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Last Updated: January 20, 2020

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ELIQUIS Drug Profile

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Which patents cover Eliquis, and what generic alternatives are available?

Eliquis is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-five patent family members in forty-three countries.

The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the apixaban profile page.

US ANDA Litigation and Generic Entry Outlook for Eliquis

  Start Trial

Eliquis was eligible for patent challenges on December 28th, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 21st, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $4.4bn, indicating a strong incentive for generic entry.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (apixaban), which indicates the potential for near-term generic launch.

Drug patent expirations by year for ELIQUIS
Drug Prices for ELIQUIS

See drug prices for ELIQUIS

Drug Sales Revenue Trends for ELIQUIS

See drug sales revenues for ELIQUIS

Generic Entry Opportunity Date for ELIQUIS
Generic Entry Date for ELIQUIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ELIQUIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yale UniversityPhase 3
University of ZurichPhase 3
Mansoura UniversityPhase 1/Phase 2

See all ELIQUIS clinical trials

Recent Litigation for ELIQUIS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bristol-Myers Squibb Company v. Dr. Reddy's Laboratories, Ltd.2018-01-19
Bristol-Myers Squibb Company v. Prinston Pharmaceutical Inc.2017-04-13
Bristol-Myers Squibb Company v. Mylan Pharmaceuticals Inc.2017-04-12

See all ELIQUIS litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2018-04-05
Coalition for Affordable Drugs IX, LLC2015-08-13

See all ELIQUIS litigation

Pharmacology for ELIQUIS
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Synonyms for ELIQUIS
1-(4-Methoxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid amide
1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo(3,4c)pyridine-3-carboxamide
1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo piperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidyl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxamide
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridine-3-carboxamide
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-car
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxamide
1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide?BMS-562247; BMS-562247-01
1H-Pyrazolo(3,4-c)pyridine-3-carboxamide,4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-
1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-
2p16
3Z9Y7UWC1J
503612-47-3
612A473
AB0007933
AB01565766_02
AB1008435
ABP000333
AC-26301
AJ-59962
AKOS005146204
AN-429
AOB87769
Apixaban
Apixaban - Adooq Bioscience
Apixaban (BMS 562247-01)
Apixaban (JAN/USAN/INN)
Apixaban [USAN:INN:JAN]
Apixaban BMS-562247-01
Apixaban,BMS-562247-01
Apixaban;503612-47-3
Apixaban(BMS-562247-01)
Apixaban/BMS562247-01/Apixaban
apixabanum
Apixabin
AX8161411
BC654125
BCP02451
BCP9000310
BCPP000396
BDBM19023
BMS 562247-01
BMS-562247
BMS-562247-01
BMS562247-01
CA0186
CCG-229675
CHEBI:72296
CHEMBL231779
CS-0401
D03213
DB06605
DTXSID80436500
Eliquis (TN)
EX-A048
FT-0686944
GG2
GTPL6390
HMS3655O07
HSDB 8223
HY-50667
I14-11577
J-200194
KB-47429
KS-0000075V
ME-0152
MLS006010026
MolPort-006-170-153
NCGC00346555-01
NCGC00346555-08
PB10976
PYR431
Q-4456
QC-8191
QNZCBYKSOIHPEH-UHFFFAOYSA-N
RP18047
s1593
SC-49755
SCHEMBL118023
SMR004676529
ST24045978
SW220177-1
UNII-3Z9Y7UWC1J
X1060
ZINC11677837
Paragraph IV (Patent) Challenges for ELIQUIS
Tradename Dosage Ingredient NDA Submissiondate
ELIQUIS TABLET;ORAL apixaban 202155 2016-12-28

US Patents and Regulatory Information for ELIQUIS

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 202155-001 Dec 28, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   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 ELIQUIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1427415 PA2011012,C1427415 Lithuania   Start Trial PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518
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 20110518
1427415 CA 2011 00028 Denmark   Start Trial
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 122011100050 Germany   Start Trial PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; 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 2011C/034 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Mallinckrodt

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