small molecule

CALQUENCE

ACALABRUTINIB

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

Drug detail

Brand nameCALQUENCE
Active ingredientACALABRUTINIB
Strength100MG
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2017
Marketing statusRX

Listed patents

PatentExpiresType
10167291July 2036product
9796721July 2036substance, product
11166951August 2035use U-4427
10272083January 2035use U-4109
11771696January 2035use U-3710
10239883July 2032use U-2666
9758524July 2032use U-2145
9290504July 2032substance, product
7459554November 2026substance

Regulatory exclusivity

CodeExpires
D-200February 2029
I-960January 2028
ODE-274November 2026

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.

CALQUENCE patent cliff — loss of exclusivity July 2036 | CliffBio