NUTROPIN
LOE ApproachingBLAInjectionInjectable
Approved
Mar 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
2/8 — Basic
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUTROPIN is a recombinant human growth hormone (somatropin) approved in 1994 for treating growth disorders and related conditions. Administered via injection, it replaces or supplements endogenous growth hormone in patients with deficiency or dysfunction. The cytokine modality directly addresses the underlying physiological deficit in GH-responsive populations.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely scaling defensively and exploring life-cycle management strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
Started Mar 2015
82 enrolled
Growth Hormone Deficiency
Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers
Started Aug 2013
0Growth DisorderHealthy
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
Started Nov 2010
18 enrolled
Growth Hormone Deficiency
A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders
Started Jun 2006
3,690 enrolled
Growth Hormone Disorders
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
Started Jun 2006
546 enrolled
Growth Hormone Disorders
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.