Details for New Drug Application (NDA): 022433

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NDA 022433 describes BRILINTA, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There are three 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. Four suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

Summary for 022433

Tradename:	BRILINTA
Applicant:	Astrazeneca
Ingredient:	ticagrelor
Patents:	3

Pharmacology for NDA: 022433

Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists
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:	May 9, 2025
Regulatory Exclusivity Use:	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HESTIA3
Regulatory Exclusivity Expiration:	May 5, 2024
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Nov 9, 2025
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 022433

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	⤷ Subscribe	⤷ Subscribe
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	⤷ Subscribe	⤷ Subscribe
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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