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Last Updated: March 28, 2024

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 two 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. Three 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
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: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

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.