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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: see list4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins)

Pharmacology for Ingredient: alprostadil

Clinical Trials for: alprostadil

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;INJECTION020649-007Jul 30, 1998RXYes<disabled><disabled>
Pfizer
CAVERJECT
alprostadil
INJECTABLE;INJECTION020755-002Oct 1, 1997DISCNNo<disabled><disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-002Nov 19, 1996RXNo5,886,039<disabled>Y<disabled>
Auxilium Pharms Llc
EDEX
alprostadil
INJECTABLE;INJECTION020649-004Jun 12, 1997RXYes<disabled><disabled>
Auxilium Pharms Llc
EDEX
alprostadil
INJECTABLE;INJECTION020649-006Jul 30, 1998RXYes<disabled><disabled>
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International Patent Family for Ingredient: alprostadil

Country Document Number Publication Date
Greece90300093Sep 27, 1991
Australia4199489Apr 02, 1990
European Patent Office0947209Aug 13, 2003
Australia683947Nov 27, 1997
New Zealand274948Feb 24, 1997
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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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