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

Stem definition	Drug id	CAS RN
calcium metabolism regulator, pharmaceutical aid	112	66376-36-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: alendronate monosodium salt trihydrate alendronate sodium trihydrate alendronate sodium hydrate alendronate alendronic acid alendronate sodium aminohydroxybutane bisphosphonate MK-217	A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis. Molecular weight: 249.10 Formula: C4H13NO7P2 CLOGP: -3.79 LIPINSKI: 1 HAC: 8 HDO: 6 TPSA: 161.31 ALOGS: -1.17 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

alendronate monosodium salt trihydrate
alendronate sodium trihydrate
alendronate sodium hydrate
alendronate
alendronic acid
alendronate sodium
aminohydroxybutane bisphosphonate
MK-217

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

Molecular weight: 249.10
Formula: C4H13NO7P2
CLOGP: -3.79
LIPINSKI: 1
HAC: 8
HDO: 6
TPSA: 161.31
ALOGS: -1.17
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
10	mg	O
10	mg	O
10	mg	O
10	mg	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	45 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	3.10 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.68 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
CL (Clearance)	2.60 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)	0.33 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.22 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Sept. 29, 1995	FDA	MERCK AND CO INC

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
Femur fracture	6779.38	10.70	3911	412316	37845	63034950
Low turnover osteopathy	3111.52	10.70	1133	415094	3052	63069743
Osteonecrosis	2689.81	10.70	1791	414436	22739	63050056
Pemphigus	2497.72	10.70	4385	411842	179341	62893454
Osteonecrosis of jaw	2366.65	10.70	1911	414316	33212	63039583
Systemic lupus erythematosus	2212.84	10.70	4482	411745	204436	62868359
Intramedullary rod insertion	2191.08	10.70	734	415493	1389	63071406
Glossodynia	2111.33	10.70	4017	412210	174859	62897936
Hand deformity	1586.77	10.70	3336	412891	156121	62916674
Stress fracture	1502.34	10.70	824	415403	7139	63065656

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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	399.20	11.31	237	40750	14653	34901291
Osteonecrosis of jaw	339.91	11.31	229	40758	17660	34898284
Femur fracture	270.51	11.31	149	40838	7975	34907969
Atypical femur fracture	188.06	11.31	49	40938	285	34915659
Low turnover osteopathy	175.32	11.31	37	40950	65	34915879
Osteomyelitis	130.07	11.31	125	40862	16011	34899933
Osteoporosis	125.21	11.31	110	40877	12558	34903386
Toxicity to various agents	124.57	11.31	40	40947	200322	34715622
Impaired healing	124.00	11.31	119	40868	15215	34900729
Intramedullary rod insertion	111.92	11.31	21	40966	11	34915933

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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
Femur fracture	3837.20	10.43	2222	320524	36430	79385212
Osteonecrosis of jaw	2895.30	10.43	1935	320811	41291	79380351
Osteonecrosis	2503.68	10.43	1563	321183	29532	79392110
Pemphigus	1744.19	10.43	2082	320664	97500	79324142
Atypical femur fracture	1616.42	10.43	654	322092	4535	79417107
Systemic lupus erythematosus	1580.86	10.43	2189	320557	118960	79302682
Glossodynia	1536.18	10.43	1990	320756	101347	79320295
Hand deformity	1493.17	10.43	1968	320778	101951	79319691
Arthropathy	1381.39	10.43	2529	320217	174582	79247060
Low turnover osteopathy	1341.50	10.43	443	322303	1543	79420099

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M05BA04	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates
ATC	M05BB03	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB05	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB06	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
CHEBI has role	CHEBI:50643	dimethylallyltranstransferase inhibitors
CHEBI has role	CHEBI:50646	antiosteoporotic
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
Osteitis deformans	indication	2089002	DOID:5408
Postmenopausal osteoporosis	indication	102447009
Hypogonadal Osteoporosis in Males	indication
Prevention of Glucocorticoid-Induced Osteoporosis	indication
Glucocorticoid Induced Osteoporosis	indication
Complex regional pain syndrome	off-label use	128200000	DOID:3223
Gastritis	contraindication	4556007	DOID:4029
Hypocalcemia	contraindication	5291005
Esophagitis	contraindication	16761005	DOID:11963
Hyperphosphatemia	contraindication	20165001	DOID:0050459

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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	1.27	acidic
pKa2	5.34	acidic
pKa3	6.32	acidic
pKa4	10.39	acidic
pKa5	12.82	acidic
pKa6	10.98	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 70MG BASE/75ML	ALENDRONATE SODIUM	NOVITIUM PHARMA	A214512	May 11, 2023	RX	SOLUTION	ORAL	Nov. 20, 2023	COMPETITIVE GENERIC THERAPY

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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	7.35	CHEMBL	CHEMBL
Protein farnesyltransferase subunit beta	Enzyme	P49356	FNTB_HUMAN		IC50	7.30	WOMBAT-PK
Farnesyl pyrophosphate synthase	Enzyme		Q0GKD7_LEIDO		Ki	7.02	CHEMBL
Farnesyl pyrophosphate synthase	Enzyme		FPPS_RAT		IC50	5.77	CHEMBL
Isopentenyl-diphosphate Delta-isomerase 1	Enzyme		IDI1_RAT		IC50	5.77	CHEMBL
Farnesyl pyrophosphate synthase	Enzyme		FPPS_MOUSE		IC50	4.82	CHEMBL
Farnesyl pyrophosphate synthase, EC 2.5.1.1, EC 2.5.1.10	Unclassified		Q4QBL1_LEIMA		Ki	7.04	CHEMBL

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External reference:

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ID	Source
212	PDB_CHEM_ID
005056	NDDF
005057	NDDF
121268-17-5	SECONDARY_CAS_RN
1217581008	SNOMEDCT_US
131536	MMSL
203152	RXNORM
2088	PUBCHEM_CID
3141	IUPHAR_LIGAND_ID
391729003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Alendronate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-696	TABLET	35 mg	ORAL	ANDA	27 sections
Alendronate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-697	TABLET	70 mg	ORAL	ANDA	27 sections
Alendronate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-718	TABLET	35 mg	ORAL	ANDA	29 sections
Alendronate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-718	TABLET	35 mg	ORAL	ANDA	29 sections
Alendronate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-719	TABLET	70 mg	ORAL	ANDA	29 sections
Alendronate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-719	TABLET	70 mg	ORAL	ANDA	29 sections
Alendronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0282	SOLUTION	70 mg	ORAL	ANDA	28 sections
Alendronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1676	TABLET	5 mg	ORAL	ANDA	29 sections
Alendronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1676	TABLET	5 mg	ORAL	ANDA	29 sections
Alendronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1678	TABLET	10 mg	ORAL	ANDA	29 sections

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