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 75MG BASE
Dosage formCAPSULE, DELAYED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalApril 2013
Marketing statusRX

Listed patents

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

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