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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 eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and seventy-seven 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

Drug Master File Entries: see list4
Suppliers / Packaging: see list48
Formulation / Manufacturing:see details

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: Recruiting Condition: Traumatic Brain Injury

Courtesy of
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
somatropin recombinant
INJECTABLE;INJECTION021148-004Oct 1, 2004DISCNNo5,849,704<disabled>Y <disabled>
Pharmacia And Upjohn
somatropin recombinant
INJECTABLE;INJECTION020280-007Oct 23, 1996RXYes<disabled><disabled>
Novo Nordisk Inc
somatropin recombinant
INJECTABLE;INJECTION021148-005Oct 1, 2004DISCNNo5,849,700<disabled> <disabled>
Emd Serono
somatropin recombinant
INJECTABLE;INJECTION019764-002Oct 8, 1996RXNo5,898,030<disabled>Y <disabled>
Emd Serono
somatropin recombinant
INJECTABLE;INJECTION019764-005Jan 16, 2007DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: somatropin recombinant

Country Document Number Publication Date
Germany69329295Mar 15, 2001
Norway975708Dec 05, 1997
World Intellectual Property Organization (WIPO)9640072Dec 19, 1996
Australia4630893Jan 04, 1994
European Patent Office1250167Jul 20, 2005
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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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