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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FDA approval date

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Commercial

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Trade Name

FDA

EMA

Ferric complex in sucrose, Ferrlecit, Infed, Velphoro, Venofer (discontinued: Dexferrum, Iron dextran, Proferdex, Venofer)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ferric oxyhydroxide

Tradename	Company	Number	Date	Products
INFED	Allergan	N-017441 RX	1982-01-01	1 products, RLD, RS
VENOFER	American Regent	N-021135 RX	2000-11-06	3 products, RLD, RS
FERRLECIT	Sanofi	N-020955 RX	1999-02-18	1 products, RLD, RS
VELPHORO	Vifor	N-205109 RX	2013-11-27	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
ferrlecit	New Drug Application	2022-03-29
infed	New Drug Application	2024-10-14
iron dextran	New Drug Application	2020-02-22
velphoro	New Drug Application	2024-09-05
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

2287 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	—	—	31	59	115	132	395	715
Anemia	D000740	HP_0001903	D64.9	32	71	141	137	281	644
Iron-deficiency anemia	D018798	HP_0001891	D50	26	55	114	122	329	631
Iron overload	D019190	—	—	11	47	17	21	67	155
Deficiency diseases	D003677	EFO_1001067	E63	12	12	42	20	49	130
Kidney diseases	D007674	EFO_0003086	N08	8	12	36	26	26	106
Thalassemia	D013789	EFO_1001996	D56	11	33	12	15	42	103
Chronic renal insufficiency	D051436	—	N18	8	9	33	26	21	95
Beta-thalassemia	D017086	Orphanet_848	D56.1	8	25	10	11	24	70
Heart failure	D006333	HP_0001635	I50	2	5	14	28	16	62

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	6	10	4	—	9	25
Diabetes mellitus	D003920	HP_0000819	E08-E13	2	7	5	—	14	25
Growth disorders	D006130	—	—	—	—	1	—	16	17
Parkinson disease	D010300	EFO_0002508	G20	1	5	1	—	9	14
Fatty liver	D005234	EFO_0003934	—	1	3	2	—	9	13
Stroke	D020521	EFO_0000712	I63.9	3	2	1	—	6	12
Myeloid leukemia	D007951	—	C92	3	6	2	—	2	11
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	1	3	2	—	7	11
Hematologic diseases	D006402	EFO_0005803	D75.9	1	3	1	—	6	11
Ischemia	D007511	EFO_0000556	—	2	1	1	—	6	10

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	4	6	—	—	5	14
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	1	—	—	9	10
Cognitive dysfunction	D060825	HP_0001268	G31.84	2	3	—	—	6	10
Hypersensitivity	D006967	HP_0012393	T78.40	1	1	—	—	8	9
Cardiac surgical procedures	D006348	—	—	—	1	—	—	7	8
Lung neoplasms	D008175	HP_0100526	C34.90	1	1	—	—	5	7
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	1	2	—	—	4	7
Neurodegenerative diseases	D019636	EFO_0005772	G31.9	2	1	—	—	4	7
Replacement arthroplasty knee	D019645	—	—	—	1	—	—	6	7
Congenital heart defects	D006330	HP_0001627	Q24.9	—	2	—	—	5	7

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hookworm infections	D006725	EFO_0007314	B76	6	—	—	—	2	8
Brain neoplasms	D001932	EFO_0003833	C71	5	—	—	—	2	7
Ancylostomiasis	D000724	EFO_0007145	B76.0	6	—	—	—	1	7
Liver failure	D017093	HP_0001399	K72.9	1	—	—	—	4	5
Folic acid deficiency	D005494	EFO_0001070	E53.8	1	—	—	—	4	5
Glioblastoma	D005909	EFO_0000515	—	2	—	—	—	3	5
Medication adherence	D055118	EFO_0006344	—	1	—	—	—	3	4
Therapeutic equivalency	D013810	—	—	4	—	—	—	—	4
Hiv	D006678	—	—	1	—	—	—	2	3
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	—	—	—	2	3

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Obesity	D009765	EFO_0001073	E66.9	—	—	—	—	28	28
Blood transfusion	D001803	—	—	—	—	—	—	10	10
Micronutrients	D018977	—	—	—	—	—	—	7	7
Depression	D003863	—	F33.9	—	—	—	—	7	7
Body weight	D001835	EFO_0004338	—	—	—	—	—	6	6
Vitamin b 12 deficiency	D014806	EFO_0000734	E53.8	—	—	—	—	5	5
Nutritional status	D009752	—	—	—	—	—	—	5	5
Pre-eclampsia	D011225	EFO_0000668	O14	—	—	—	—	5	5
Tuberculosis	D014376	EFO_0000774	A15-A19	—	—	—	—	5	5
Prediabetic state	D011236	EFO_1001121	R73.03	—	—	—	—	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)	—