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Alprostadil - Generic Drug Details

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Alprostadil is the generic ingredient in six branded drugs marketed by Meda Pharms, Pharmacia And Upjohn, West-ward Pharms Int, Auxilium Pharms Inc, Pfizer, and Teva Pharms Usa, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-three patent family members in sixteen countries.

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

Summary for Generic Name: alprostadil

Tradenames:6
Patents:1
Applicants:6
NDAs:8
Drug Master File Entries: see list7
Suppliers / Packaging: see list5
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins)
Drug Prices:see low prices

Pharmacology for Ingredient: alprostadil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Auxilium Pharms Inc
EDEX
alprostadil
INJECTABLE;INJECTION020649-003Jun 12, 1997RXNo► subscribe► subscribe
Auxilium Pharms Inc
EDEX
alprostadil
INJECTABLE;INJECTION020649-004Jun 12, 1997RXYes► subscribe► subscribe
Auxilium Pharms Inc
EDEX
alprostadil
INJECTABLE;INJECTION020649-001Jun 12, 1997DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: alprostadil

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 19965,773,020► subscribe
Pharmacia And Upjohn
CAVERJECT IMPULSE
alprostadil
INJECTABLE;INJECTION021212-002Jun 11, 20024,968,299► subscribe
Pharmacia And Upjohn
CAVERJECT IMPULSE
alprostadil
INJECTABLE;INJECTION021212-001Jun 11, 20024,968,299► subscribe
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Non-Orange Book Patents for Generic Ingredient: alprostadil

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,942,512 Method and composition for treating erectile dysfunction► subscribe
5,843,961 Method and composition for treating erectile dysfunction► subscribe
5,849,803 Method of treating erectile dysfunction with nitroglycerine► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: alprostadil

Country Document Number Estimated Expiration
JapanH04501707► subscribe
World Intellectual Property Organization (WIPO)9002545► subscribe
European Patent Office0357581► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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