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. Four suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 022433
Tradename: | BRILINTA |
Applicant: | Astrazeneca |
Ingredient: | ticagrelor |
Patents: | 3 |
Pharmacology for NDA: 022433
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
Physiological Effect | Decreased Platelet Aggregation |
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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Jul 20, 2011 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | May 9, 2025 | ||||||||
Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HESTIA3 | ||||||||
Regulatory Exclusivity Expiration: | May 5, 2024 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Regulatory Exclusivity Expiration: | Nov 9, 2025 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY |
Expired US Patents for NDA 022433
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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