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 nine patents protecting this drug. Additional details are available on the CALQUENCE profile page.
The generic ingredient in CALQUENCE is acalabrutinib maleate. 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. 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: | 8 |
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 |
Suppliers and Packaging for NDA: 210259
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0512 | 0310-0512-60 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-60) |
| CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0512 | 0310-0512-95 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-95) |
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: | 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: | Oct 31, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 1, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA | ||||||||
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