What is Omnitrope?
Omnitrope is a recombinant human growth hormone (somatropin) used to treat growth hormone deficiency in children and adults, as well as conditions like Turner syndrome, Prader-Willi syndrome, and idiopathic short stature. Approved by the FDA in 2006, it is the first somatropin approved as a biosimilar to Genotropin (Pfizer's brand), offering the same active ingredient produced via DNA technology.[1]
How does Omnitrope work?
It mimics the natural growth hormone produced by the pituitary gland, stimulating growth in bones and muscles, regulating metabolism, and supporting cell reproduction. Administered via subcutaneous injection, typical doses range from 0.015 to 0.03 mg/kg daily, adjusted by age, weight, and condition.[1][2]
Who makes Omnitrope and when was it approved?
Sandoz, a Novartis division, manufactures Omnitrope. The FDA approved it on May 30, 2006, following European approval in 2006 as the world's first somatropin biosimilar. It comes in prefilled pens (5 mg/1.5 mL or 10 mg/1.5 mL) or vials for reconstitution.[1]
What are common uses and who is it for?
Primarily for:
- Pediatric growth hormone deficiency.
- Adults with acquired growth hormone deficiency.
- Children with Turner syndrome, Prader-Willi, chronic kidney disease, or Noonan syndrome (off-label in some cases).
Not for idiopathic short stature in all regions; requires diagnosis via stimulation tests.[2]
What side effects do patients report?
Common issues include injection-site reactions, headache, muscle pain, joint stiffness, and fluid retention. Rare risks: increased intracranial pressure, scoliosis worsening, or glucose intolerance. Long-term use needs monitoring for malignancy risk or hypothyroidism.[2]
How does it compare to Genotropin or Norditropin?
Omnitrope matches Genotropin's efficacy and safety in clinical trials, with bioequivalence shown in pharmacokinetics. It's often cheaper as a biosimilar. Norditropin (Novo Nordisk) has similar indications but different delivery (FlexPro pens). All are somatropin but vary in excipients and devices.[1]
When do Omnitrope patents expire?
Key U.S. patents cover formulation and delivery; the primary method-of-use patent (U.S. Patent 7,615,532) expired in 2021. Check DrugPatentWatch.com for latest litigation and ANDA filings on remaining device patents.[3]
Cost and access for patients
U.S. list price is around $1,000-$1,500 monthly (varies by dose), but copay assistance from Sandoz caps out-of-pocket at $0-$30 for eligible patients. Insurance often covers with prior authorization; patient programs like Omnitrope Complete Savings offer free meds for uninsured kids.[2]
[1]: FDA Label - Omnitrope (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021426s034lbl.pdf)
[2]: Sandoz Omnitrope prescribing information (https://www.omnitrope.com/)
[3]: DrugPatentWatch.com - Omnitrope patents (https://www.drugpatentwatch.com/p/tradename/OMNITROPE)