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Generated: September 23, 2018

DrugPatentWatch Database Preview

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
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:RXDosage:TABLET;ORALStrength90MG
Approval Date:Jul 20, 2011TE:ABRLD: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 UpPatent Expiration:Jul 15, 2018Product Flag?Substance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Dec 2, 2019Product Flag?YSubstance Flag?YDelist 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

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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