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Details for Generic Name: somatropin recombinant

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Somatropin recombinant is the generic ingredient in twenty branded drugs marketed by Emergent, Ferring, Pharmacia And Upjohn, Lilly, Novo Nordisk Inc, Genentech, Sandoz, Emd Serono, and Lg Life, and is included in fourteen NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and eigthy-eight patent family members in thirty-four countries.

There are four drug master file entries for somatropin recombinant. Nine suppliers are listed for this compound.

Summary for Generic Name: somatropin recombinant

Tradenames:20
Patents:20
Applicants:9
NDAs:14
Drug Master File Entries: see list4
Suppliers / Packaging: see list48

Pharmacology for Ingredient: somatropin recombinant

Clinical Trials for: somatropin recombinant

Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children
Status: Active, not recruiting Condition: Hypochondroplasia

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Status: Completed Condition: Traumatic Brain Injury

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
Sandoz
OMNITROPE
somatropin recombinant
INJECTABLE;INJECTION021426-001May 30, 2006RXNo<disabled><disabled>
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-006Oct 1, 2004DISCNNo6,235,004<disabled>Y <disabled>
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-011Jan 23, 2015RXNo8,920,383<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: somatropin recombinant

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
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-001Dec 22, 19996,051,259<disabled>
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-010Jan 27, 19985,633,352<disabled>
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-004Aug 24, 19955,633,352<disabled>
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International Patent Family for Ingredient: somatropin recombinant

Country Document Number Publication Date
JapanH03503764Aug 22, 1991
European Patent Office0603159Jun 22, 1994
European Patent Office1351732Nov 18, 2015
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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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