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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 ticagrelor 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 five 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 eight patent family members in forty-eight countries.

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

Summary for ticagrelor

International Patents:	208
US Patents:	5
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	21
Suppliers / Packagers:	3
Bulk Api Vendors:	74
Clinical Trials:	311
Patent Applications:	188
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ticagrelor
DailyMed Link:	ticagrelor at DailyMed

Pharmacology for ticagrelor

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	Phenylalanine Hydroxylase Activators P2Y12 Receptor Antagonists Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors
Physiological Effect	Decreased Platelet Aggregation

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

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	AB	RX	Yes	No			Y	Y
Watson Labs Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208390-002	Sep 4, 2018		DISCN	No	No
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes			Y	Y
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes			Y	Y

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
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011

International Patents for ticagrelor

Country	Patent Number	Estimated Expiration
Denmark	2056832
Brazil	0111328
Norway	2011007
New Zealand	522638

Supplementary Protection Certificates for ticagrelor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	91819	Luxembourg		91819, EXPIRES: 20241202
1135391	SPC/GB11/016	United Kingdom		PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/10/655/001 20101203; UK EU/1/10/655/002 20101203; UK EU/1/10/655/003 20101203; UK EU/1/10/655/004 20101203; UK EU/1/10/655/005 20101203; UK EU/1/10/655/006 20101203
1135391	122011100004	Germany		PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	11C0016	France		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