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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 and Watson Labs Inc, and is included in two NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for ticagrelor

US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	21
Suppliers / Packagers:	2
Bulk Api Vendors:	65
Clinical Trials:	275
Patent Applications:	184
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]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

AK-59715

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)

Brilinta/Brilique

Brilique

C23H28F2N6O4S

CHEBI:68558

CHEMBL398435

compound 17 [PMID: 17827008]

CS-0619

CT0197

D04PMQ

D09017

D0WF7L

DB08816

EUCLID

EX-6274

EX-A503

GLH0314RVC

GTPL1765

HSDB 8306

HY-10064

I14-16380

J-016772

J-524969

KB-61730

MFCD09954148

MolPort-023-329-971

OEKWJQXRCDYSHL-FNOIDJSQSA-N

PB23768

Possia

Q-4401

RL02931

s4079

SCHEMBL1979652

Ticagrelor (Brilinta,AZD6140)

Ticagrelor (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	022433-001	Jul 20, 2011	AB	RX	Yes	Yes			Y	Y
Watson Labs Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208390-001	Sep 4, 2018	AB	RX	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	Document Number	Estimated Expiration
Czech Republic	300280
Russian Federation	2012153069
Russian Federation	2325391
Russian Federation	2010150799

Supplementary Protection Certificates for ticagrelor

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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
1135391/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
2011 00013	Denmark		PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
819	Luxembourg		91819, EXPIRES: 20241202