small molecule

XOFLUZA

BALOXAVIR MARBOXIL

Loss of exclusivityOctober 2039latest FDA-listed patent expiry
CompanyGenentechSee this company's full patent-cliff portfolio

Drug detail

Brand nameXOFLUZA
Active ingredientBALOXAVIR MARBOXIL
Strength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2018
Marketing statusDISCN

Listed patents

PatentExpiresType
12064438October 2039product
11261198September 2038product
11306106August 2037use U-3000
10759814August 2037substance, product
10633397April 2036use U-3000
10392406April 2036substance
8987441October 2032substance, product
8927710May 2031product
9815835June 2030product

Regulatory exclusivity

CodeExpires
M-187December 2027

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.

XOFLUZA patent cliff — loss of exclusivity October 2039 | CliffBio