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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 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

Tradenames:19
Patents:18
Applicants:9
NDAs:14
Drug Master File Entries: see list4
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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-009Jan 27, 1998RXNo6,152,897<disabled>Y<disabled>
Sandoz
OMNITROPE
somatropin recombinant
INJECTABLE;INJECTION021426-001May 30, 2006RXNo<disabled><disabled>
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-009Mar 1, 2010RXNo5,849,700<disabled><disabled>
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-003Jan 27, 1998RXNo6,152,897<disabled>Y<disabled>
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-002Aug 23, 1996RXNo5,898,030<disabled>Y<disabled>
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International Patent Family for Ingredient: somatropin recombinant

Country Document Number Publication Date
Ukraine66758Jun 15, 2004
Norway20001559Mar 24, 2000
European Patent Office1003581May 31, 2000
Australia706180Jun 10, 1999
Poland323832Apr 27, 1998
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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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