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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
Patent expiration date
Study first post date
Last update 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
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 biotinC2002632025-09-12
5% minoxidil hair regrowth serum with biotinC2002632025-09-12
5% minoxidil hair regrowth solution with biotinC2002632024-07-25
Show 433 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
hypophosphatemiaHP_0002148D017674—
hypertriglyceridemiaEFO_0004211D015228—
peripheral vascular diseasesEFO_0003875D016491I73.9
dermatitis—D003872L30.9
alcoholic neuropathyEFO_1000803D020269G62.1
common coldEFO_0007214D003139J00
seizures—D012640G40.4
vitamin a deficiencyEFO_1001237D014802E50
hypoparathyroidism—D007011E20
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
189 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C805——3—8
MalnutritionD044342EFO_0008572E40-E46—1—326
Pregnancy rateD018873—————123
InfectionsD007239EFO_0000544————123
Severe acute respiratory syndromeD045169EFO_0000694J12.81———112
Colorectal neoplasmsD015179——11—1—2
OsteoporosisD010024EFO_0003882M81.0——11—2
Essential hypertensionD000075222—I10———112
ExanthemaD005076—————1—1
Fetal nutrition disordersD048070—————1—1
Show 12 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SclerosisD012598———23—27
Multiple sclerosisD009103EFO_0003885G35——3—36
Chronic kidney failureD007676EFO_0003884N18.6——1—34
Chronic progressive multiple sclerosisD020528EFO_0003840———2—24
Covid-19D000086382—U07.11—1—13
PneumoniaD011014EFO_0003106J18—11—13
Septic shockD012772—A48.3—11—13
AvitaminosisD001361EFO_0005878E56.9——1—12
Chronic renal insufficiencyD051436—N18—11—12
DeathD003643PATO_0001422——11—12
Show 26 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———52——714
AnemiaD000740EFO_0004272D64.951——28
Type 2 diabetes mellitusD003924EFO_0001360E11—1——45
Myeloid leukemia acuteD015470—C92.032———4
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.032———4
Sickle cell anemiaD000755EFO_0000697D5731———4
Pancreatic neoplasmsD010190EFO_0003860C2512———3
Myelodysplastic syndromesD009190—D4621———3
Myelomonocytic leukemia chronicD015477—C93.121———3
SepsisD018805EFO_0001420A41.9—1——23
Show 55 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—1———45
Diabetes mellitusD003920EFO_0000400E08-E132———35
Breast neoplasmsD001943EFO_0003869C502———24
Neoplasm metastasisD009362EFO_0009708—3————3
Hematologic neoplasmsD019337——2————2
Myeloproliferative disordersD009196—D47.12————2
Non-hodgkin lymphomaD008228—C85.92————2
Myelodysplastic-myeloproliferative diseasesD054437——2————2
Prostatic neoplasmsD011471—C611————1
Castration-resistant prostatic neoplasmsD064129——1————1
Show 21 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlopeciaD000505—L64————99
Alopecia areataD000506EFO_0004192L63————77
HypotrichosisD007039——————44
Vitamin b 12 deficiencyD014806EFO_0000734E53.8————33
ObesityD009765EFO_0001073E66.9————33
Metabolic diseasesD008659EFO_0000589E88.9————22
PharmacokineticsD010599——————22
Autistic disorderD001321EFO_0003758F84.0————22
DepressionD003863—F33.9————22
Heart failureD006333EFO_0003144I50————22
Show 93 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 174,225 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, Select ob, Select-ob plus dha, Vitafol, Vitafol ob, Vitafol-ob plus dha
Adverse Events
Top Adverse Reactions
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1,183 adverse events reported
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