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Last Updated: May 26, 2022

Apixaban - Generic Drug Details


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What are the generic drug sources for apixaban and what is the scope of patent protection?

Apixaban is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Bionpharma Inc, Breckenridge, Indoco, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in seven NDAs. There are two 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 sixty-eight patent family members in forty-two countries.

There are thirty drug master file entries for apixaban. Seven suppliers are listed 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
University Hospital, GenevaPhase 3
Sunnybrook Health Sciences CentrePhase 3
Laval UniversityPhase 2

See all apixaban clinical trials

Pharmacology for apixaban
Drug ClassFactor Xa Inhibitor
Mechanism of Action Factor 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
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bionpharma Inc APIXABAN apixaban TABLET;ORAL 210152-002 Apr 8, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for apixaban

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for apixaban

Country Patent Number Title Estimated Expiration
European Patent Office 1427415 COMPOSES CONTENANT DU LACTAME ET LEURS DERIVES EN TANT QU'INHIBITEURS DU FACTEUR XA (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS) See Plans and Pricing
Singapore 10201501349V APIXABAN FORMULATIONS See Plans and Pricing
China 104744461 See Plans and Pricing
>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 See Plans and Pricing 91888, EXPIRES: 20260518
1427415 C 2011 008 Romania See Plans and Pricing 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 31/2011 Austria See Plans and Pricing PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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