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ELIQUIS Drug Profile

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Which patents cover Eliquis, and when can generic versions of Eliquis launch?

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.

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

Summary for ELIQUIS

US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	4
Bulk Api Vendors:	92
Clinical Trials:	40
Patent Applications:	833
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ELIQUIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIQUIS
DailyMed Link:	ELIQUIS at DailyMed

Generic Entry Opportunity Date for ELIQUIS

NDA:

202155

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.

Pharmacology for ELIQUIS

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor 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[3,4-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

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

Paragraph IV (Patent) Challenges for ELIQUIS

Drugname	Dosage	Strength	RLD	Date
	Tablets	2.5 mg and 5 mg

International Patents for ELIQUIS

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	0039131
Portugal	1140941
Mexico	PA04002526
Slovenia	1427415
China	104744461
Japan	4249621
Japan	2016065086

Supplementary Protection Certificates for ELIQUIS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
90029-7	Sweden		PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
2011012,C1427415	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518
0110017 00045	Estonia		PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
C0042	France		PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110518
2011012	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518
2011 00028	Denmark