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MUSE Drug Profile

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Muse is a drug marketed by Meda Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

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

The generic ingredient in MUSE is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

Summary for Tradename: MUSE

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Clinical Trials for: MUSE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-001Nov 19, 1996RXYes5,886,039<disabled>Y <disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996RXYes5,886,039<disabled>Y <disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-002Nov 19, 1996RXYes5,886,039<disabled>Y <disabled>
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Expired Patents for Tradename: MUSE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 19964,801,587<disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 19965,886,039<disabled>
Meda Pharms
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-002Nov 19, 19965,474,535<disabled>
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Non-Orange Book Patents for Tradename: MUSE

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
5,843,961 Method and composition for treating erectile dysfunction<disabled in preview>
5,942,512 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 Tradename: MUSE

Country Document Number Estimated Expiration
Canada1335346<disabled in preview>
European Patent Office0432199<disabled in preview>
Denmark36491<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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