Yes, Omnitrope Is a Synthetic Human Growth Hormone
Omnitrope is a recombinant human growth hormone (somatropin), a lab-made version of the natural hormone produced by the pituitary gland. It mimics the body's own growth hormone to treat growth hormone deficiency in children and adults, as well as conditions like Turner syndrome, Prader-Willi syndrome, and short bowel syndrome.[1]
How Is Omnitrope Different from Natural Growth Hormone?
Natural growth hormone comes directly from the pituitary gland and varies slightly between people. Omnitrope uses DNA technology to produce an identical protein sequence (191 amino acids) in bacteria or mammalian cells, ensuring purity and consistency without animal or human sources. This makes it safer from contamination risks like prions.[1][2]
What Medical Conditions Does Omnitrope Treat?
Approved by the FDA for:
- Growth failure in children due to inadequate growth hormone secretion.
- Growth failure in children born small for gestational age.
- Short stature from Turner syndrome.
- Idiopathic short stature.
- Adult growth hormone deficiency.
- HIV-associated wasting or cachexia.[1]
Dosing is subcutaneous injection, typically daily, with amounts based on body weight or surface area.
Common Side Effects and Risks
Patients report injection site reactions, headaches, joint pain, and muscle aches. Rare risks include increased intracranial pressure, scoliosis worsening in children, or glucose intolerance. Long-term use requires monitoring for cancer risk or hypothyroidism.[1][3]
Who Makes Omnitrope and What's the Pricing?
Sandoz (a Novartis division) manufactures Omnitrope as the first FDA-approved growth hormone biosimilar to Genotropin (Pfizer). It comes in prefilled pens or vials. U.S. list prices range from $1,000-$2,000 monthly for adults, varying by dose and insurance; patient assistance programs often lower costs.[4]
Patent Status and Biosimilar Competition
Omnitrope's key patents have expired, enabling biosimilars. Check DrugPatentWatch.com for exact expiry dates on formulations and devices, as challenges continue for delivery systems.[5]
[1] FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021426s034lbl.pdf
[2] Sandoz Product Info: https://www.omnitrope.com
[3] Mayo Clinic: https://www.mayoclinic.org/drugs-supplements/somatropin-subcutaneous-route-injection/description/drg-20065949
[4] GoodRx Pricing: https://www.goodrx.com/omnitrope
[5] DrugPatentWatch: https://www.drugpatentwatch.com/p/tradename/OMNITROPE