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ibandronic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
calcium metabolism regulator, pharmaceutical aid	1404	114084-78-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: bonviva ibandronic acid ibandronate boniva ibandronate sodium	Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS. Molecular weight: 319.23 Formula: C9H23NO7P2 CLOGP: -1.52 LIPINSKI: 0 HAC: 8 HDO: 5 TPSA: 138.53 ALOGS: -1.38 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

bonviva
ibandronic acid
ibandronate
boniva
ibandronate sodium

Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS.

Molecular weight: 319.23
Formula: C9H23NO7P2
CLOGP: -1.52
LIPINSKI: 0
HAC: 8
HDO: 5
TPSA: 138.53
ALOGS: -1.38
ROTB: 9

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
5	mg	O
6	mg	P

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	55 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	14 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.80 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.55 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.15 %	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.13 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
June 25, 1996	EMA	Atnahs Pharma Netherlands B.V.
May 16, 2003	FDA	HOFFMANN LA ROCHE

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Osteonecrosis of jaw	1514.99	12.09	647	42592	34476	63411307
Femur fracture	1348.16	12.09	628	42611	41128	63404655
Low turnover osteopathy	623.82	12.09	193	43046	3992	63441791
Osteonecrosis	621.95	12.09	313	42926	24217	63421566
Bone pain	600.61	12.09	405	42834	54236	63391547
Atypical femur fracture	448.44	12.09	160	43079	5212	63440571
Stress fracture	397.41	12.09	163	43076	7800	63437983
Myalgia	273.11	12.09	412	42827	146117	63299666
Intramedullary rod insertion	266.89	12.09	86	43153	2037	63443746
Drug ineffective	248.21	12.09	210	43029	1044555	62401228

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Osteonecrosis of jaw	151.50	21.96	53	2206	17836	34936836
Osteonecrosis	99.28	21.96	37	2222	14853	34939819
Appetite disorder	40.03	21.96	12	2247	2459	34952213
Femur fracture	39.25	21.96	16	2243	8108	34946564
Rectal polyp	38.46	21.96	9	2250	710	34953962
Jaw fracture	30.18	21.96	8	2251	1050	34953622
Fall	25.09	21.96	46	2213	202839	34751833

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Osteonecrosis of jaw	1517.85	12.81	575	28322	42651	79672840
Femur fracture	828.12	12.81	361	28536	38291	79677200
Osteonecrosis	521.65	12.81	245	28652	30850	79684641
Atypical femur fracture	465.64	12.81	140	28757	5049	79710442
Bone pain	402.60	12.81	251	28646	55491	79660000
Low turnover osteopathy	297.71	12.81	80	28817	1906	79713585
Stress fracture	251.63	12.81	93	28804	6387	79709104
Exposed bone in jaw	215.85	12.81	72	28825	3648	79711843
Osteomyelitis	183.36	12.81	126	28771	32739	79682752
Dental caries	155.65	12.81	79	28818	11741	79703750

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M05BA06	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates
ATC	M05BB09	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
FDA CS	M0006519	Diphosphonates
FDA EPC	N0000175579	Bisphosphonate
MeSH PA	D050071	Bone Density Conservation Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Hypercalcemia	indication	66931009	DOID:12678
Postmenopausal osteoporosis	indication	102447009
Gastritis	contraindication	4556007	DOID:4029
Hypocalcemia	contraindication	5291005
Bone pain	contraindication	12584003
Heartburn	contraindication	16331000
Esophagitis	contraindication	16761005	DOID:11963
Swallowing painful	contraindication	30233002
Ulcer of esophagus	contraindication	30811009
Vitamin D deficiency	contraindication	34713006

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.98	acidic
pKa2	4.97	acidic
pKa3	9.03	acidic
pKa4	13.3	acidic
pKa5	7.94	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BONIVA	HOFFMANN LA ROCHE	N021455	March 24, 2005	DISCN	TABLET	ORAL	7192938	May 6, 2023	TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID
EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BONIVA	HOFFMANN LA ROCHE	N021455	March 24, 2005	DISCN	TABLET	ORAL	7410957	May 6, 2023	TREATMENT AND PREVENTION OF OSTEOPOROSIS
EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BONIVA	HOFFMANN LA ROCHE	N021455	March 24, 2005	DISCN	TABLET	ORAL	7718634	May 6, 2023	TREATMENT AND PREVENTION OF OSTEOPOROSIS

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Farnesyl pyrophosphate synthase	Enzyme	P14324	FPPS_HUMAN	INHIBITOR	Ki	8.44	CHEMBL	CHEMBL
Geranylgeranyl pyrophosphate synthase	Enzyme	O95749	GGPPS_HUMAN		IC50	4.10	CHEMBL
Squalene synthase	Enzyme		FDFT_RAT		IC50	6.19	CHEMBL
Farnesyl pyrophosphate synthase	Enzyme		FPPS_RAT	INHIBITOR	IC50	5.13	IUPHAR

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External reference:

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ID	Source
BFQ	PDB_CHEM_ID
007178	NDDF
007179	NDDF
115264	RXNORM
138926-19-9	SECONDARY_CAS_RN
188271	MMSL
3059	IUPHAR_LIGAND_ID
395271007	SNOMEDCT_US
4021407	VANDF
404839003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Boniva	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0186	TABLET, FILM COATED	150 mg	ORAL	NDA	27 sections
Boniva	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5322	TABLET, FILM COATED	150 mg	ORAL	NDA	28 sections
ibandronate sodium	HUMAN PRESCRIPTION DRUG LABEL	1	25021-827	INJECTION, SOLUTION	3 mg	INTRAVENOUS	ANDA	30 sections
IBANDRONATE SODIUM	Human Prescription Drug Label	1	33342-150	TABLET, FILM COATED	150 mg	ORAL	ANDA	27 sections
IBANDRONATE SODIUM	Human Prescription Drug Label	1	33342-150	TABLET, FILM COATED	150 mg	ORAL	ANDA	27 sections
IBANDRONATE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	47781-103	TABLET	150 mg	ORAL	ANDA	27 sections
IBANDRONATE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	47781-103	TABLET	150 mg	ORAL	ANDA	27 sections
IBANDRONATE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	51224-008	INJECTION, SOLUTION	3 mg	INTRAVENOUS	ANDA	31 sections
IBANDRONATE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	51224-008	INJECTION, SOLUTION	3 mg	INTRAVENOUS	ANDA	31 sections
Ibandronate sodium	HUMAN PRESCRIPTION DRUG LABEL	1	55111-575	TABLET	150 mg	ORAL	ANDA	26 sections

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