Iron dextran - PharmaKB

Iron dextran

Ferric Oxyhydroxide, Ferrlecit, Infed, Velphoro, Venofer (iron dextran) is an unknown pharmaceutical. Iron dextran was first approved as Infed on 1982-01-01.

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EMA approval date

Patent expiration date

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Commercial

Therapeutic Areas

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Trade Name

FDA

EMA

Infed (discontinued: Dexferrum, Iron dextran, Proferdex)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Iron dextran

Tradename	Company	Number	Date	Products
INFED	Allergan	N-017441 RX	1982-01-01	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
infed	New Drug Application	2024-10-14
iron dextran	New Drug Application	2025-01-08
venofer	New Drug Application	2022-07-25
venofer (iron sucrose)	New Drug Application	2024-04-19

Indications

FDA

EMA

No data

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Ferric Oxyhydroxide, Velphoro, Vifor Fresenius
10624855	2034-11-26	DP
11234938	2034-11-26	DP
11446252	2034-11-26	DP
9561251	2030-01-23	DP	U-1468
10682376	2028-11-13	DP
10695367	2028-11-13	DP
10925896	2028-11-13	DP
10925897	2028-11-13	DP
10933090	2028-11-13	DP
11013761	2028-11-13	DP
11013762	2028-11-13	DP

ATC Codes

No data

HCPCS

Code	Description
J1750	Injection, iron dextran, 50 mg

Clinical

Clinical Trials

2403 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Iron deficiencies	D000090463	—	E61.1	28	52	108	127	410	711
Anemia	D000740	EFO_0004272	D64.9	34	71	141	135	302	666
Iron-deficiency anemia	D018798	—	D50	28	50	109	115	355	643
Iron overload	D019190	—	—	10	46	17	21	67	153
Deficiency diseases	D003677	EFO_1001067	E63	9	7	38	19	47	118
Chronic renal insufficiency	D051436	—	N18	8	11	38	27	21	103
Kidney diseases	D007674	EFO_0003086	N08	7	12	36	22	27	102
Thalassemia	D013789	EFO_1001996	D56	10	27	10	13	37	88
Heart failure	D006333	EFO_0003144	I50	3	4	15	30	17	66
Beta-thalassemia	D017086	Orphanet_848	D56.1	7	22	10	10	24	65

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Growth disorders	D006130	—	—	—	—	2	—	18	20
Leukemia	D007938	—	C95	2	6	3	—	8	17
Diabetes mellitus	D003920	EFO_0000400	E08-E13	1	4	2	—	11	17
Child development	D002657	—	—	—	—	2	—	13	15
Parkinson disease	D010300	EFO_0002508	G20	2	4	1	—	9	14
Cardiovascular diseases	D002318	EFO_0000319	I98	5	2	1	—	8	14
Liver diseases	D008107	EFO_0001421	K70-K77	1	2	1	—	9	13
Fatty liver	D005234	EFO_0003934	—	1	3	2	—	9	13
Blood transfusion	D001803	—	—	—	1	1	—	10	11
Nerve degeneration	D009410	—	—	—	1	2	—	8	11

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Metabolic diseases	D008659	EFO_0000589	E88.9	1	1	—	—	13	15
Brain neoplasms	D001932	EFO_0003833	C71	6	4	—	—	1	11
Cardiac surgical procedures	D006348	—	—	1	1	—	—	8	10
Myeloid leukemia acute	D015470	—	C92.0	1	5	—	—	4	9
Cognitive dysfunction	D060825	—	G31.84	1	2	—	—	6	9
Hereditary hemorrhagic telangiectasia	D013683	—	I78.0	1	2	—	—	5	8
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	1	—	—	7	8
Glioblastoma	D005909	EFO_0000515	—	3	1	—	—	4	8
Neurodegenerative diseases	D019636	EFO_0005772	G31.9	1	1	—	—	6	8
Replacement arthroplasty knee	D019645	—	—	—	1	—	—	6	7

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Obesity	D009765	EFO_0001073	E66.9	2	—	—	—	27	29
Hookworm infections	D006725	EFO_0007314	B76	6	—	—	—	2	8
Ancylostomiasis	D000724	EFO_0007145	B76.0	6	—	—	—	1	7
Vasodilation	D014664	—	—	3	—	—	—	3	6
Lung neoplasms	D008175	—	C34.90	1	—	—	—	5	6
Folic acid deficiency	D005494	EFO_0001070	E53.8	1	—	—	—	5	6
Hepatic insufficiency	D048550	—	—	2	—	—	—	3	5
Body weight	D001835	EFO_0004338	—	1	—	—	—	4	5
Vasoconstriction	D014661	—	—	3	—	—	—	2	5
Aging	D000375	GO_0007568	R41.81	2	—	—	—	3	5

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypersensitivity	D006967	EFO_0003785	T78.40	—	—	—	—	8	8
Nutrition disorders	D009748	EFO_0001069	—	—	—	—	—	7	7
Breast feeding	D001942	—	—	—	—	—	—	7	7
Nutritional status	D009752	—	—	—	—	—	—	7	7
Vitamin b 12 deficiency	D014806	EFO_0000734	E53.8	—	—	—	—	6	6
Pre-eclampsia	D011225	EFO_0000668	O14	—	—	—	—	6	6
Gestational weight gain	D000078064	—	—	—	—	—	—	5	5
Tuberculosis	D014376	EFO_0000774	A15-A19	—	—	—	—	5	5
Exercise	D015444	EFO_0000483	—	—	—	—	—	4	4
Respiratory tract infections	D012141	—	J06.9	—	—	—	—	4	4

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Iron dextran
INN	_
Description	Iron supplements, also known as iron salts and iron pills, are a number of iron formulations used to treat and prevent iron deficiency including iron deficiency anemia. For prevention they are only recommended in those with poor absorption, heavy menstrual periods, pregnancy, hemodialysis, or a diet low in iron. Prevention may also be used in low birth weight babies. They are taken by mouth, injection into a vein, or injection into a muscle. While benefits may be seen in days, up to two months may be required until iron levels return to normal.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—