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What is prolia for?

See the DrugPatentWatch profile for prolia

What Prolia Treats

Prolia (denosumab) is an injectable monoclonal antibody that treats osteoporosis in postmenopausal women at high risk for fracture, increases bone mass in men with osteoporosis, and prevents bone fractures in patients undergoing certain cancer treatments. It works by blocking RANKL, a protein that activates osteoclasts, reducing bone breakdown and increasing bone density.[1]

How Prolia Differs from Other Osteoporosis Drugs

Unlike bisphosphonates like Fosamax, which stay in bone long-term, Prolia is given every six months via subcutaneous injection and clears from the body faster. It shows greater bone density gains at the hip and spine in trials but requires ongoing use to avoid rapid bone loss upon stopping.[1][2]

Common Uses in Cancer Patients

Prolia prevents skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors when used with calcium and vitamin D. It's not for hypercalcemia of malignancy, where Xgeva (higher-dose denosumab) is preferred.[1]

Who Should Avoid Prolia

Pregnant women, people with low blood calcium, or those unable to take calcium/vitamin D supplements should not use it. It's contraindicated in hypersensitivity to denosumab.[1]

How Often Is Prolia Given and What Does It Cost

Administered as a 60 mg subcutaneous injection every six months by a healthcare provider. Without insurance, a single dose costs around $1,500-$2,000; patient assistance programs from Amgen can reduce this.[1][3]

Key Side Effects Patients Report

Jaw osteonecrosis (rare, ~0.1%), atypical femur fractures, and severe hypocalcemia occur. Back pain, muscle pain, and infections are more common. Stopping suddenly risks multiple vertebral fractures.[1][2]

When Does Prolia's Patent Expire

Prolia's key composition-of-matter patent (U.S. Patent No. 7,364,736) expires in 2025, with formulation patents extending protection into the early 2030s. Biosimilar challenges are ongoing.[4]

[1]: Prolia Prescribing Information (Amgen)
[2]: FDA Label for Denosumab
[3]: GoodRx Prolia Pricing
[4]: DrugPatentWatch.com - Prolia Patents



Other Questions About Prolia :

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