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Details for Patent: 5,824,642

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Patent 5,824,642 protects INCRELEX and is included in one NDA.

This patent has twenty-two patent family members in eleven countries.

Summary for Patent: 5,824,642

Title: Treatment of partial growth hormone insensitivity syndrome
Abstract:Methods for increasing the growth rate of a human patient having partial growth hormone insensitivity syndrome, but not Laron syndrome, are described. One such method comprises administering an effective dose of growth hormone, preferably growth hormone with a native human sequence, with or without an N-terminal methionine, to the patient. The patient is characterized as having a height of less than about -2 standard deviations below normal for age and sex, a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, a serum level of IGF-I that is below normal mean levels, and a serum level of growth hormone that is at least normal. In another such method, the same patient population is treated with an effective amount of IGF-I, given alone or in combination with an amount of growth hormone that is effective in combination with the IGF-I.
Inventor(s): Attie; Kenneth (San Francisco, CA), Carlsson; Lena M. S. (Goteborg, SE), Gesundheit; Neil (Los Altos, CA), Goddard; Audrey (San Francisco, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:08/468,580
Patent Claim Types:
see list of patent claims
Use;
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Ipsen Inc
INCRELEX
mecasermin recombinant
INJECTABLE;SUBCUTANEOUS021839-001Aug 30, 2005RXYes5,824,642<disabled>TREATMENT OF PRIMARY IGF-1 DEFICIENCY
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Non-Orange Book Patents for Patent: 5,824,642

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>
6,207,640 Treatment of partial growth hormone insensitivity syndrome<disabled in preview>
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International Patent Family for Patent: 5,824,642

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
Portugal754048Jan 30, 2002
World Intellectual Property Organization (WIPO)9527495Oct 19, 1995
European Patent Office0914148Aug 06, 2003
Canada2252560Dec 14, 2010
Japan2001510444Jul 31, 2001
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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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