Details for New Drug Application (NDA): 210563
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NDA 210563 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 210563
| Tradename: | IMBRUVICA |
| Applicant: | Pharmacyclics Inc |
| Ingredient: | ibrutinib |
| Patents: | 36 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210563
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 210563
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMBRUVICA | ibrutinib | TABLET;ORAL | 210563 | NDA | Pharmacyclics LLC | 57962-014 | 57962-014-28 | 1 BLISTER PACK in 1 CARTON (57962-014-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
| IMBRUVICA | ibrutinib | TABLET;ORAL | 210563 | NDA | Pharmacyclics LLC | 57962-280 | 57962-280-28 | 1 BLISTER PACK in 1 CARTON (57962-280-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 140MG | ||||
| Approval Date: | Feb 16, 2018 | TE: | RLD: | Yes | |||||
| 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 | ||||||||
| Regulatory Exclusivity Expiration: | Aug 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Feb 24, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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