Regulatory PathRegulatory requirements compared

Active substance

Ibandronic acid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BONVIVA 150 MG F.C. TABLETS150 mgFilm-coated tablet · Oral use1 BlisterSAR 81.30NCE · PrescriptionAtnahs Pharma UK LimitedValid
BONDRONAT 2MG-2ML AMPOULE1 mg/mlInjection · Intravenous use1 AmpouleSAR 476.95NCE · PrescriptionROCHE DIAGNOSTICSWithdrawn by MAH · Not Marketed
BONVIVA 3MG-3ML PREFILLED SYRINGES1 mg/mlInjection · Intravenous use1 Pre-filled syringeSAR 492.30NCE · PrescriptionROCHE & CO LTDWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HYPERPARATHYRODISM; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; OSTEOPOROSIS; SPINAL MUSCULAR ATROPHY - MAINTENANCE OF BONE HEALTH

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

ProductStrengthForm · routeApplicantStatusFirst approved
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralAPOTEX INCPrescription19 Mar 2012
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralORBION PHARMSPrescription19 Mar 2012
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralDR REDDYS LABS LTDPrescription30 Apr 2012
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousEUGIA PHARMAPrescription19 Aug 2015
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousAPOTEXPrescription16 Oct 2015
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousACCORD HLTHCAREPrescription5 Feb 2016
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralAUROBINDO PHARMAPrescription11 Mar 2016
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralMACLEODS PHARMSPrescription31 Oct 2017
BONIVAEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralHOFFMANN LA ROCHEDiscontinued16 May 2003
BONIVAEQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · intravenousROCHEDiscontinued6 Jan 2006
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralPHARMOBEDIENTDiscontinued19 Mar 2012
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralWATSON LABS TEVADiscontinued20 Mar 2012
IBANDRONATE SODIUMEQ 150MG BASEtablet · oralSUN PHARM INDUSTRIESDiscontinued15 Aug 2012
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousSUN PHARMDiscontinued14 Feb 2014
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousCHEMI SPADiscontinued2 Sep 2014
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousPHARMOBEDIENTDiscontinued2 Sep 2014
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousAVET LIFESCIENCESDiscontinued2 Sep 2014
IBANDRONATE SODIUMEQ 3MG BASE/3MLinjectable · intravenousNANG KUANG PHARM CODiscontinued16 Jun 2021

EMA European Union — centrally authorised medicines

Bondronat Atnahs Pharma Netherlands B.V. · Authorised · authorised 25 Jun 1996 · ATC M05BA06

Therapeutic indication (EMA)

Bondronat is indicated for: prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases; treatment of tumour-induced hypercalcaemia with or without metastases.

Bonviva Atnahs Pharma Netherlands B.V. · Authorised · authorised 23 Feb 2004 · ATC M05BA06

Therapeutic indication (EMA)

Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Ibandronic Acid Teva Teva Pharma B.V. · Authorised · authorised 17 Sep 2010 · ATC M05BA06

Therapeutic indication (EMA)

Ibandronic acid 50mg Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Ibandronic acid 150mg Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Iasibon Pharmathen S.A. · Authorised · authorised 21 Jan 2011 · ATC M05BA06

Therapeutic indication (EMA)

Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Ibandronic acid Accord Accord Healthcare S.L.U. · Authorised · authorised 18 Nov 2012 · ATC M05BA06

Therapeutic indication (EMA)

Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Ibandronic Acid Hexal Hexal AG · Application withdrawn · ATC M05BA06

Therapeutic indication (EMA)

Ibandronic Acid Hexal is indicated for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases.

Destara Roche Registration Ltd. · Withdrawn · authorised 25 Jun 1996 · ATC M05BA06

Therapeutic indication (EMA)

Treatment of tumour-induced hypercalcaemia with or without metastases.

Bondenza (previously Ibandronic Acid Roche) Roche Registration Ltd. · Withdrawn · authorised 23 Feb 2004 · ATC M05BA06

Therapeutic indication (EMA)

Treatment of osteoporosis in post-menopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established.

Ibandronic Acid Sandoz Sandoz GmbH · Lapsed · authorised 26 Jul 2011 · ATC M05BA06

Therapeutic indication (EMA)

Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACIBANDRONATE 3 MG/3 ML SYRINGE$52.64778per ML23 Sep 2026
US NADACIBANDRONATE SODIUM 150 MG TAB$2.67507per EA23 Sep 2026
NHS Drug TariffIbandronic acid 150mg tablets£16.601 tablet1 Oct 2026
NHS Drug TariffIbandronic acid 3mg/3ml solution for injection pre-filled syringes£65.401 pre-filled disposable injection1 Oct 2026
NHS Drug TariffIbandronic acid 50mg tablets£39.8028 tablet1 Oct 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 ibandronic acid →

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.