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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

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
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
INJECTABLE;INJECTION020379-001Jul 6, 1995RXNo5,741,523<disabled> <disabled>
Pharmacia And Upjohn
INJECTABLE;INJECTION020379-004May 19, 1997RXYes5,741,523<disabled> <disabled>
Auxilium Pharms Llc
INJECTABLE;INJECTION020649-006Jul 30, 1998RXYes<disabled><disabled>
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International Patent Family for Ingredient: alprostadil

Country Document Number Publication Date
Germany69433044Sep 18, 2003
South Africa8906681Jun 27, 1990
European Patent Office0725642Dec 01, 1999
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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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