Details for New Drug Application (NDA): 022433

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NDA 022433 describes BRILINTA, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BRILINTA profile page.

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 022433

Tradename:	BRILINTA
Applicant:	Astrazeneca Pharms
Ingredient:	ticagrelor
Patents:	6
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022433

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

Suppliers and Packaging for NDA: 022433

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRILINTA	ticagrelor	TABLET;ORAL	022433	NDA	AstraZeneca Pharmaceuticals LP	0186-0776	0186-0776-60	60 TABLET in 1 BOTTLE (0186-0776-60)
BRILINTA	ticagrelor	TABLET;ORAL	022433	NDA	AstraZeneca Pharmaceuticals LP	0186-0776	0186-0776-94	1 BLISTER PACK in 1 BOX, UNIT-DOSE (0186-0776-94) > 14 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Jul 20, 2011	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 3, 2018
Regulatory Exclusivity Use:	EXTENDS THE 2011 APPROVAL OF BRILINTA FOR USE BEGINNING WITH ACS TO USE BEGINNING MORE REMOTE FROM MYOCARDIAL INFARCTION
Patent:	➤ Sign Up	Patent Expiration:	Jul 15, 2018	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Dec 2, 2019	Product Flag?	Y	Substance Flag?	Y	Delist Request?	Y
Patented Use:	REDUCTION OF THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN PATIENTS WITH ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION

Expired US Patents for NDA 022433

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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	➤ Sign Up	➤ Sign Up
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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