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Profile for Tradename: INCRELEX

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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 are two patents protecting this drug.

This drug has fifty-one patent family members in seventeen 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:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Clinical Trials for: INCRELEX

IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
Status: Terminated Condition: Primary Insulin-like Growth Factor-1 Deficiency

rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
Status: Terminated Condition: Insulin-like Growth Factor-1 Deficiency

Effect of Increlex® on Children With Crohn Disease
Status: Terminated Condition: Crohn Disease

European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry
Status: Recruiting Condition: IGF1 Deficiency

Long-Term Treatment With rhIGF-1 in GHIS
Status: Completed Condition: Growth Hormone Insensitivity Syndrome

Treatment of Rett Syndrome With rhIGF-1 (Mecasermin [rDNA]Injection)
Status: Completed Condition: Rett Syndrome

IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency
Status: Not yet recruiting Condition: Short Stature

Increlex Treatment of Children With Chronic Liver Disease and Short Stature
Status: Not yet recruiting Condition: Growth Failure; Chronic Liver Disease

Treatment of Rett Syndrome With Recombinant Human IGF-1
Status: Recruiting Condition: Rett Syndrome

Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)
Status: Completed Condition: Diabetes

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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, 2005RXYes5,824,642<disabled> <disabled>
Ipsen Inc
INCRELEX
mecasermin recombinant
INJECTABLE;SUBCUTANEOUS021839-001Aug 30, 2005RXYes5,681,814<disabled>Y <disabled>
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Expired Patents for Tradename: INCRELEX

These historical archives are available as an add-on to one-year subscriptions

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
5,646,113 Treatment of partial growth hormone insensitivity syndrome<disabled in preview>
5,849,580 Nucleic acid encoding a NF-.kappa.B activation regulatory protein, I.kappa.B.beta.<disabled in preview>
5,597,898 NF-.kappa.B activation regulatory protein, I.kappa.B-.beta.<disabled in preview>
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International Patent Family for Tradename: INCRELEX

Country Document Number Publication Date
Denmark0536226Feb 10, 1997
Japan2961708Oct 12, 1999
JapanH05507278Oct 21, 1993
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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.

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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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