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Details for Generic Name: somatropin recombinant

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Somatropin recombinant is the generic ingredient in nineteen 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 sixty-one patent family members in thirty-four countries.

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

Summary for Generic Name: somatropin recombinant

Tradenames:19
Patents:18
Applicants:9
NDAs:14
Drug Master File Entries: see list2
Suppliers: see list9
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 ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-002Aug 23, 1996RXNo5,898,030<disabled>Y<disabled>
Genentech
NUTROPIN AQ
somatropin recombinant
INJECTABLE;INJECTION020522-001Dec 29, 1995RXYes5,763,394<disabled>Y<disabled>
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-005Oct 1, 2004DISCNNo6,235,004<disabled>Y<disabled>
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION019721-002May 8, 1995DISCNNo<disabled><disabled>
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-009Mar 1, 2010RXNo6,899,699<disabled>Y<disabled>
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International Patent Family for Ingredient: somatropin recombinant

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2006045526May 04, 2006
Norway942300Jun 17, 1994
European Patent Office0679103Nov 02, 1995
Portugal644771Dec 31, 2002
China1130223Dec 10, 2003
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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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