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ELIQUIS Drug Profile

Which patents cover Eliquis, and what generic alternatives are available?

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.

This drug has one hundred and fifty-eight patent family members in forty-two countries.

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

Summary for ELIQUIS

International Patents:	158
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	6
Bulk Api Vendors:	101
Clinical Trials:	55
Patent Applications:	1,032
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ELIQUIS
Drug Sales Revenues:	Drug sales revenues for ELIQUIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIQUIS
DailyMed Link:	ELIQUIS at DailyMed

Drug patent expirations by year for ELIQUIS

Generic Entry Opportunity Date for ELIQUIS

Generic Entry Date for ELIQUIS^: See Pricing* Constraining patent/regulatory exclusivity: See Pricing 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.

Recent Clinical Trials for ELIQUIS

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

Sponsor	Phase
Yale University	Phase 3
University of Zurich	Phase 3
St. Michael's Hospital, Toronto	Phase 2

See all ELIQUIS clinical trials

Recent Litigation for ELIQUIS

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 ELIQUIS litigation

PTAB Litigation

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

See all ELIQUIS litigation

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(3,4c)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
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 (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

US Patents and Regulatory Information for ELIQUIS

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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	See Pricing	See Pricing	Y	Y		See Pricing
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012		RX	Yes	No	See Pricing	See Pricing	Y	Y		See Pricing
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012		RX	Yes	No	See Pricing	See Pricing	Y			See Pricing
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012		RX	Yes	Yes	See Pricing	See Pricing	Y	Y		See Pricing
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012		RX	Yes	Yes	See Pricing	See Pricing	Y			See Pricing
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012		RX	Yes	Yes	See Pricing	See Pricing	Y	Y		See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Paragraph IV (Patent) Challenges for ELIQUIS

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	2.5 mg and 5 mg	➤ Subscribe	See Pricing

International Patents for ELIQUIS

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Country	Patent Number	Estimated Expiration
Georgia, Republic of	P20074098	See Pricing
China	102770126	See Pricing
Hungary	228195	See Pricing
Montenegro	P58108	See Pricing
Hong Kong	1061973	See Pricing
Spain	2714363	See Pricing
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ELIQUIS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	443	Finland	See Pricing
1427415	91888	Luxembourg	See Pricing	91888, EXPIRES: 20260518
1427415	C300500	Netherlands	See Pricing	PRODUCT NAME: APIXABAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	1190029-7	Sweden	See Pricing	PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415	122011100050	Germany	See Pricing	PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	2011C/034	Belgium	See Pricing	PRODUCT NAME: APIXABAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, SOUS TOUTES FORMES BEBEFICIANT DE LA PROTECTION DU BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/0/11/691/001 20110520
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description