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Details for New Drug Application (NDA): 022433
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.
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 | N | 0186-0776-60 |
| BRILINTA | ticagrelor | TABLET;ORAL | 022433 | NDA | AstraZeneca Pharmaceuticals LP | 0186-0776 | N | 0186-0776-94 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Jul 20, 2011 | TE: | RLD: | 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: | ➤ Try a Free Trial | Patent Expiration: | Jul 15, 2018 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Dec 2, 2019 | Product Flag? | Y | Substance Flag? | Y | Delist 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 | ||||||||
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