Details for New Drug Application (NDA): 210259
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NDA 210259 describes CALQUENCE, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the CALQUENCE profile page.
The generic ingredient in CALQUENCE is acalabrutinib maleate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acalabrutinib maleate profile page.
The generic ingredient in CALQUENCE is acalabrutinib maleate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acalabrutinib maleate profile page.
Summary for 210259
| Tradename: | CALQUENCE |
| Applicant: | Astrazeneca |
| Ingredient: | acalabrutinib |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210259
Generic Entry Date for 210259*:
Constraining patent/regulatory exclusivity:
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: 210259
| Mechanism of Action | Tyrosine Kinase Inhibitors |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 31, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA (MCL) WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) | ||||||||
| Regulatory Exclusivity Expiration: | Nov 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | ||||||||
| Regulatory Exclusivity Expiration: | Feb 19, 2029 | ||||||||
| Regulatory Exclusivity Use: | USE WITH VENETOCLAX AS A NEW COMBINATION REGIMEN FOR THE TREATMENT OFADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA | ||||||||
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