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Treprostinil Diolamine

Sold as ORENITRAM · given by oral

Five to ten years until it comes off patent
5.0 yr
Until anyone may copy it
Protection runs to 2031-08-11
1
Trials running now
9 registered in total
Phase 3
Furthest stage reached
large trials measuring benefit
2
Organisations running trials
lead sponsors on record
01

Who owns it, and until when

United Therapeutics Corp
Approval holder
the only company permitted to sell it today
2031-08
Last patent expires
latest patent filed against this product
2026-10
FDA exclusivity ends
a separate protection granted at approval

Whichever date falls later is when other manufacturers may apply to sell copies. Price typically falls steeply within a year of that point, and with it any company's ability to recover the cost of new research on the molecule. That is when it becomes a candidate for the ledger on the first tab.

02

What it is being tested for

Pulmonary Arterial HypertensionPulmonary HypertensionHealthy
03

Who is paying for the research

United Therapeutics
Company
8
Mardi Gomberg -Maitland MD, MSc
University or hospital
1

Who funds the trials matters after protection lapses. Company-funded work usually stops once exclusivity ends; university, hospital and government-funded work does not, and is the research most likely to continue on this molecule afterwards.

04

The trials themselves

NCT04882774Phase 22023 · withdrawn
Telemonitoring to Treat Group 2 Pulmonary Hy

Expiry dates are what the patent holder has filed; litigation, paediatric extensions and settlements routinely move them, so read these as the earliest plausible date rather than a schedule. Not medical advice.

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