Regulatory PathRegulatory requirements compared

Active substance

Teriparatide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Bonteo 20 mcg per 80 mcl250 µ/mlSolution for injection · Subcutaneous use1 Pre-filled penSAR 1155.35Biological · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
FORTEO 20 MCG per 80MCL250 µ/mlSolution for injection · Subcutaneous use1 Pre-filled penSAR 1421.95Biological · PrescriptionELI LILLY NEDERLAND B.V.Valid
Sondelbay250 µg/mlSolution for injection · Subcutaneous use1 Pre-filled penSAR 952.90Biological · PrescriptionBoston Oncology ArabiaValid
TERROSA250 µ/mlSolution for injection · Subcutaneous use1 CartridgeSAR 1003.05Biological · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
Indications — CHI Daman Drug Formulary

HYPOPARATHYROIDISM; OSTEOPOROSIS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
FORTEO0.56MG/2.24ML (0.25MG/ML)solution · subcutaneousLILLYPrescription26 Nov 2002
BONSITY0.56MG/2.24ML (0.25MG/ML)solution · subcutaneousALVOGENPrescription4 Oct 2019
TERIPARATIDE0.56MG/2.24ML (0.25MG/ML)solution · subcutaneousTEVA PHARMS USAPrescription16 Nov 2023
TERIPARATIDE0.56MG/2.24ML (0.25MG/ML)solution · subcutaneousAPOTEXPrescription16 Nov 2023
TERIPARATIDE0.56MG/2.24ML (0.25MG/ML)solution · subcutaneousALMAJECTPrescription4 Jun 2024
TERIPARATIDE0.56MG/2.24ML (0.25MG/ML)solution · subcutaneousAMPHASTAR PHARMS INCPrescription12 Dec 2025
FORTEO0.75MG/3ML (0.25MG/ML)solution · subcutaneousLILLYDiscontinued26 Nov 2002
PARATHAR200 UNITS/VIALinjectable · injectionSANOFI AVENTIS USDiscontinued

EMA European Union — centrally authorised medicines

Forsteo Eli Lilly Nederland B.V. · Authorised · authorised 10 Jun 2003 · ATC H05AA02

Therapeutic indication (EMA)

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Terrosa Gedeon Richter Plc. · Authorised · authorised 4 Jan 2017 · ATC H05AA02

Therapeutic indication (EMA)

Terrosa is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Movymia STADA Arzneimittel AG · Authorised · authorised 11 Jan 2017 · ATC H05AA02

Therapeutic indication (EMA)

Movymia is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Livogiva Theramex Ireland Limited · Authorised · authorised 27 Aug 2020 · ATC H05AA02

Therapeutic indication (EMA)

Livogiva is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Sondelbay Accord Healthcare S.L.U. · Authorised · authorised 24 Mar 2022 · ATC H05AA02

Therapeutic indication (EMA)

Sondelbay is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Teriparatide Sun Sun Pharmaceutical Industries Europe B.V. · Authorised · authorised 18 Nov 2022 · ATC H05AA02

Therapeutic indication (EMA)

Teriparatide SUN is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).

Kauliv Strides Pharma (Cyprus) Limited · Authorised · authorised 12 Jan 2023 · ATC H05AA02

Therapeutic indication (EMA)

Kauliv is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).

Zandoriah CinnaGen Co Unipessoal LDA · Authorised · authorised 27 Apr 2026 · ATC H05AA02

Therapeutic indication (EMA)

Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Sondelbay Accord Healthcare S.L.U. · Application withdrawn · ATC H05AA02

Therapeutic indication (EMA)

Treatment of osteoporosis

Teriparatide Cinnagen CinnaGen Co Unipessoal LDA · Application withdrawn · ATC H05AA02

Therapeutic indication (EMA)

Treatment of osteoporosis

Teriparatide Ascend Ascend GmbH · Application withdrawn · ATC H05AA02

Therapeutic indication (EMA)

Treatment of osteoporosis

Qutavina EuroGenerics Holdings B.V. · Withdrawn · authorised 27 Aug 2020 · ATC H05AA02

Therapeutic indication (EMA)

Qutavina is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-TERIPARATIDE INJECTION02498804250 MCG / MLSOLUTION · SUBCUTANEOUSAPOTEX INC
OSNUVO02495589250 MCG / MLSOLUTION · SUBCUTANEOUSAVIR PHARMA INC.
TEVA-TERIPARATIDE INJECTION02486423250 MCG / MLSOLUTION · SUBCUTANEOUSTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBONSITY 560 MCG/2.24 ML PEN$479.95105per ML23 Sep 2026
US NADACFORTEO 560 MCG/2.24 ML PEN INJ$1841.27488per ML23 Sep 2026
US NADACTERIPARATIDE 560 MCG/2.24 ML PEN$479.95105per ML23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for teriparatide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.