Details for New Drug Application (NDA): 205552
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NDA 205552 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Inc and is included in three NDAs. It is available from one supplier. There are fifty-five 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 Inc |
| Ingredient: | ibrutinib |
| Patents: | 36 |
| Formulation / Manufacturing: | see details |
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: | May 6, 2023 | ||||||||
| Regulatory Exclusivity Use: | FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 4, 2023 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITHOUT 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE THERAPY) | ||||||||
| Regulatory Exclusivity Expiration: | Jan 25, 2022 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | ||||||||
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