small molecule

CALQUENCE

ACALABRUTINIB MALEATE

Loss of exclusivityJuly 2036latest FDA-listed patent expiry
CompanyASTRAZENECA UK LTD

Drug detail

Brand nameCALQUENCE
Active ingredientACALABRUTINIB MALEATE
StrengthEQ 100MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2022
Marketing statusRX

Listed patents

PatentExpiresType
11059829July 2036substance, product
11166951August 2035use U-4431
11771696January 2035use U-3710
10272083January 2035use U-2687
9758524July 2032use U-2145
10239883July 2032use U-2668
9290504July 2032substance, product
7459554November 2026substance

Regulatory exclusivity

CodeExpires
D-200February 2029
I-960January 2028

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.