➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Baxter
Boehringer Ingelheim
AstraZeneca
McKinsey

Last Updated: April 12, 2021

DrugPatentWatch Database Preview

APIXABAN - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic 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
Cambridge University Hospitals NHS Foundation Trust (joint Sponsor)Phase 3

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
Micro Labs APIXABAN apixaban TABLET;ORAL 210013-001 Dec 23, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Micro Labs APIXABAN apixaban TABLET;ORAL 210013-002 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 2011/032 Ireland   Start Trial PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415 31/2011 Austria   Start Trial PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520
1427415 11C0042 France   Start Trial PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
McKinsey
Boehringer Ingelheim
Moodys
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.