small molecule

REXULTI

BREXPIPRAZOLE

Loss of exclusivityApril 2033latest FDA-listed patent expiry
CompanyOtsuka PharmaceuticalSee this company's full patent-cliff portfolio

Drug detail

Brand nameREXULTI
Active ingredientBREXPIPRAZOLE
Strength2MG
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
8349840*PEDOctober 2026
8349840April 2026product
9839637April 2026product
8618109April 2026use U-3281

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