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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.
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: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Jul 20, 2011 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Jan 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION (MI), AND STROKE IN A PATIENT RECEIVING 75-100 MG ASPIRIN DAILY WITH A HISTORY OF MI BY ADMINISTERING 60 MG TICAGRELOR TWICE DAILY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jan 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN A PATIENT RECEIVING 75-100 MG ASPIRIN DAILY AND HAVING OR WHO HAD ACUTE CORONARY SYNDROME BY ADMINISTERING 60 MG TICAGRELOR TWICE DAILY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jul 9, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| 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 | 022433-001 | 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 | 022433-002 | 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 | 022433-001 | Jul 20, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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