Viewing data from:

EDEX

NDA

ALPROSTADIL | N020649 | ENDO OPERATIONS LTD

7 strengths0 unique patents0 unique exclusivities

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

32 trials from ClinicalTrials.gov — 1 recruiting, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure NCT00610051	Phase 3	Not Yet Recruiting	Biopeutics Co., Ltd	600	2026-10 → 2030-12
Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP NCT03296670	Phase 4	Completed	RenJi Hospital	57	2015-08-01 → 2017-08-31
Topical Alprostadil for Female Sexual Arousal Disorder NCT00324948	Phase 2	Completed	VIVUS LLC	300	2004-09 → 2006-11
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis NCT02228850	Phase 2	Completed	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)	35	2014-11 → 2015-12
Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension NCT00314548	N/A	Completed	Aga Khan University	67	2006-05 → 2009-07
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer NCT00080808	Phase 2	Completed	M.D. Anderson Cancer Center	111	2001-08 → 2009-07
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV NCT00596752	Phase 4	Completed	UCB BIOSCIENCES GmbH	840	2004-03 → 2013-07
Extracorporeal Shockwave Therapy in the Treatment for Erectile Dysfunction in Male Renal Transplant Recipients NCT02412345	N/A	Completed	University of Sao Paulo	20	2015-01 → 2018-05-01
Prostaglandin E1 in Outpatients With Intermittent Claudication NCT01263925	Phase 3	Completed	UCB Pharma	561	2001-04 → 2011-04
The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers NCT02889822	Phase 1	Completed	Guangzhou Yipinhong Pharmaceutical CO.,LTD	44	2010-03 → 2010-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$234.55

per ea

Lowest NADAC/Unit

$182.92

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52244002002EDEX 20 MCG CARTRIDGE 2-PK KIT	$234.55	EA	Brand	—	2026-06-17
52244001002EDEX 10 MCG CARTRIDGE 2-PK KIT	$182.92	EA	Brand	—	2026-02-18

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$73.29

Highest Price

$705.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52244-0010-02EDEX 10MMCG CARTRIDGE	$155.22	FSS	Endo USA, Inc.	04/30/2026
52244-0010-02EDEX 10MMCG CARTRIDGE	$73.29	Big4	Endo USA, Inc.	04/30/2026
52244-0010-06EDEX 10MCG CARTRIDGE	$400.12	FSS	Endo USA, Inc.	04/30/2026
52244-0010-06EDEX 10MCG CARTRIDGE	$219.86	Big4	Endo USA, Inc.	04/30/2026
52244-0020-02EDEX 20MCG CARTRIDGE	$200.53	FSS	Endo USA, Inc.	04/30/2026
52244-0020-02EDEX 20MCG CARTRIDGE	$94.76	Big4	Endo USA, Inc.	04/30/2026

Showing 6 of 12 NDCs.

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

API Supply Chain6 active DMFs3 inactive

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

CAYMAN PHARMA SROALPROSTADIL

DMF 96881992

EUROAPI HUNGARY LTDALPROSTADIL

DMF 109481994

EVERLIGHT CHEMICAL INDUSTRIAL CORPALPROSTADIL

DMF 212332008

MARUISHI PHARMACEUTICAL CO LTDALPROSTADIL ALFADEX

DMF 271302013

TIEN (TIANJIN) PHARMACEUTICAL CO LTDALPROSTADIL

DMF 342392020

EUROAPI HUNGARY LTDALPROSTADIL ALFADEX

DMF 432462025

ONO PHARMACEUTICAL CO LTDInactiveALPROSTADIL ALFADEX I.V.

DMF 104151993

NISSAN CHEMICAL INDUSTRIES LTDInactiveALPROSTADIL

DMF 118451996

CASCADE BIOCHEMICAL LTDInactiveALPROSTADIL

DMF 125691997

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 11, 2015	SUPPL -23	View Letter (PDF)
Jun 12, 2006	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 0.005MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 12, 1997

No patent or exclusivity listings for this strength.

#002 — 0.01MG/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 12, 1997

#003 — 0.02MG/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 12, 1997

#004 — 0.04MG/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 12, 1997

#005 — 0.01MG/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 30, 1998

#006 — 0.02MG/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 30, 1998

#007 — 0.04MG/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 30, 1998