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EDEX Drug Profile

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When do Edex patents expire, and what generic alternatives are available?

Edex is a drug marketed by Auxilium Pharms Llc and is included in one NDA.

The generic ingredient in EDEX is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

Summary for EDEX

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	71
Patent Applications:	2,251
Drug Prices:	Drug price information for EDEX
DailyMed Link:	EDEX at DailyMed

Pharmacology for EDEX

Ingredient-type	Prostaglandins
Drug Class	Prostaglandin Analog Prostaglandin E1 Agonist
Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Genitourinary Arterial Vasodilation Venous Vasodilation

Medical Subject Heading (MeSH) Categories for EDEX

Platelet Aggregation Inhibitors

Urological Agents

Vasodilator Agents

Synonyms for EDEX

(-)-Protaglandin E1

(11?,13E,15S)-11,15-Dihydroxy-9-oxo-prost-13-en-1-oic acid

(11alpha,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid

(11alpha,13E,15S)-11,15-Dihydroxy-9-oxoprost-13-enoic acid

(13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid

(13E)-(15S)-11alpha,15-Dihydroxy-9-oxoprost-13-enoate

(1R,2R,3R)-3-Hydroxy-2-((E)-(3S)-3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid

119314-69-1

11alpha,15alpha-Dihydroxy-9-oxo-13-trans-prostenoic acid

22299-37-2

3-Hydroxy-2-(3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid

50-83-9

50865-30-0

7-((1R,2R,3R)-3-hydroxy-2-((S,E)-3-hydroxyoct-1-en-1-yl)-5-oxocyclopentyl)heptanoic acid

7-[(1R,2R,3R)-3-hydroxy-2-[(E,3S)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]heptanoic acid

7-[(1r,3r)-3-Hydroxy-2-[(1e,3s)-3-Hydroxyoct-1-En-1-Yl]-5-Oxocyclopentyl]heptanoic Acid

7-[5-((1E)(3S)-3-hydroxyoct-1-enyl)(1R,4R,5R)-4-hydroxy-2-oxocyclopentyl]hepta noic acid

745-65-3

745P653

9-oxo-11R,15S-dihydroxy-13E-prostaenoic acid

AB0014134

AB00514004

AB00514004_09

AB00514004-06

AB00514004-08

AB2000131

AC-6095

AC1NQXHQ

AI3-62116

AKOS015961103

Alista

alprostadil

Alprostadil (JP15/USP/INN)

Alprostadil (JP17/USP/INN)

Alprostadil [USAN:USP:INN:BAN:JAN]

Alprostadil, European Pharmacopoeia (EP) Reference Standard

Alprostadil, meets USP testing specifications

Alprostadil, United States Pharmacopeia (USP) Reference Standard

Alprostadil(Caverject)

Alprostadilum

Alprostadilum [INN-Latin]

Alprox-TD

AS-16360

B2154

BC205461

BCP9000277

BDBM50101853

Befar

Befar (TN)

BG0025

BIDD:GT0747

BML1-F06

BPBio1_001293

BRD-K52459643-001-06-0

BSPBio_001175

BSPBio_001488

C04741

CAS-745-65-3

Caverject

Caverject (TN)

Caverject Impulse

CCG-101188

CHEBI:15544

CHEMBL495

CPD000112594

CS-1905

Cyclopentaneheptanoic acid, 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-, (-)-

Cyclopentaneheptanoic acid, 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-, l-

D00180

D0I4DQ

D0N2EF

DR001827

DSSTox_CID_2578

DSSTox_GSID_22578

DSSTox_RID_76640

DTXSID9022578

Edex (TN)

EINECS 212-017-2

EX-A1411

F5TD010360

FemLife

Femprox

GMVPRGQOIOIIMI-DWKJAMRDSA-N

GTPL1882

HEI-507

HMS1361K10

HMS1571K17

HMS1791K10

HMS1989K10

HMS2052L11

HMS2090L08

HMS2098K17

HMS3268I09

HMS3402K10

HMS3648O17

HY-B0131

IDI1_033958

K274

l-3-Hydroxy-2-(3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid

l-PGE1

l-Prostaglandin E1

Lipo-alprostadil

Lipoprost

Liprostin

LMFA03010134

LP069786

MFCD00077860

Minprog

MLS000758964

MLS001424250

MolPort-003-939-183

MR 256

MR-256

Muse

Muse (TN)

NC00438

NCGC00016535-01

NCGC00025234-02

NCGC00025234-03

NCGC00025234-04

NCGC00025234-05

NSC 165559

ONO 1608

PGE-1

PGE1

PGE1 Oligomer

PGE1;Prostaglandin E1

PGE1alpha

Prestwick2_001018

Prestwick3_001018

Prink (TN)

Promostan

Prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-, (11.alpha.,13E,15S)-

Prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-, (11alpha,13E,15S)-

Prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-, (11alpha,13E,15S)-, homopolymer

Prostaglandin E1

Prostaglandin E1, >=98% (HPLC), synthetic

Prostaglandin E1, >=99.0% (TLC)

Prostaglandin E1, powder, gamma-irradiated, BioXtra, suitable for cell culture

Prostaglandin E1, synthetic, powder, BioReagent, suitable for cell culture

Prostaglandin E1;Edex;Muse;Liprostin;Caverject

Prostaglandin-E1

Prostaglandine E

ProstaglandinE1

Prostandin

Prostavasin

Prostin VR

Prostin VR Pediatric

Prostin VR pediatric (TN)

Prostivas

RayVa

RP17688

RTECS HK5096000

s1508

SAM001246840

SAM001246845

SAM001247093

SCHEMBL33317

SMP2_000271

SMR000112594

SR-01000946253

SR-01000946253-1

ST50826271

Sugiran

SYN3025

Topiglan

Tox21_110482

U 10136

U-10,136

U-10136

UNII-F5TD010360

Vasaprostan

Viridal

Vitaros

Vitaros (TN)

W-104416

XPG

ZINC3813088

US Patents and Regulatory Information for EDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Auxilium Pharms Llc	EDEX	alprostadil	INJECTABLE;INJECTION	020649-001	Jun 12, 1997		DISCN	No	No
Auxilium Pharms Llc	EDEX	alprostadil	INJECTABLE;INJECTION	020649-007	Jul 30, 1998		RX	Yes	Yes
Auxilium Pharms Llc	EDEX	alprostadil	INJECTABLE;INJECTION	020649-003	Jun 12, 1997	AP	RX	Yes	No
Auxilium Pharms Llc	EDEX	alprostadil	INJECTABLE;INJECTION	020649-002	Jun 12, 1997	AP	RX	Yes	No
Auxilium Pharms Llc	EDEX	alprostadil	INJECTABLE;INJECTION	020649-005	Jul 30, 1998		RX	Yes	Yes
Auxilium Pharms Llc	EDEX	alprostadil	INJECTABLE;INJECTION	020649-004	Jun 12, 1997	AP	RX	Yes	Yes
Auxilium Pharms Llc	EDEX	alprostadil	INJECTABLE;INJECTION	020649-006	Jul 30, 1998		RX	Yes	Yes