Details for New Drug Application (NDA): 213217
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NDA 213217 describes BRUKINSA, which is a drug marketed by Beone Medicines Usa and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the BRUKINSA profile page.
The generic ingredient in BRUKINSA is zanubrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zanubrutinib profile page.
The generic ingredient in BRUKINSA is zanubrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zanubrutinib profile page.
Summary for 213217
| Tradename: | BRUKINSA |
| Applicant: | Beone Medicines Usa |
| Ingredient: | zanubrutinib |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213217
Generic Entry Date for 213217*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 213217
| Mechanism of Action | Bruton's Tyrosine Kinase Inhibitors |
Suppliers and Packaging for NDA: 213217
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217 | NDA | BeOne Medicines USA, Inc. | 72579-011 | 72579-011-02 | 1 BOTTLE, PLASTIC in 1 CARTON (72579-011-02) / 120 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 80MG | ||||
| Approval Date: | Nov 14, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 19, 2030 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | ||||||||
| Regulatory Exclusivity Expiration: | Nov 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 19, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | ||||||||
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