small molecule

BRUKINSA

ZANUBRUTINIB

Loss of exclusivityJanuary 2043latest FDA-listed patent expiry
CompanyBEONE MEDICINES USA INC

Drug detail

Brand nameBRUKINSA
Active ingredientZANUBRUTINIB
Strength80MG
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2019
Marketing statusDISCN

Listed patents

PatentExpiresType
11896596January 2043use U-3875
11786531January 2043use U-3720
11911386January 2043use U-3875
11701357June 2039use U-3860
11591340August 2037use U-3728
10927117August 2037substance, product
11884674August 2037use U-3860
11851437August 2037substance, product
11970500August 2037use U-2145
11142528April 2034product
10570139April 2034use U-2145
9447106April 2034substance, product

Regulatory exclusivity

CodeExpires
ODE-467March 2031
ODE-274January 2030
ODE-370September 2028
ODE-371August 2028
I-936March 2027
ODE-276November 2026
I-817January 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.

BRUKINSA patent cliff — loss of exclusivity January 2043 | CliffBio