Details for New Drug Application (NDA): 217003
NDA 217003 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Llc and is included in three NDAs. It is available from one supplier. There are fifty-seven patents protecting this drug and four Paragraph IV challenges. Additional details are available on the IMBRUVICA profile page.
The generic ingredient in IMBRUVICA is ibrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
The generic ingredient in IMBRUVICA is ibrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
Summary for 217003
| Tradename: | IMBRUVICA |
| Applicant: | Pharmacyclics Llc |
| Ingredient: | ibrutinib |
| Patents: | 31 |
Pharmacology for NDA: 217003
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 217003
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMBRUVICA | ibrutinib | SUSPENSION;ORAL | 217003 | NDA | Pharmacyclics LLC | 57962-007 | 57962-007-12 | 1 BOTTLE, GLASS in 1 CARTON (57962-007-12) / 108 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 70MG/ML | ||||
| Approval Date: | Aug 24, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Feb 24, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 24, 2030 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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