CliffBio
small molecule

ORENITRAM

TREPROSTINIL DIOLAMINE

Loss of exclusivityAugust 2031latest FDA-listed patent expiry
CompanyUnited Laboratories →View the full company profile on CliffBio

Drug detail

Brand nameORENITRAM
Active ingredientTREPROSTINIL DIOLAMINE
StrengthEQ 2.5MG BASE
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2013
Marketing statusRX

Listed patents

PatentExpiresType
8747897August 2031product
8349892January 2031product
8410169February 2030product
8497393December 2028substance
9593066December 2028substance
11723887December 2028substance
7417070July 2026substance
9393203April 2026product

Regulatory exclusivity

CodeExpires
ODE-272October 2026

More from United Laboratories

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.

ORENITRAM patent cliff — loss of exclusivity August 2031 | CliffBio