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Last Updated: May 27, 2024

APIXABAN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Apixaban

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

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Drug patent expirations by year for APIXABAN
Drug Sales Revenue Trends for APIXABAN

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Recent Clinical Trials for APIXABAN

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

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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

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan APIXABAN apixaban TABLET;ORAL 210128-002 Dec 23, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bionpharma APIXABAN apixaban TABLET;ORAL 210152-001 Apr 8, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex APIXABAN apixaban TABLET;ORAL 210091-002 Feb 16, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V APIXABAN apixaban TABLET;ORAL 210066-002 Nov 21, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms APIXABAN apixaban TABLET;ORAL 210185-002 Feb 27, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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/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

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