Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
McKesson
Johnson and Johnson
Julphar
Merck
Cipla
Covington
Federal Trade Commission
Teva
Chinese Patent Office

Generated: February 25, 2018

DrugPatentWatch Database Preview

Apixaban - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for apixaban and what is the scope of apixaban freedom to operate?

Apixaban
is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in one NDA. 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 thirty-seven patent family members in forty countries.

There are twenty-six drug master file entries for apixaban. Three suppliers are listed for this compound.
Pharmacology for apixaban
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors

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 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for apixaban

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,531,535 Lactam-containing compounds and derivatives thereof as factor Xa inhibitors ➤ Sign Up
8,470,854 Lactam-containing compounds and derivatives thereof as factor XA inhibitors ➤ Sign Up
6,673,810 Imidazo-heterobicycles as factor Xa inhibitors ➤ Sign Up
6,989,391 Lactam-containing compounds and derivatives thereof as factor Xa inhibitors ➤ Sign Up
7,371,761 Lactam-containing compounds and derivatives thereof as factor Xa inhibitors ➤ Sign Up
6,995,172 Lactam-containing compounds and derivatives thereof as factor Xa inhibitors ➤ Sign Up
7,960,411 Lactam-containing compounds and derivatives thereof as factor Xa inhibitors ➤ Sign Up
6,858,616 Nitrogen containing heterobicycles as factor Xa inhibitors ➤ Sign Up
7,338,963 Lactam-containing compounds and derivatives thereof as factor Xa inhibitors ➤ Sign Up
7,691,846 Lactam-containing compounds and derivatives thereof as factor Xa inhibitors ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for apixaban

Country Document Number Estimated Expiration
Hungary 228195 ➤ Sign Up
Serbia 20040227 ➤ Sign Up
China 100340559 ➤ Sign Up
Japan 2009079059 ➤ Sign Up
Malaysia 138239 ➤ Sign Up
Singapore 182750 ➤ Sign Up
Hungary E027168 ➤ Sign Up
Montenegro P58108 ➤ Sign Up
Hong Kong 1052508 ➤ Sign Up
South Africa 200103795 ➤ Sign Up
Country Document Number Estimated Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Supplementary Protection Certificates for apixaban

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1427415/01 Switzerland ➤ Sign Up FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
C0042 France ➤ Sign Up PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110518
C/GB11/042 United Kingdom ➤ Sign Up 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
3 Finland ➤ Sign Up
2011012 Lithuania ➤ Sign Up PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518
2011 00028 Denmark ➤ Sign Up
888 Luxembourg ➤ Sign Up 91888, EXPIRES: 20260518
5 5011-2011 Slovakia ➤ Sign Up FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
0110017 00045 Estonia ➤ Sign Up PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
11/032 Ireland ➤ Sign Up PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Citi
AstraZeneca
Mallinckrodt
US Department of Justice
Cerilliant
Baxter
McKesson
Argus Health

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 verifification 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.

botpot