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Drug ReportsBiotin
Biotin
Berocca Pn, Infuvite, M.v.c. 9+, M.v.i, M.v.i. Lyophilized, Mvc, Vitaped (biotin) is a small molecule pharmaceutical. Biotin was first approved as M.v.i.-12 lyophilized on 1985-08-08. It is used to treat inborn errors metabolism and vitamin b deficiency in the USA. It is known to target urotensin-2 receptor.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Combinations
Infuvite (discontinued: Berocca pn, M.v.c. 9+, M.v.i., M.v.i. lyophilized, Mvc, Vitaped)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin e
Tradename
Company
Number
Date
Products
BEROCCA PNRocheN-006071 DISCN1985-10-10
1 products
Hide discontinued
Alpha-tocopherol acetate
+
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin k
Tradename
Company
Number
Date
Products
INFUVITE ADULTSandozN-021163 RX2000-05-18
2 products, RLD, RS
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Tocopherol acetate
+
Vitamin a
+
Vitamin k
Tradename
Company
Number
Date
Products
INFUVITE PEDIATRICSandozN-021265 RX2001-02-21
1 products, RLD, RS
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)SandozN-021265 RX2004-01-29
1 products, RLD, RS
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.C. 9+3APP PharmaceuticalsN-018440 DISCN1985-08-08
1 products
M.V.I.-12 ADULTHospiraN-008809 DISCN1985-08-08
2 products
MVC PLUSAllerganN-018439 DISCN1985-08-08
1 products
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.I.-12 ADULTHospiraN-008809 DISCN2004-04-22
1 products
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Phytonadione
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.I. PEDIATRICHospiraN-018920 DISCN2000-09-21
1 products, RLD
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
+
Vitamin k
Tradename
Company
Number
Date
Products
M.V.I. ADULTHospiraN-021625 DISCN2004-01-30
1 products, RLD
M.V.I. ADULT (PHARMACY BULK PACKAGE)HospiraN-021643 DISCN2004-02-18
1 products, RLD
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pantothenic acid
+
Phytonadione
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Vitamin a palmitate
+
Vitamin e
Tradename
Company
Number
Date
Products
VITAPEDHospiraN-020176 DISCN1993-12-29
1 products
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin 5'-phosphate sodium
+
Thiamine
+
Vitamin a
+
Vitamin e
Tradename
Company
Number
Date
Products
M.V.I.-12 LYOPHILIZEDTeligentN-018933 DISCN1985-08-08
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
1.8oz armstrong hand sanitizer with aloe vera and vitamin eOTC monograph not final2017-12-15
2 pack assured instant hand sanitizer with moisturizers (vitamin e and aloe)OTC monograph not final2014-11-02
25 person ansiOTC monograph final2010-06-07
3 hand sanitizersOTC monograph not final2014-11-15
3 pack assured instant hand sanitizer with moisturizers (vitamin e and aloe)OTC monograph not final2014-11-02
3 pack assured instant hand sanitizer with moisturizers (vitamin e and moisturizers)OTC monograph not final2014-11-02
3 pack family dollar instant hand sanitizersOTC monograph not final2014-11-28
5 minoxidil hair foam with biotinC2002632024-10-14
5% minoxidil hair growth foam with biotinC2002632024-10-30
5% minoxidil hair regrowth serum with biotinC2002632024-08-19
Show 450 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemiaHP_0003124D006937—
hypophosphatemiaHP_0002148D017674—
hypertriglyceridemiaEFO_0004211D015228—
peripheral vascular diseasesEFO_0003875D016491I73.9
dermatitisHP_0011123D003872L30.9
alcoholic neuropathyEFO_1000803D020269G62.1
common coldEFO_0007214D003139J00
seizuresHP_0002069D012640G40.4
vitamin a deficiencyEFO_1001237D014802E50
hypoparathyroidismHP_0000829D007011E20
Show 26 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11H: Other plain vitamin preparations in atc
— A11HA: Other plain vitamin preparations in atc
— A11HA05: Biotin
HCPCS
No data
Clinical
Clinical Trials
316 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——520121238
