Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Apixaban - Generic Drug Details

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What are the generic drug sources for apixaban and what is the scope of 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 fifty-nine patent family members in forty-three countries.

There are thirty drug master file entries for apixaban. Six 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
Yale UniversityPhase 3
University Hospital, CaenPhase 1
University Hospital, RouenPhase 1

See all apixaban clinical trials

Recent Litigation for apixaban

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 apixaban litigation

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

See all apixaban litigation

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
Synonyms for apixaban
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 - 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
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 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 202155-001 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 202155-002 Dec 28, 2012 RX Yes Yes   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   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 apixaban

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 C01427415/01 Switzerland   Start Trial FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
1427415 PA2011012 Lithuania   Start Trial PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518
1427415 91888 Luxembourg   Start Trial 91888, EXPIRES: 20260518
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 C20110017 00045 Estonia   Start Trial PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.