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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 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-nine patent family members in forty countries.

There are twenty-seven drug master file entries for apixaban. Three suppliers are listed for this compound.

Summary for apixaban

International Patents:	139
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	27
Suppliers / Packagers:	3
Bulk Api Vendors:	91
Clinical Trials:	118
Patent Applications:	1,439
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apixaban
DailyMed Link:	apixaban at DailyMed

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[3,4-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

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

503612-47-3

612A473

AB0007933

AB01565766_02

AB1008435

ABP000333

AC-26301

AJ-59962

AK161862

AKOS005146204

AN-429

AOB87769

Apixaban - Adooq Bioscience

Apixaban (BMS 562247-01)

Apixaban (JAN/USAN/INN)

Apixaban [USAN]

Apixaban BMS-562247-01

Apixaban,BMS-562247-01

Apixaban;503612-47-3

Apixaban(BMS-562247-01)

Apixaban/BMS562247-01/Apixaban

apixabanum

Apixabin

AX8161411

BC654125

BCP9000310

BCPP000396

BDBM19023

BMS 562247

BMS 562247-01

BMS-562247

BMS-562247-01

BMS-562247-01, Apixaban

BMS562247-01

CA0186

CCG-229675

CHEBI:72296

CHEMBL231779

CS-0401

D03213

D0I5HF

DB06605

DTXSID80436500

Eliquis

Eliquis (TN)

EX-A048

FT-0686944

GG2

GTPL6390

HE069298

HE346199

HMS3655O07

HY-50667

I14-11577

J-200194

KB-47429

KS-0000075V

ME-0152

MFCD11977295

MLS006010026

MolPort-006-170-153

NCGC00346555-01

PB10976

PYR431

Q-4456

QC-8191

QNZCBYKSOIHPEH-UHFFFAOYSA-N

ro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid amide

RP18047

s1593

SC-49755

SCHEMBL118023

SMR004676529

ST24045978

UNII-3Z9Y7UWC1J

X1060

ZINC11677837

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

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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
6,673,810	Imidazo-heterobicycles as factor Xa inhibitors
6,858,616	Nitrogen containing heterobicycles as factor Xa inhibitors
6,989,391	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
6,995,172	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors

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International Patents for apixaban

Country	Document Number	Estimated Expiration
Iceland	2824
Slovenia	1427415
New Zealand	511674
Croatia	P990396

Supplementary Protection Certificates for apixaban

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
11/032	Ireland		PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
3	Finland
2011012,C1427415	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518