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Last Updated: March 3, 2021

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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, Indoco, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in six 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-six patent family members in forty-two countries.

There are thirty drug master file entries for apixaban. Seven suppliers are listed for this compound. There are four 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
Dt&SanomedicsPhase 2
Korea University Guro HospitalPhase 2
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) NetworkPhase 4

See all apixaban clinical trials

Generic filers with tentative approvals for APIXABAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MGTABLET; ORAL
  Start Trial  Start Trial2.5MGTABLET; 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.

Pharmacology for apixaban
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Paragraph IV (Patent) Challenges for APIXABAN
Tradename Dosage Ingredient NDA Submissiondate
ELIQUIS TABLET;ORAL apixaban 202155 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   Start Trial   Start Trial Y Y   Start Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Bionpharma Inc APIXABAN apixaban TABLET;ORAL 210152-001 Apr 8, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare APIXABAN apixaban TABLET;ORAL 210180-001 Jul 28, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Micro Labs APIXABAN apixaban TABLET;ORAL 210013-001 Dec 23, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Indoco APIXABAN apixaban TABLET;ORAL 209898-001 Sep 11, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan APIXABAN apixaban TABLET;ORAL 210128-001 Dec 23, 2019 DISCN No No   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

Supplementary Protection Certificates for apixaban

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1427415 C 2011 008 Romania   Start Trial 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 SPC/GB11/042 United Kingdom   Start Trial PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/11/691/001 20110520; UK EU/1/11/691/002 20110520; UK EU/1/11/691/003 20110520; UK EU/1/11/691/004 20110520; UK EU/1/11/691/005 20110520
1427415 CA 2011 00028 Denmark   Start Trial
1427415 C300500 Netherlands   Start Trial PRODUCT NAME: APIXABAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415 2011/032 Ireland   Start Trial PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415 1190029-7 Sweden   Start Trial PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415 115 5011-2011 Slovakia   Start Trial OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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