small molecule

ESBRIET

PIRFENIDONE

Loss of exclusivityMarch 2037latest FDA-listed patent expiry
CompanyLEGACY PHARMA INC SEZC

Drug detail

Brand nameESBRIET
Active ingredientPIRFENIDONE
Strength534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJanuary 2017
Marketing statusDISCN

Listed patents

PatentExpiresType
10188637March 2037product
8778947August 2033use U-2045
7910610January 2030use U-2049
8084475January 2030use U-2054
8318780January 2030use U-2081
8754109January 2030use U-2053
8648098January 2030use U-2051
7816383January 2030use U-2042
8013002January 2030use U-2082
8592462April 2029use U-2059
7635707April 2029use U-2076
8609701April 2029use U-2066
7566729April 2029use U-2270
8383150May 2028product
8420674December 2027use U-2079
7767700December 2027use U-2080

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.

ESBRIET patent cliff — loss of exclusivity March 2037 | CliffBio