small molecule

PROCYSBI

CYSTEAMINE BITARTRATE

Loss of exclusivityFebruary 2037latest FDA-listed patent expiry
CompanyHORIZON THERAPEUTICS USA INC

Drug detail

Brand namePROCYSBI
Active ingredientCYSTEAMINE BITARTRATE
StrengthEQ 300MG BASE/PACKET
Dosage formGRANULE, DELAYED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2020
Marketing statusRX

Listed patents

PatentExpiresType
10905662*PEDFebruary 2037
10328037*PEDFebruary 2037
10143665*PEDFebruary 2037
10548859*PEDFebruary 2037
10143665August 2036use U-1399
10548859August 2036use U-1399
10905662August 2036use U-1399
10328037August 2036use U-1399
9233077*PEDDecember 2034
9173851*PEDDecember 2034
9233077June 2034product
9173851June 2034product
8026284*PEDMarch 2028
8026284September 2027use U-1399
9925157*PEDJuly 2027
9192590*PEDJuly 2027
9198882*PEDJuly 2027
9925158*PEDJuly 2027
9925156*PEDJuly 2027
9925157January 2027product
9925156January 2027product
9198882January 2027use U-1399
9192590January 2027use U-1399
9925158January 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.

PROCYSBI patent cliff — loss of exclusivity February 2037 | CliffBio