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AURLUMYN

NDA

ILOPROST | N217933 | BTG INTERNATIONAL INC

1 strength2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Active (2)TodayExclusivity

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Today

12409183

Jul. 18, 2044

12409184

Aug. 6, 2041

Feb. 13, 2027

ODE-465

Feb. 13, 2031

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Actelion Pharmaceuticals Ltd. - Citizen Petition FDA-2013-P-0424 · 3 docket documents Actelion Pharmaceuticals Ltd. filed this citizen petition under 21 USC 355 and 21 CFR 10.30 requesting that the FDA not approve any abbreviated new drug application (ANDA) referencing Ventavis (iloprost) inhalation solution unless the proposed generic contains the same ratio of iloprost diastereoiso	505(q)	2013-04-24	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

56 trials from ClinicalTrials.gov, 35 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)NCT01718288	Phase 4	Completed	Fadoi Foundation, Italy	150	2006-11 → 2012-04
ILOPROST in Septic Shock With Persistent Microperfusion Defects (I-MICRO)NCT03788837	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris	240	2019-07-03 → 2024-01-18
Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD)NCT00561223	N/A	Completed	University of Oklahoma	10	2006-11 → 2012-10-31
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure NCT04123444	Phase 2/3	Completed	Jakob Stensballe, MD, PhD	279	2019-10-30 → 2022-06-28
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)NCT04040322	Phase 3	Completed	Civi Biopharma, Inc.	198	2019-10-14 → 2021-06-09
Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation NCT02784899	N/A	Completed	Yonsei University	40	2015-10-08 → 2017-06-30
Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients NCT01941225	Phase 2	Completed	Louisiana State University Health Sciences Center in New Orleans	24	2013-09 → 2016-11
Iloprost Power 15 in Pulmonary Arterial Hypertension NCT00709956	Phase 3	Completed	Actelion	64	2008-07 → 2009-08
Iloprost in High Risk Cardiac Surgical Patients NCT00927654	Phase 3	Completed	Ludwig-Maximilians - University of Munich	253	2009-06 → 2012-03
Infusion of Prostacyclin vs Placebo for 72-hours in Trauma Patients With Haemorrhagic Shock Suffering From Organ Failure NCT03903939	Phase 2	Completed	Pär Johansson	228	2019-05-22 → 2021-11-14

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$4116.98

Highest Price

$5417.09

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50633-0340-01AURLUMYN 100MCG/ML INJ,SOLN	$5417.09	FSS	BTG International, Inc.	07/31/2026
50633-0340-01AURLUMYN 100MCG/ML INJ,SOLN	$4116.98	Big4	BTG International, Inc.	07/31/2026

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

API Supply Chain5 active DMFs2 inactive

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

BAYER AGILOPROST

DMF 171702004

EUROAPI HUNGARY LTDILOPROST

DMF 331532018

MSN LABORATORIES PRIVATE LTDILOPROST

DMF 346952020

YS LIFE SCIENCE CO LTDILOPROST

DMF 360222021

CHIROGATE INTERNATIONAL INCILOPROST

DMF 411862025

SCHERING AGInactiveILOPROST

DMF 91401991

BAYER SCHERING PHARMA AGInactiveILOPROST B-CYCLODEXRIN CLATHRATE

DMF 117061995

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 20, 2024	SUPPL -1	View Letter (PDF)
Feb 14, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MCG/ML (100MCG/ML)

RLD

2 patents2 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 13, 2024

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12409183	Jul 18, 2044	—	—	—		—
12409184	Aug 6, 2041	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NP	Feb 13, 2027	< 1 year
ODE-465	Feb 13, 2031	Active