Details for New Drug Application (NDA): 210563
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NDA 210563 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 210563
| Tradename: | IMBRUVICA |
| Applicant: | Pharmacyclics Llc |
| Ingredient: | ibrutinib |
| Patents: | 37 |
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: | Aug 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Aug 2, 2024 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Regulatory Exclusivity Expiration: | Aug 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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