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Ibandronate

Generic Name
Ibandronate
Brand Names
Bondronat, Boniva, Bonviva, Iasibon, Ibandronic acid Accord, Ibandronic Acid Sandoz, Ibandronic Acid Teva
Drug Type
Small Molecule
Chemical Formula
C9H23NO7P2
CAS Number
114084-78-5
Unique Ingredient Identifier
UMD7G2653W

Overview

Ibandronate, or BM 21.0955, is a third generation, nitrogen containing bisphosphonate similar to zoledronic acid, minodronic acid, and risedronic acid. It is used to prevent and treat postmenopausal osteoporosis. Ibandronate was first described in the literature in 1993 as a treatment for bone loss in dogs. Ibandronate was granted FDA approval on 16 May 2003.

Indication

For the treatment and prevention of osteoporosis in postmenopausal women.

Associated Conditions

  • Bone Metastases
  • Hypercalcemia of Malignancy
  • Osteoporosis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2023/09/01
Not Applicable
Not yet recruiting
2022/03/04
Not Applicable
Completed
Yeouido St. Mary's Hospital
2020/03/25
Phase 2
Completed
2017/06/14
Phase 2
Recruiting
2016/10/31
Phase 4
Completed
2016/04/15
Phase 3
Terminated
2016/03/23
Phase 3
Completed
2015/11/30
Phase 2
Completed
2015/11/13
Phase 4
Completed
2015/11/06
Phase 4
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bionpharma Inc.
69452-378
ORAL
150 mg in 1 1
5/23/2023
Aurobindo Pharma Limited
65862-237
ORAL
150 mg in 1 1
1/31/2024
Golden State Medical Supply, Inc.
60429-643
ORAL
150 mg in 1 1
9/25/2023
AuroMedics Pharma LLC
55150-191
INTRAVENOUS
3 mg in 3 mL
5/5/2022
Macleods Pharmaceuticals Limited
33342-150
ORAL
150 mg in 1 1
7/2/2022
Accord Healthcare Inc.
16729-274
INTRAVENOUS
3 mg in 3 mL
1/9/2024
Apotex Corp
60505-2795
ORAL
150 mg in 1 1
9/14/2023
Dr. Reddy's Laboratories Limited
55111-575
ORAL
150 mg in 1 1
4/30/2023
Alvogen Inc.
47781-103
ORAL
150 mg in 1 1
1/1/2017
Apotex Corp.
60505-6097
INTRAVENOUS
3 mg in 3 mL
12/14/2023

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Bondronat Tablet 50mg
SIN13425P
TABLET, FILM COATED
50mg
3/10/2008
BONDRONAT FOR INFUSION 1 mg/ml
SIN11206P
INJECTION
1mg/ml
10/29/1999
Bonviva Pre-Filled Syringe 3mg/3ml
SIN13328P
INJECTION, SOLUTION
3mg/3ml
8/2/2007
Bonviva Tablet 150 mg
SIN13206P
TABLET, FILM COATED
168.75 mg
6/19/2006

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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