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Last Updated: January 25, 2021

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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 four 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 Pharms
Ingredient:ticagrelor
Patents:4
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
Paragraph IV (Patent) Challenges for 022433
Tradename Dosage Ingredient NDA Submissiondate
BRILINTA TABLET;ORAL ticagrelor 022433 2015-09-30
BRILINTA TABLET;ORAL ticagrelor 022433 2015-07-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG
Approval Date:Jul 20, 2011TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 27, 2036Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 9, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Apr 17, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022433

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

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