Treprostinil Diolamine

Treats pulmonary arterial hypertension (PAH) (WHO Group 1). Sold as Orenitram. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Treprostinil Diolamine (sold as Orenitram), first approved Dec 20, 2013, with 2 new uses approved and 0 published complete response letters.

First approved: Dec 20, 2013
Applications: 1
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $278M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Orenitram ER	Part D	$277M	+20%	1,398
Orenitram Month 3 Titration Kt	Part D	$404K	+1%	62
Orenitram Month 2 Titration Kt	Part D	$329K	+12%	81
Orenitram Month 1 Titration Kt	Part D	$183K	+19%	114

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
ADAPT - A Patient Registry of the Real-world Use of Orenitram®Pulmonary Arterial Hypertension · United Therapeutics	—	Active, not recruiting	Feb 7, 2017

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 20, 2013	OrenitramNDA 203496 · New dosage form	United Therap	7	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA