small molecule

SUBSYS

FENTANYL

Loss of exclusivityApril 2030latest FDA-listed patent expiry
CompanyBTCP PHARMA LLC

Drug detail

Brand nameSUBSYS
Active ingredientFENTANYL
Strength0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formSPRAY
RouteSUBLINGUAL
ModalitySmall molecule
FDA approvalJanuary 2012
Marketing statusDISCN

Listed patents

PatentExpiresType
8486973April 2030use U-55
8486972April 2030product
8835460January 2027product
10610523January 2027product
9241935January 2027product
9642844January 2027product
9642797January 2027product
10016403January 2027product
9289387January 2027product

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.

SUBSYS patent cliff — loss of exclusivity April 2030 | CliffBio