U.S. License Holder:
Date of License:
FORTEO (teriparatide) is recombinant human parathyroid hormone analog (1-34), [rhPTH(1-34)] indicated for:
Treatment of postmenopausal women with osteoporosis at high risk for fracture;
Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture;
Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Bonsity: Pfenex (October-2019)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Movymia (STADA Arzneimittel) (January-2017) Terrosa (Gedeon Richter) (January-2017)
Biosimilars Approved In Japan
Teriparatide BS (Gedeon Richter Plc / Mochida Pharmaceutical Co., Ltd.) (September-2019)
Biosimilars Approved In South Korea
Teribone (Dong-A St. Co., Ltd.) (November-2015) Terrosa (Daewon Pharmaceutical) (November-2019)
U.S. Patent LitigationsPACER
U.S. Patent Nos.
6,770,623 (Stabilized Teriparatide Solutions) 6,977,077 (Method of Increasing Bone Toughness and Stiffness and Reducing Fractures) 7,144,861 (Stabilized Teriparatide Solutions) 7,163,684 (Method of Increasing Bone Toughness and Stiffness and Reducing Fractures) 7,351,414 (Method of Reducing the Risk of Bone Fracture) 7,517,334 (Medication Dispensing Apparatus with Spring-Driven Locking Feature Enabled By Administration of Final Dose) 7,550,434 (Stabilized Teriparatide Solutions)
Eli Lilly and Co.
Teva Pharmaceutical Industries Ltd; Teva Pharmaceuticals USA, Inc.