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Omnitrope
Omnitrope, marketed by Sandoz, is a growth hormone indicated for treating growth retardation, currently holding a position in a competitive market. The drug's key strength lies in its established market presence, supported by a key composition patent that remains in effect until 2028. The primary risk to Omnitrope is the eventual patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | Omnitrope |
|---|---|
| Also known as | Somatropin |
| Sponsor | Sandoz |
| Target | Growth hormone receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Growth retardation
- Pituitary dwarfism
- Prader-Willi syndrome
- Severe growth hormone deficiency in adulthood
- Turner syndrome
Common side effects
- Elevated HbA1c
- Hypothyroidism
- Eosinophilia
- Hematoma
- Headache
- Hypertriglyceridemia
- Leg Pain
- Peripheral Swelling
- Arthralgia
- Injection Site Reactions/Rashes
- Lipoatrophy
- Upper Respiratory Tract Infections
Serious adverse events
- Benign Intracranial Hypertension
- Central Precocious Puberty
- Edema
- Hyperglycemia
- Scoliosis Aggravation
Key clinical trials
- Peri-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly
- ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly (PHASE2)
- Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency (PHASE3)
- Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) (PHASE2)
- Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT) (PHASE4)
- Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR) (PHASE1, PHASE2)
- Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance (PHASE2)
- A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Omnitrope CI brief — competitive landscape report
- Omnitrope updates RSS · CI watch RSS
- Sandoz portfolio CI