Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00006	8497393	IPR	SteadyMed Ltd. et al.	Final Written Decision	2015-10-02	—
IPR2020-00769	9593066	IPR	Liquidia Technologies, Inc.	Institution Denied	2020-03-30	—
IPR2020-00770	9604901	IPR	Liquidia Technolgies, Inc.	Final Written Decision	2020-03-30	2024-08-20

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
United Therapeutics Corporation et al v. ANI Pharmaceuticals, Inc. 1:2021cv00489 12 patentsANDA 215667treprostinil	D. Del.	2021-04-01	Terminated 2022-05-26	—
UNITED THERAPEUTICS CORPORATION et al v. ACTAVIS LABORATORIES FL, INC. 3:2016cv01816 9 patentsANDA 208906treprostinil	D.N.J.	2016-03-31	Terminated 2018-02-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Orenitram ER (2023)

Total Spending

$182.5M

Total Claims

16,074

Beneficiaries

1,011

Avg Cost/Unit

$100.47

Spending Trend

$116.1M(2019)→$150.7M(2020)→$163.1M(2021)→$162.2M(2022)→$155K(2023)→$137K(2023)→$88K(2023)→$182.5M(2023)

YoY Change:+17.5%

5yr CAGR:+11.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

EVERLIGHT CHEMICAL INDUSTRIAL CORPTREPROSTINIL DIOLAMINE

DMF 305352016

SS PHARMA LLCTREPROSTINIL DIOLAMINE

DMF 313852017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 12, 2025	SUPPL -13	View Letter (PDF)
Oct 22, 2019	SUPPL -11	View Letter (PDF)
Jun 16, 2017	SUPPL -7	View Letter (PDF)
Jan 27, 2017	SUPPL -6	View Letter (PDF)
Jan 28, 2016	SUPPL -2	View Letter (PDF)
Oct 8, 2014	SUPPL -1	View Letter (PDF)
Dec 24, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 0.125MG BASE

RLD

8 patents1 exclusivity▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 20, 2013

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7417070	Jul 30, 2026	—	Yes	—	—	—
8349892	Jan 22, 2031	—	—	Yes	—	—
8410169	Feb 13, 2030	—	—	Yes	—	—
8747897	Aug 11, 2031	—	—	Yes		—
9393203	Apr 27, 2026	—	—	Yes		—
9593066	Dec 15, 2028	—	Yes	—	—	—
9604901	Dec 15, 2028	—	Yes	—	—	Delisted
11723887	Dec 15, 2028	—	Yes	—	—	—

Exclusivities (1)

Code	Date	Status
ODE-272	Oct 18, 2026	< 1 year

#002 — EQ 0.25MG BASE

RLD

8 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 20, 2013

#003 — EQ 1MG BASE

RLD

8 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 20, 2013

#004 — EQ 2.5MG BASE

RLD

8 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 20, 2013

#005 — EQ 5MG BASE

RLD

8 patents1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 7, 2016