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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 fifty 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. Two suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

Summary for BRILINTA

International Patents:	250
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	67
Clinical Trials:	73
Patent Applications:	96
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

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

US Patents and Regulatory Information for BRILINTA

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
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes			Y	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	022433-002	Sep 3, 2015	AB	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	022433-002	Sep 3, 2015	AB	RX	Yes	No			Y
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes				Y

Expired US Patents for BRILINTA

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

Paragraph IV (Patent) Challenges for BRILINTA

Drugname	Dosage	Strength	RLD	Date
	Tablets	60 mg
	Tablets	90 mg

International Patents for BRILINTA

Country	Document Number	Estimated Expiration
Egypt	24412
Poland	2056832
Russian Federation	2007133926
South Africa	9806050
Singapore	135965
Norway	20012725
Cyprus	1111759

Supplementary Protection Certificates for BRILINTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0016	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
2011004,C1135391	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
2011100004	Germany		PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
90009-9	Sweden		PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
2011 00013	Denmark		PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
6	Finland
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