U.S. License Holder:
Amgen
Date of License:
June-01-2010
Last Update:
May-23-2023
FDA-Approved Indications
PROLIA (denosumab) is a RANK ligand (RANKL) inhibitor indicated for:
Treatment of postmenopausal women with osteoporosis at high risk for fracture;
Treatment to increase bone mass in men with osteoporosis at high risk for fracture;
Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture;
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer;
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
XGEVA (denosumab) is a RANK ligand (RANKL) inhibitor indicated for:
Prevention of skeletal-related events in patients with multiple myeloma and in pateients with bone metastases from solid tumors;
Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity;
Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Accepted by FDA
GP2411: Sandoz (February-2023)
U.S. Patent Litigations