alliances and reimbursement policies.


Market Challenges

1. Patent Expiry and Generic Competition

Though apixaban’s primary patents are set to expire or have expired in key markets (e.g., the US in 2026), biosimilar and generic versions could erode margins. Patent challenges and patent term extensions influence timing of generic entry.

2. Cost and Reimbursement

While NOACs reduce monitoring costs, their higher drug prices compared to warfarin pose reimbursement hurdles in some healthcare systems. Pricing strategies and patient access initiatives impact market penetration.

3. Physician and Patient Preferences

Physician familiarity with established therapies like warfarin and dabigatran can slow adoption. Patient adherence, influenced by side effect profiles and convenience, also affects market dynamics.


Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

Since launch, apixaban has demonstrated robust revenue growth. In 2021, Eliquis generated approximately $8.3 billion globally, representing a significant portion of Pfizer and Bristol-Myers Squibb’s cardiology portfolio [4].

Factors Supporting Revenue Growth

  • Market Penetration: High adoption rates across North America, Europe, and emerging markets.
  • Expanding Indications: Approval for additional uses like prophylaxis post-knee or hip replacement.
  • Pricing and Reimbursement: Tiered pricing strategies in different regions influence gross revenues.

Forecasts for the Next 5 Years

Substantial growth prospects are projected, driven by:

  • Expanded Indications: Anticipated approvals for prophylaxis in surgical settings.
  • Increasing Demographics: Aging populations in North America, Europe, and Asia.
  • Market Share Gains: Continued clinical preference for apixaban over competitors.

Analysts project apixaban’s revenues to reach approximately $12–15 billion globally by 2028, assuming patent protections and favorable market conditions persist [5].

Impact of Patent Expiration

Patent expiry timelines suggest potential generic entry into major markets by 2026–2027. While initial revenue erosion is expected, strategic patent litigations, formulation patents, and market exclusivities may prolong brand dominance.


Strategic Opportunities and Risks

Opportunities

  • Line Extensions and Fixed-Dose Combinations: Developing combination therapies with antiplatelet agents, statins, or other cardiovascular drugs.
  • Emerging Markets: Expanding access in Asia-Pacific and Latin America presents high-growth opportunities.
  • Digital Health Integration: Leveraging digital compliance tools enhances adherence and therapeutic outcomes.

Risks

  • Regulatory Hurdles: Delays or rejections for new indications could impede growth.
  • Pricing Pressures: Governments’ push for cost containment may limit pricing flexibility.
  • Competitive Shifts: Advances in alternatives (e.g., gene therapies) could disrupt the anticoagulant market landscape.

Conclusion

Apixaban’s market dynamics are characterized by strong clinical positioning, demographic-driven demand, and competitive pressures. Its financial trajectory remains favorable in the near to medium term, bolstered by expanding indications and geographical reach. However, patent expiry and evolving competition warrant strategic vigilance. Companies supporting apixaban should prioritize innovation, pricing strategies, and market expansion to sustain and enhance revenue streams.


Key Takeaways

  • Strong Growth Drivers: Aging demographics, stroke prevention needs, and favorable safety profile underpin apixaban’s market expansion.
  • Market Competition: Rivals and biosimilars pose long-term challenges; differentiation relies on efficacy, safety, and strategic patent management.
  • Revenue Projections: Anticipated to grow to US$12–15 billion globally by 2028, barring significant patent expirations or regulatory obstacles.
  • Strategic Levers: Expansion into new indications, geographic markets, and combination therapies present opportunities for sustained revenue.
  • Market Risks: Patent expiries, reimbursement constraints, and competitive innovations necessitate continuous adaptation.

FAQs

1. When is apixaban’s major patent expiration, and how might it impact revenues?
Major patents in the US are expected to expire around 2026–2027, opening pathways for biosimilar competition that could significantly reduce branded sales unless extended through formulation or patent strategies.

2. How does apixaban compare to other NOACs regarding market share prevalence?
Apixaban has gained a leading position due to superior safety and efficacy in key trials, often surpassing rivaroxaban and dabigatran, especially in stroke prevention for atrial fibrillation.

3. What regulatory developments could influence apixaban’s market?
Potential approvals for new indications such as post-surgical prophylaxis or in other thromboembolic conditions could expand its addressable market, contingent on positive clinical trial outcomes and regulatory support.

4. In which regions does apixaban see the fastest growth?
Emerging markets in Asia and Latin America are experiencing rapid adoption owing to increasing cardiovascular disease burden and evolving healthcare infrastructure.

5. What strategies can preserve apixaban’s market dominance amid patent expiry?
Enhancing formulation patents, developing combination products, expanding indications, and entering new markets will be essential to mitigate generic erosion.


References

[1] Efird, J.T. et al. (2019). "A Review of Apixaban: Efficacy and Safety Data in Atrial Fibrillation." Clinical Cardiology.
[2] World Health Organization. (2020). "Atrial Fibrillation Fact Sheet."
[3] Granger, C.B. et al. (2011). "Apixaban versus Warfarin in Patients with Atrial Fibrillation." N Engl J Med.
[4] Pfizer Inc. (2022). "Eliquis Global Sales Report."
[5] Market Research Future. (2022). "Global Apixaban Market Analysis and Forecast."

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