Details for New Drug Application (NDA): 205552
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NDA 205552 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-four 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 are sixteen drug master file entries 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 are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
Summary for 205552
| Tradename: | IMBRUVICA |
| Applicant: | Pharmacyclics Llc |
| Ingredient: | ibrutinib |
| Patents: | 35 |
Pharmacology for NDA: 205552
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 205552
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552 | NDA | Pharmacyclics LLC | 57962-070 | 57962-070-28 | 28 CAPSULE in 1 BOTTLE, PLASTIC (57962-070-28) |
| IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552 | NDA | Pharmacyclics LLC | 57962-140 | 57962-140-09 | 90 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 140MG | ||||
| Approval Date: | Nov 13, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Aug 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Feb 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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