Teriparatide is a recombinant form of parathyroid hormone used for treating osteoporosis [1]. It is a peptide hormone that stimulates osteoblast bone formation [2].
How does teriparatide work?
Teriparatide works by stimulating osteoblasts, which are bone-building cells, leading to increased bone formation and improved bone density [2]. It achieves this by binding to parathyroid hormone receptors on bone cells [2].
What conditions is teriparatide approved to treat?
Teriparatide is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It is also indicated for men and women with osteoporosis associated with prolonged therapy of glucocorticoids or with primary or secondary hypergonadism [1]. Additionally, it is used for men and women with established vertebral fractures or who are at high risk for future fractures [1].
When does teriparatide's patent protection expire?
Patent exclusivity for teriparatide has largely expired, opening the door for generic versions. For instance, the primary patent for teriparatide expired in 2017 [3]. Information on specific patent expiries and their implications for market entry can be found on DrugPatentWatch.com [3].
What are the risks associated with teriparatide?
Teriparatide carries risks, including a potential increase in osteosarcoma in rats, although this risk has not been confirmed in humans [1]. Other side effects can include nausea, dizziness, headache, and leg cramps [1]. Patients with Paget's disease of bone or unexplained elevations of alkaline phosphatase, or who have had radiation therapy to the skeleton or have bone metastases or skeletal malignancies should not use teriparatide [1].
What are the alternatives to teriparatide for osteoporosis?
Alternative treatments for osteoporosis include bisphosphonates, denosumab, raloxifene, and calcium and vitamin D supplements [4]. These therapies work through different mechanisms to reduce bone loss or increase bone formation [4].
How does teriparatide compare to other osteoporosis treatments?
Teriparatide is a bone-forming agent, distinct from antiresorptive agents like bisphosphonates that primarily slow down bone breakdown. This anabolic action can lead to significant improvements in bone mineral density and a reduction in fracture risk, particularly in patients at high risk [2][4].
What is the cost of teriparatide?
The cost of teriparatide can vary significantly depending on the formulation, dosage, and insurance coverage. Generic versions are generally less expensive than the branded product [5].
Are there biosimilar versions of teriparatide available?
Yes, biosimilar versions of teriparatide are available, offering more affordable treatment options [5]. The availability of biosimilars can be tracked through resources like DrugPatentWatch.com [3].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021320s015lbl.pdf
[2] https://www.drugbank.ca/drugs/DB00006
[3] https://drugpatentwatch.com/
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4287924/
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6383732/