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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 Lp and is included in one NDA. It is available from three suppliers. There are five 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 eighteen 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 NDA: 022433

Tradename:
BRILINTA
Applicant:
Astrazeneca Lp
Ingredient:
ticagrelor
Patents:5
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG
Approval Date:Jul 20, 2011TE:RLD:Yes
Patent:6,251,910Patent Expiration:Jul 15, 2018Product Flag?Substance Flag?YDelist Request?
Patent:8,425,934Patent Expiration:Apr 17, 2030Product Flag?YSubstance Flag?Delist Request?
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 INFRACTION


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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 verifification 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.

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