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BRILINTA Drug Profile

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Which patents cover Brilinta, and when can generic versions of Brilinta launch?

Brilinta is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

US ANDA Litigation and Generic Entry Outlook for Brilinta

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A generic version of BRILINTA was approved as ticagrelor by HISUN PHARM HANGZHOU on January 20^th, 2020.

Summary for BRILINTA

International Patents:	216
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	77
Clinical Trials:	77
Patent Applications:	104
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BRILINTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRILINTA
DailyMed Link:	BRILINTA at DailyMed

Drug patent expirations by year for BRILINTA

Recent Clinical Trials for BRILINTA

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

Sponsor	Phase
Janssen, LP	Phase 4
HonorHealth Research Institute	Phase 2
Ottawa Heart Institute Research Corporation	Phase 4

See all BRILINTA clinical trials

Recent Litigation for BRILINTA

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 BRILINTA litigation

Pharmacology for BRILINTA

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 BRILINTA

(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 (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
Ticagrelor (Brilinta,AZD6140)
Ticagrelor (JAN/USAN/INN)
Ticagrelor [USAN:INN:BAN]
TICARGRELOR
UNII-GLH0314RVC
YF10110
Z1937
ZINC28957444

Paragraph IV (Patent) Challenges for BRILINTA

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 BRILINTA

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Glossary

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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		Start Trial
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes	Start Trial	Start Trial				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
>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 BRILINTA

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BRILINTA

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Country	Patent Number	Estimated Expiration
Malaysia	148652	Start Trial
Australia	6287401	Start Trial
Russian Federation	2012121883	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for BRILINTA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	SPC/GB11/016	United Kingdom	Start Trial	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	C01135391/01	Switzerland	Start Trial	FORMER REPRESENTATIVE: BOHEST AG, CH
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description