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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
Auxilium Pharms Llc
EDEX
alprostadil
INJECTABLE;INJECTION020649-005Jul 30, 1998RXYes<disabled><disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 1996RXNo5,886,039<disabled>Y<disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-001Nov 19, 1996RXNo5,886,039<disabled>Y<disabled>
Pharmacia And Upjohn
CAVERJECT IMPULSE
alprostadil
INJECTABLE;INJECTION021212-002Jun 11, 2002RXNo5,716,338<disabled>Y<disabled>
Auxilium Pharms Llc
EDEX
alprostadil
INJECTABLE;INJECTION020649-004Jun 12, 1997RXYes<disabled><disabled>
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International Patent Family for Ingredient: alprostadil

Country Document Number Publication Date
Australia638414Jul 01, 1993
European Patent Office0432199Jul 28, 1993
World Intellectual Property Organization (WIPO)9511683May 04, 1995
Norway309126Dec 18, 2000
Germany69426644Jun 07, 2001
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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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