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INCRELEX Drug Profile

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Increlex is a drug marketed by Ipsen Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

This drug has twenty-nine patent family members in fifteen countries.

The generic ingredient in INCRELEX is mecasermin recombinant. One supplier is listed for this compound. Additional details are available on the mecasermin recombinant profile page.

Summary for Tradename: INCRELEX

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

Clinical Trials for: INCRELEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipsen Inc
INCRELEX
mecasermin recombinant
INJECTABLE;SUBCUTANEOUS021839-001Aug 30, 2005RXYes5,681,814<disabled>Y <disabled>
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Expired Patents for Tradename: INCRELEX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipsen Inc
INCRELEX
mecasermin recombinant
INJECTABLE;SUBCUTANEOUS021839-001Aug 30, 20055,824,642<disabled>
Ipsen Inc
INCRELEX
mecasermin recombinant
INJECTABLE;SUBCUTANEOUS021839-001Aug 30, 20056,207,640<disabled>
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Non-Orange Book Patents for Tradename: INCRELEX

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
5,597,802 Method of formulating IGF-I with growth hormone<disabled in preview>
5,126,324 Method of enhancing growth in patients using combination therapy<disabled in preview>
5,597,797 Method for treatment or prevention of obesity<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: INCRELEX

Country Document Number Estimated Expiration
Canada2145501<disabled in preview>
JapanH11500312<disabled in preview>
Moldova, Republic of960245<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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