small molecule

REXULTI

BREXPIPRAZOLE

Loss of exclusivityApril 2033latest FDA-listed patent expiry
CompanyOtsuka PharmaceuticalView the full company profile on CliffBio

Drug detail

Brand nameREXULTI
Active ingredientBREXPIPRAZOLE
Strength3MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJuly 2015
Marketing statusRX

Listed patents

PatentExpiresType
10307419*PEDApril 2033
10307419October 2032product
RE48059*PEDJune 2029
RE48059December 2028substance
9839637*PEDOctober 2026
8618109*PEDOctober 2026
7888362*PEDOctober 2026
8349840*PEDOctober 2026
8618109April 2026use U-3281
7888362April 2026substance
9839637April 2026product
8349840April 2026product

Regulatory exclusivity

CodeExpires
M-315May 2028
PEDNovember 2027
M-14May 2027
PEDNovember 2026
I-913May 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.

REXULTI patent cliff — loss of exclusivity April 2033 | CliffBio