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Details for New Drug Application (NDA): 022433
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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? | |||
Patent: | Start Trial | Patent Expiration: | Jul 9, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | Start Trial | Patent Expiration: | Apr 17, 2030 | Product Flag? | Y | Substance 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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