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Last Updated: December 5, 2019

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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 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.

Summary for apixaban

International Patents:	159
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	30
Suppliers / Packagers:	6
Bulk Api Vendors:	101
Clinical Trials:	145
Patent Applications:	1,806
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for apixaban
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apixaban
DailyMed Link:	apixaban at DailyMed

See drug sales revenues for apixaban

Recent Clinical Trials for apixaban

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

Sponsor	Phase
Yale University	Phase 3
University Hospital, Caen	Phase 1
University Hospital, Rouen	Phase 1

See all apixaban clinical trials

Recent Litigation for apixaban

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Petitioner	Date
Mylan Pharmaceuticals Inc.	2018-04-05
Coalition for Affordable Drugs IX, LLC	2015-08-13

See all apixaban litigation

Generic filers with tentative approvals for APIXABAN

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	5MG	TABLET;ORAL
Start Trial	Start Trial	2.5MG	TABLET;ORAL
Start Trial	Start Trial	5MG	TABLET;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 Class	Factor Xa Inhibitor
Mechanism of Action	Factor 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

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Glossary

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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

International Patents for apixaban

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Country	Patent Number	Estimated Expiration
Germany	122011100050	Start Trial
Argentina	067965	Start Trial
Poland	204263	Start Trial
Brazil	0212726	Start Trial
South Korea	100908176	Start Trial
Croatia	P20190430	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for apixaban

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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.

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