NeoplasmsD009369—C8015513—23
SyndromeD013577——2—1159
MalnutritionD044342EFO_0008572E40-E46—1—326
Myocardial infarctionD009203EFO_0000612I21——1315
InfarctionD007238EFO_0009463———1315
HypertensionD006973EFO_0000537I10——14—5
InfectionsD007239EFO_0000544———1124
St elevation myocardial infarctionD000072657————12—3
Pregnancy rateD018873—————123
Show 18 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230——5123——18
LeukemiaD007938—C95395——16
Neoplasm metastasisD009362EFO_0009708—683——15
Pancreatic neoplasmsD010190EFO_0003860C25582——12
CarcinomaD002277—C80.0544——12
Precursor cell lymphoblastic leukemia-lymphomaD054198——355——12
Stomach neoplasmsD013274EFO_0003897C16472—111
Lymphoid leukemiaD007945—C91244——10
LymphomaD008223—C85.9441——9
SclerosisD012598———24—39
Show 53 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———112——821
Breast neoplasmsD001943EFO_0003869C5051——28
Myeloid leukemiaD007951—C9234———6
Ovarian neoplasmsD010051EFO_0003893C5641——16
Renal cell carcinomaD002292EFO_0000376—52———5
Rectal neoplasmsD012004——15———5
Myeloid leukemia acuteD015470—C92.032———4
MelanomaD008545——41———4
Non-small-cell lung carcinomaD002289——41———4
Liver neoplasmsD008113EFO_1001513C22.022———4
Show 75 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740HP_0001903D64.95———16
ArthritisD001168HP_0001369M05-M144———15
Diabetes mellitusD003920HP_0000819E08-E132———35
Rheumatoid arthritisD001172EFO_0000685M06.94————4
Ovarian epithelial carcinomaD000077216——2———13
PharmacokineticsD010599——1———23
Sickle cell anemiaD000755EFO_0000697D573————3
Hematologic neoplasmsD019337——2————2
Myeloproliferative disordersD009196—D47.12————2
Myelodysplastic-myeloproliferative diseasesD054437——2————2
Show 38 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alopecia areataD000506EFO_0004192L63————99
AlopeciaD000505HP_0002293L64————99
HypotrichosisD007039HP_0008070—————66
InflammationD007249MP_0001845—————33
Vitamin b 12 deficiencyD014806EFO_0000734E53.8————33
ObesityD009765EFO_0001073E66.9————33
Metabolic diseasesD008659EFO_0000589E88.9————22
Retinal diseasesD012164HP_0000479H35.9————22
Autistic disorderD001321HP_0000717F84.0————22
DepressionD003863—F33.9————22
Show 79 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBiotin
INNbiotin
Description
Biotin is an organic heterobicyclic compound that consists of 2-oxohexahydro-1H-thieno[3,4-d]imidazole having a valeric acid substituent attached to the tetrahydrothiophene ring. The parent of the class of biotins. It has a role as a prosthetic group, a coenzyme, a nutraceutical, a human metabolite, a Saccharomyces cerevisiae metabolite, an Escherichia coli metabolite, a mouse metabolite, a cofactor and a fundamental metabolite. It is a member of biotins and a vitamin B7. It is a conjugate acid of a biotinate.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(O)CCCC[C@@H]1SC[C@@H]2NC(=O)N[C@H]12
Identifiers
PDB—
CAS-ID58-85-5
RxCUI—
ChEMBL IDCHEMBL857
ChEBI ID15956
PubChem CID171548
DrugBankDB00121
UNII ID6SO6U10H04 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
UTS2R
UTS2R
Organism
Homo sapiens
Gene name
UTS2R
Gene synonyms
GPR14
NCBI Gene ID
2837
Protein name
urotensin-2 receptor
Protein synonyms
G-protein coupled receptor 14, UR-II-R, Urotensin II receptor
Uniprot ID
Q9UKP6
Mouse ortholog
Uts2r (217369)
urotensin-2 receptor (Q8VIH9)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Biotin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 155,759 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal assure, Citranatal essence, Nestabs, Pnv prenatal plus multivitamin, Pnv prenatal vitamin, Pnv-select, Prenate elite, Prenate enhance, Prenate essential, Prenate mini, Prenate pixie, Prenate restore, Primacare, Select ob, Select-ob plus dha, Vitafol, Vitafol ob, Vitafol-ob plus dha
Adverse Events
Top Adverse Reactions
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977 adverse events reported
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