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Details for Generic Name: mecasermin recombinant

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Mecasermin recombinant is the generic ingredient in one branded drug marketed by Ipsen Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-one patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for Generic Name: mecasermin recombinant

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list1

Clinical Trials for: mecasermin recombinant

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

Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Status: Completed Condition: Insulin-Like Growth Factor-1 Deficiency; Growth Disorders

Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Status: Completed Condition: Disorder of Bone Density and Structure, Unspecified

Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Status: Completed Condition: Growth Disorders; Insulin-Like Growth Factor-1 Deficiency

Effects of IGF-I in HIV Metabolic Disease
Status: Terminated Condition: HIV Lipodystrophy

Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
Status: Terminated Condition: Noonan Syndrome

Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
Status: Terminated Condition: Growth Disorders

IGF-1 Therapy in Patients With Cystic Fibrosis
Status: Terminated Condition: Cystic Fibrosis

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

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors
Status: Terminated Condition: Growth Hormone Deficiency

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, 2005RXYes5,681,814<disabled>Y<disabled>
Ipsen Inc
INCRELEX
mecasermin recombinant
INJECTABLE;SUBCUTANEOUS021839-001Aug 30, 2005RXYes5,824,642<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: mecasermin recombinant

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>
5,849,580 Nucleic acid encoding a NF-.kappa.B activation regulatory protein, I.kappa.B.beta.<disabled in preview>
5,646,113 Treatment of partial growth hormone insensitivity syndrome<disabled in preview>
5,597,898 NF-.kappa.B activation regulatory protein, I.kappa.B-.beta.<disabled in preview>
5,126,324 Method of enhancing growth in patients using combination therapy<disabled in preview>
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International Patent Family for Ingredient: mecasermin recombinant

Country Document Number Publication Date
Spain2160704Nov 16, 2001
Austria143267Oct 15, 1996
Canada2252560Dec 14, 2010
Germany69121715Feb 06, 1997
JapanH09509430Sep 22, 1997
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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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