Details for New Drug Application (NDA): 216387
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NDA 216387 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 216387
| Tradename: | CALQUENCE |
| Applicant: | Astrazeneca |
| Ingredient: | acalabrutinib maleate |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216387
Generic Entry Date for 216387*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 216387
| Mechanism of Action | Tyrosine Kinase Inhibitors |
Suppliers and Packaging for NDA: 216387
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387 | NDA | AstraZeneca Pharmaceuticals LP | 0310-3512 | 0310-3512-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60) |
| CALQUENCE | acalabrutinib maleate | TABLET;ORAL | 216387 | NDA | AstraZeneca Pharmaceuticals LP | 0310-3512 | 0310-3512-95 | 60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Aug 3, 2022 | 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: | 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 | ||||||||
| Patent: | 10,239,883 | Patent Expiration: | Jul 11, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA | ||||||||
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