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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.

Summary for ticagrelor

International Patents:	216
US Patents:	6
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	21
Suppliers / Packagers:	3
Bulk Api Vendors:	76
Clinical Trials:	325
Patent Applications:	194
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ticagrelor
DailyMed Link:	ticagrelor at DailyMed

Recent Clinical Trials for ticagrelor

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

Sponsor	Phase
Assiut University	Phase 1
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
IRW consulting AB	Phase 3

See all ticagrelor clinical trials

Recent Litigation for ticagrelor

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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
		90MG	TABLET;ORAL
		90MG	TABLET;ORAL
		60MG	TABLET;ORAL

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

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

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			Y	Y	Y
Watson Labs Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208390-001	Sep 4, 2018		DISCN	No	No
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No			Y	Y
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

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
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011
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
Japan	5385139
Singapore	135965
Singapore	177162
Argentina	058967
Poland	392882

Supplementary Protection Certificates for ticagrelor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	122011100004	Germany		PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	PA2011004	Lithuania		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		91819, EXPIRES: 20241202
1135391	C01135391/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
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