Ticagrelor Oral Tablet

Brand(s)
Brilinta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Lp (2015-09-04)
Oldest Current Product
2011-08-05
License(s)
NDA
RxNORM
ORAL TABLET\TICAGRELOR
FDAOB
ORAL\TABLET\TICAGRELOR
SPL Active
ORAL\TABLET\TICAGRELOR
SPL Moiety
ORAL\TABLET\TICAGRELOR

product(s) by strength(s)

ticagrelor 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860776BrilintaNDAAstrazeneca Lp2015-09-04TICAGRELORORALTABLETNDA022433f7b3f443-e83d-4bf2-0e96-023448fed9a8

ticagrelor 90 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860777BrilintaNDAAstrazeneca Lp2011-08-05TICAGRELORORALTABLETNDA022433f7b3f443-e83d-4bf2-0e96-023448fed9a8

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551549618BrilintaNDACardinal Health2011-08-05TICAGRELORORALTABLET001860777NDA0224334f9bd52a-99a7-4606-92b4-456a917aabef
2636295292BrilintaNDABryant Ranch Prepack2011-08-05TICAGRELORORALTABLET001860777NDA0224333ce9ee32-b18b-4ef3-b127-ce479d520e1a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022433BRILINTAASTRAZENECA LP2011-07-20p7265124, REDUCTION OF THE RATE OF THROMBOTIC EVENTS IN PATIENTS WITH ACUTE CORONARY SYNDROME, SUBSTANCE
p6251910
p8425934, SUBSTANCE
p7250419, REDUCTION OF THE RATE OF THROMBOTIC EVENTS IN PATIENTS WITH ACUTE CORONARY SYNDROME, SUBSTANCE
p6525060, REDUCTION OF THE RATE OF THROMBOTIC EVENTS IN PATIENTS WITH ACUTE CORONARY SYNDROME, SUBSTANCE
EXTENDS THE 2011 APPROVAL OF BRILINTA FOR USE BEGINNING WITH ACS TO USE BEGINNING MORE REMOTE FROM MYOCARDIAL INFRACTION [2018-09-03]
NEW STRENGTH [2018-09-03]
NEW CHEMICAL ENTITY [2016-07-20]
NDA022433_001, NDA022433_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022433_001RXTICAGRELOR (90MG)ORALTABLETTrue2011-07-20BRILINTA
2NDA022433_002RXTICAGRELOR (60MG)ORALTABLETFalse2015-09-03BRILINTA

patent(s)

#idexpiration dateapplication(s)
1p6251910 (view patent)2018-07-15NDA022433
2p6525060 (view patent)2019-12-02NDA022433
3p7250419 (view patent)2019-12-02NDA022433
4p7265124 (view patent)2021-07-09NDA022433
5p8425934 (view patent)2030-04-17NDA022433

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13ce9ee32-b18b-4ef3-b127-ce479d520e1a (view SPL)These highlights do not include all the information needed to use BRILINTA safely and effectively. See full prescribing information for BRILINTA.BRILINTA (ticagrelor) tablets, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231000636295292
24f9bd52a-99a7-4606-92b4-456a917aabef (view SPL)These highlights do not include all the information needed to use BRILINTA safely and effectively. See full prescribing information for BRILINTA. BRILINTA (ticagrelor) tablets, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionCardinal HealthREPACK2015-09-232551549618
3f7b3f443-e83d-4bf2-0e96-023448fed9a8 (view SPL)These highlights do not include all the information needed to use BRILINTA safely and effectively. See full prescribing information for BRILINTA. BRILINTA (ticagrelor) tablets, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionAstrazeneca Lp2015-09-0423001860776, 001860777

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII