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Profile for Tradename: NORDITROPIN

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Norditropin is a drug marketed by Novo Nordisk Inc and is included in two NDAs. It is available from two suppliers. There are fourteen patents protecting this drug.

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

The generic ingredient in NORDITROPIN is somatropin recombinant. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.

Summary for Tradename: NORDITROPIN

Patents:14
Applicants:1
NDAs:2
Suppliers / Packagers: see list11

Pharmacology for Tradename: NORDITROPIN

Clinical Trials for: NORDITROPIN

American Norditropin Studies - Registry of Growth Hormone (GH) Patients
Status: Suspended Condition: Growth Hormone Deficiency

Observational Prospective Study on Patients Treated With Norditropin®
Status: Enrolling by invitation Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Adult Growth Hormone Deficiency; Genetic Disorder; Turner Syndrome; Foetal Growth Problem; Small for Gestational Age; Chronic Kidney Disease; Chronic Renal Insufficiency; Noonan Syndrome

Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
Status: Completed Condition: Growth Hormone Deficiency

Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
Status: Terminated Condition: Growth Hormone Deficiency (GHD)

Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments
Status: Recruiting Condition: Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy

A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
Status: Completed Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency

An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
Status: Active, not recruiting Condition: Adult Growth Hormone Deficiency

Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
Status: Completed Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Foetal Growth Problem; Small for Gestational Age; Genetic Disorder; Turner Syndrome; Chronic Kidney Disease; Chronic Renal Insufficiency; Delivery Systems

Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Status: Completed Condition: Turner's Syndrome; Human Growth Hormone Deficiency

Effects of Short-term Growth Hormone in HIV-infected Patients
Status: Completed Condition: HIV Lipodystrophy

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
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-011Jan 23, 2015RXNo8,841,252<disabled>Y <disabled>
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-010Mar 1, 2010RXNo9,108,002<disabled>Y <disabled>
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-004Oct 1, 2004DISCNNo5,849,700<disabled> <disabled>
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Expired Patents for Tradename: NORDITROPIN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION021148-003Jun 20, 20005,849,704<disabled>
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION019721-001May 8, 19955,633,352<disabled>
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION021148-003Jun 20, 20005,849,700<disabled>
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International Patent Family for Tradename: NORDITROPIN

Country Document Number Publication Date
Romania111990Apr 30, 1997
Spain2291264Mar 01, 2008
Germany69233704Sep 13, 2007
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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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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