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Details for Generic Name: alprostadil

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Alprostadil is the generic ingredient in six branded drugs marketed by Eurohlth Intl Sarl, Teva Pharms Usa, Pfizer, Pharmacia And Upjohn, Auxilium Pharms Llc, and Meda Pharms, and is included in eight NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-seven patent family members in nineteen countries.

There are seven drug master file entries for alprostadil. Four suppliers are listed for this compound.

Summary for Generic Name: alprostadil

Tradenames:6
Patents:3
Applicants:6
NDAs:8
Drug Master File Entries: see list7
Suppliers / Packaging: see list19
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins)

Pharmacology for Ingredient: alprostadil

Clinical Trials for: alprostadil

Alprostadil in Maculopathy Study (AIMS)
Status: Terminated Condition: Macular Degeneration

The Use of Prostaglandin E1 in Head and Neck Microsurgery
Status: Recruiting Condition: Microsurgery; Head and Neck; Prostaglandin E1; Thrombosis; Complications

Prostaglandin E1 in Outpatients With Intermittent Claudication
Status: Completed Condition: Stage II Peripheral Arterial Occlusive Disease; Intermittent Claudication Fontaine Stage II PAOD

Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Status: Completed Condition: Peripheral Arterial Occlusive Disease

Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention
Status: Not yet recruiting Condition: Prostaglandin E1; Percutaneous Coronary Intervention

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
CAVERJECT
alprostadil
INJECTABLE;INJECTION020379-002Jul 6, 1995RXYes5,741,523<disabled> <disabled>
Pfizer
CAVERJECT
alprostadil
INJECTABLE;INJECTION020755-003Oct 1, 1997DISCNNo<disabled><disabled>
Auxilium Pharms Llc
EDEX
alprostadil
INJECTABLE;INJECTION020649-002Jun 12, 1997RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: alprostadil

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 19965,474,535<disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-001Nov 19, 19965,242,391<disabled>
Pharmacia And Upjohn
CAVERJECT
alprostadil
INJECTABLE;INJECTION020379-002Jul 6, 19955,741,523<disabled>
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International Patent Family for Ingredient: alprostadil

Country Document Number Publication Date
Germany68907909Dec 23, 1993
European Patent Office0357581Mar 07, 1990
Denmark175560Dec 06, 2004
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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