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VELETRI

NDA

EPOPROSTENOL SODIUM | N022260 | ACTELION PHARMACEUTICALS US INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (2)Today

2027

Today

8318802

Mar. 15, 2027

8598227

Feb. 2, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Actelion Pharmaceuticals Ltd. v. Gland Pharma Limited 1:2024cv00434	D. Del.	2024-04-05	Terminated 2025-10-21	—
Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. 1:2020cv00110 2 patentsANDA 213913epoprostenol sodium	N.D. W. Va.	2020-06-09	Terminated 2024-03-18	—
ACTELION PHARMACEUTICALS LTD. v. SUN PHARMACEUTICAL INDUSTRIES, INC. et al 3:2017cv05015 1 patentANDA 210473epoprostenol sodium	D.N.J.	2017-07-07	Terminated 2019-08-21	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

11 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Epoprostenol in Pulmonary Embolism NCT01014156	Phase 4	Completed	Universitair Ziekenhuis Brussel	14	2004-01 → 2006-06
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension NCT01470144	Phase 3	Completed	Actelion	41	2011-06-01 → 2015-07-01
Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV)NCT02748265	Phase 4	Completed	University Health Network, Toronto	8	2016-03 → 2018-12-31
Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension NCT01431716	Phase 3	Completed	Actelion	42	2011-03 → 2012-07
Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement NCT01717209	Phase 4	Completed	Stanford University	14	2012-10 → 2013-10
Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension NCT00004754	Phase 4	Completed	National Center for Research Resources (NCRR)	—	1993-08
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)NCT02251041	Phase 2	Completed	Universitaire Ziekenhuizen KU Leuven	143	2014-09 → 2019-08
Prostacyclin's Effect on Platelet Responsiveness NCT00890214	Phase 4	Completed	Catholic University of the Sacred Heart	23	2007-09 → 2008-05
Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury NCT01363583	Phase 1	Completed	Umeå University	48	2002-01 → 2005-12
Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)NCT01462565	Phase 4	Completed	GlaxoSmithKline	16	2011-11-01 → 2012-11-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$19.49

Highest Price

$53.43

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66215-0402-01VELETRI 1.5MG/VI INJ	$53.43	FSS	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0402-01VELETRI 1.5MG/VI INJ	$39.21	Big4	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0403-01VELETRI 0.5MG/VI INJ	$26.72	FSS	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029
66215-0403-01VELETRI 0.5MG/VI INJ	$19.49	Big4	Actelion Pharmaceuticals, U.S. Inc.	07/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Veletri (2024)

Total Spending

$606K

Total Claims

223

Beneficiaries

Avg Cost/Unit

$52.49

Spending Trend

$493K(2019)→$146K(2020)→$546K(2021)→$743K(2022)→$760K(2023)→$606K(2024)

YoY Change:-0.6%

5yr CAGR:+1.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs3 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

PHARMACIA AND UPJOHN SUB PFIZER INCEPOPROSTENOL SODIUM (U-53,217A)

DMF 60651985

CAYMAN PHARMA SROEPOPROSTENOL SODIUM

DMF 215842008

MSN LABORATORIES PRIVATE LTDEPOPROSTENOL SODIUM [ROUTE CODE - ED]

DMF 274202013

SUN PHARMACEUTICAL INDUSTRIES LTDEPOPROSTENOL SODIUM

DMF 302632017

JOHNSON MATTHEY PHARMA SERVICESInactiveEPOPROSTENOL SODIUM

DMF 180192005

SAI LIFE SCIENCES LTDInactiveEPOPROSTENOL SODIUM, NON-STERILE

DMF 199712006

EVERLIGHT CHEMICAL INDUSTRIAL CORPInactiveEPOPROSTENOL SODIUM

DMF 213112008

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 23, 2020	SUPPL -12	View Letter (PDF)
Dec 20, 2018	SUPPL -10	View Letter (PDF)
Apr 1, 2011	SUPPL -4	View Letter (PDF)
Aug 30, 2010	SUPPL -2	View Letter (PDF)
Jul 1, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1.5MG BASE/VIAL

RLDAP2

2 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 27, 2008

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8318802	Mar 15, 2027	—	—	Yes	—	—
8598227	Feb 2, 2027	—	—	—	—	—

#002 — EQ 0.5MG BASE/VIAL

RLDAP2

2 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 28, 2012