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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, Eurohlth Intl Sarl, 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)

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
Pharmacia And Upjohn
CAVERJECT IMPULSE
alprostadil
INJECTABLE;INJECTION021212-001Jun 11, 2002RXNo<disabled><disabled>
Auxilium Pharms Inc
EDEX
alprostadil
INJECTABLE;INJECTION020649-007Jul 30, 1998RXYes<disabled><disabled>
Pharmacia And Upjohn
CAVERJECT
alprostadil
INJECTABLE;INJECTION020379-003Jun 27, 1996RXNo<disabled><disabled>
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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;URETHRAL020700-003Nov 19, 19965,773,020<disabled>
Pharmacia And Upjohn
CAVERJECT IMPULSE
alprostadil
INJECTABLE;INJECTION021212-002Jun 11, 20025,501,673<disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-001Nov 19, 19965,474,535<disabled>
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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<disabled in preview>
5,843,961 Method and composition for treating erectile dysfunction<disabled in preview>
5,849,803 Method of treating erectile dysfunction with nitroglycerine<disabled in preview>
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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
Germany68907909<disabled in preview>
European Patent Office0432199<disabled in preview>
Norway301046<disabled in preview>
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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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