Apixaban - Generic Drug Details

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What are the generic drug sources for apixaban and what is the scope of patent protection?

Apixaban is the generic ingredient in two branded drugs marketed by Bionpharma Inc, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in four 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 fifty-one patent family members in forty-two countries.

There are thirty drug master file entries for apixaban. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for apixaban

International Patents:	151
US Patents:	2
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	30
Suppliers / Packagers:	5
Bulk Api Vendors:	104
Clinical Trials:	157
Patent Applications:	1,865
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
Bayer	Phase 3
ACCP Research Institute	Phase 1
University of Texas at Austin	Phase 3

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
	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-piperidinyl)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]-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-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
AK161862
AKOS005146204
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
AR-270/43507990
AX8161411
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
J-200194
KS-0000075V
ME-0152
MLS006010026
NCGC00346555-01
NCGC00346555-08
PB10976
PYR431
Q-4456
Q414462
QC-8191
QNZCBYKSOIHPEH-UHFFFAOYSA-N
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	AB	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Micro Labs	APIXABAN	apixaban	TABLET;ORAL	210013-001	Dec 23, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No	Start Trial	Start Trial	Y	Y		Start Trial
Bionpharma Inc	APIXABAN	apixaban	TABLET;ORAL	210152-002	Apr 8, 2020	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Mylan	APIXABAN	apixaban	TABLET;ORAL	210128-001	Dec 23, 2019		DISCN	No	No	Start Trial	Start Trial				Start Trial
Bionpharma Inc	APIXABAN	apixaban	TABLET;ORAL	210152-001	Apr 8, 2020	AB	RX	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

Expired US Patents for apixaban

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	Start Trial	Start Trial
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for apixaban

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Country	Patent Number	Estimated Expiration
Germany	122011100050	Start Trial
Serbia	59593	Start Trial
New Zealand	531616	Start Trial
Hong Kong	1061973	Start Trial
Serbia	58699	Start Trial
China	109602716	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	31/2011	Austria	Start Trial	PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520
1427415	CA 2011 00028	Denmark	Start Trial
1427415	115 5011-2011	Slovakia	Start Trial	OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH
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	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	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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