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Last Updated: December 14, 2019

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Ticagrelor - Generic Drug Details

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

Ticagrelor is the generic ingredient in two branded drugs marketed by Astrazeneca Pharms, Amneal Pharms Co, Hisun Pharm Hangzhou, and Watson Labs Inc, and is included in four NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ticagrelor has two hundred and sixteen patent family members in forty-eight countries.

There are twenty-one drug master file entries for ticagrelor. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for ticagrelor

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

SponsorPhase
Assiut UniversityPhase 1
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
IRW consulting ABPhase 3

See all ticagrelor clinical trials

Recent Litigation for ticagrelor

Identify potential future generic entrants

District Court Litigation
Case NameDate
AstraZeneca LP v. Hisun Pharmaceutical Co., Ltd.2018-08-10
AstraZeneca LP v. Prinston Pharmaceutical Inc.2017-11-13
AstraZeneca LP v. Watson Laboratories Inc.2016-05-09

See all ticagrelor litigation

Generic filers with tentative approvals for TICAGRELOR
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial90MGTABLET;ORAL
  Start Trial  Start Trial90MGTABLET;ORAL
  Start Trial  Start Trial60MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for ticagrelor
(1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-(7-((1R,2S)-2-(3,4-Difluorophenyl)cyclopropylamino)-5-(propylthio)-3H-(1,2,3)triazolo(4,5-d)pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-(7-((1R,2S)-2-(3,4-difluorophenyl)cyclopropylamino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy) cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-(7-((1R,2S)-2-(3,4-difluorophenyl)cyclopropylamino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2 diol
(1S,2S,3R,5S)-3-(7-((1R,2S)-2-(3,4-difluorophenyl)cyclopropylamino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-(7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylsulfanyl)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1s,2s,3r,5s)-3-[7-[[(1r,2s)-2-(3,4-difluorophenyl)-cyclopropyl]amino]-5-(propylthio)-3h-[1,2,3]-triazolo[4,5-d]pyrimidine-3-yl]-5-(2-hydroxyethoxy) cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-DIFLUOROPHENYL)CYCLOPROPYL]AMINO]-5-(PROPYLTHIO)-3H-1,2,3-TRIAZOLO[4,5-D]PYRIMIDIN-3-YL]-5-(2-HYDROXYETHOXY)-1,2-CYCLOPENTANEDIOL
(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-propylsulfanyl-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-propylsulfanyltriazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-propylsulfanyltriazolo[5,4-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
(1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylsulfanyl)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
[14C]-Ticagrelor
1,2-Cyclopentanediol, 3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-1,2,3-triazolo(4,5-d)pyrimidin-3-yl)-5-(2-hydroxyethoxy)-, (1S,2S,3R,5S)-
274693-27-5
693T275
AB0072975
AB01565855_02
AC-24755
AKOS015900739
AM85693
AMMD00027
AMX10144
AN-6416
API0007655
AR-C 126532XX
AR-C126532
AR-C126532XX
AS-19943
AX8217107
AZD 6140
AZD-6140
AZD6140
BC656855
BDBM50397205
Brilinta
Brilinta (TN)
Brilique
C23H28F2N6O4S
CHEBI:68558
CHEMBL398435
compound 17 [PMID: 17827008]
CS-0619
CT0197
D09017
DB08816
EX-6274
EX-A503
GLH0314RVC
GTPL1765
HSDB 8306
HY-10064
I14-16380
J-016772
J-524969
KB-61730
MolPort-023-329-971
NCGC00379052-02
OEKWJQXRCDYSHL-FNOIDJSQSA-N
PB23768
Q-4401
RL02931
s4079
SCHEMBL1979652
Ticagrelor (Brilinta,AZD6140)
Ticagrelor (JAN/USAN/INN)
Ticagrelor [USAN:INN:BAN]
TICARGRELOR
UNII-GLH0314RVC
YF10110
Z1937
ZINC28957444
Paragraph IV (Patent) Challenges for TICAGRELOR
Tradename Dosage Ingredient NDA Submissiondate
BRILINTA TABLET;ORAL ticagrelor 022433 2015-09-30
BRILINTA TABLET;ORAL ticagrelor 022433 2015-07-20

US Patents and Regulatory Information for ticagrelor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No   Start Trial   Start Trial Y Y Y   Start Trial
Watson Labs Inc TICAGRELOR ticagrelor TABLET;ORAL 208390-001 Sep 4, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes   Start Trial   Start Trial Y   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 ticagrelor

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ticagrelor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135391 122011100004 Germany   Start Trial PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391 PA2011004 Lithuania   Start Trial PRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
1135391 91819 Luxembourg   Start Trial 91819, EXPIRES: 20241202
1135391 C01135391/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1135391 11C0016 France   Start Trial PRODUCT NAME: TICAGRELOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/10/655/001 DU 20101203; REGISTRATION NO/DATE AT EEC: EU/1/10/655/001-006 DU 20101203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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