ivermectin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiparasitics, ivermectin derivatives 3972 70288-86-7

Description:

MoleculeDescription

Synonyms:

  • ivermectin
  • noramectin
  • noromectin
  • zimecterin
A mixture of mostly avermectin H2B1a (RN 71827-03-7) with some avermectin H2B1b (RN 70209-81-3), which are macrolides from STREPTOMYCES avermitilis. It binds glutamate-gated chloride channel to cause increased permeability and hyperpolarization of nerve and muscle cells. It also interacts with other CHLORIDE CHANNELS. It is a broad spectrum antiparasitic that is active against microfilariae of ONCHOCERCA VOLVULUS but not the adult form. In vitro data suggest evidence of activity against SARS-CoV-2, but to date available data are insufficient to recommend either for or against the use of ivermectin for the treatment of COVID-19. FDA issued a warning concerning possi-ble inappropriate use of ivermectin products intended for animals as an attempt to self-medicate for the treat-ment of COVID-19.
  • Molecular weight: 1736.19
  • Formula: C95H146O28
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
12 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 4 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.17 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Nov. 22, 1996 FDA MERCK SHARP DOHME

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Conjunctival haemorrhage 269.98 25.18 60 4329 3527 63481106
Ocular hyperaemia 172.60 25.18 65 4324 25079 63459554
Asthenia 154.33 25.18 159 4230 383445 63101188
Headache 145.82 25.18 197 4192 633044 62851589
Vertigo 144.07 25.18 74 4315 59813 63424820
Malaria 109.43 25.18 18 4371 202 63484431
Somatic delusion 85.57 25.18 17 4372 575 63484058
Skin irritation 77.13 25.18 28 4361 9713 63474920
Coma 75.65 25.18 50 4339 64314 63420319
Pyrexia 68.75 25.18 119 4270 470359 63014274
Encephalopathy 60.45 25.18 36 4353 38584 63446049
Logorrhoea 56.59 25.18 16 4373 2494 63482139
Abnormal faeces 51.91 25.18 18 4371 5462 63479171
Skin burning sensation 49.74 25.18 22 4367 12712 63471921
Depressed level of consciousness 49.30 25.18 38 4351 62040 63422593
Gastrointestinal motility disorder 49.21 25.18 17 4372 5102 63479531
Product use in unapproved indication 45.76 25.18 59 4330 179021 63305612
Urine odour abnormal 45.53 25.18 17 4372 6372 63478261
Erythema 45.05 25.18 58 4331 175693 63308940
Oral discomfort 42.84 25.18 18 4371 9183 63475450
Urinary incontinence 37.88 25.18 25 4364 31989 63452644
Pruritus 34.96 25.18 77 4312 361376 63123257
Dermatitis contact 33.52 25.18 16 4373 10992 63473641
Acute generalised exanthematous pustulosis 33.39 25.18 16 4373 11083 63473550
Chromaturia 32.61 25.18 18 4371 16699 63467934
Musculoskeletal discomfort 31.40 25.18 18 4371 17949 63466684
Rash papular 30.89 25.18 17 4372 15685 63468948
Off label use 29.78 25.18 108 4281 674354 62810279
Language disorder 28.05 25.18 9 4380 2151 63482482
Aphasia 27.94 25.18 21 4368 32979 63451654
Vascular purpura 26.99 25.18 8 4381 1470 63483163
Abnormal behaviour 26.00 25.18 17 4372 21409 63463224
Cheilitis 25.90 25.18 10 4379 4103 63480530
Mazzotti reaction 25.74 25.18 3 4386 0 63484633

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Conjunctival haemorrhage 878.04 34.77 180 5694 2875 34948182
Ocular hyperaemia 623.33 34.77 176 5698 11276 34939781
Asthenia 483.75 34.77 366 5508 244885 34706172
Headache 464.15 34.77 330 5544 200305 34750752
Coma 417.33 34.77 186 5688 45492 34905565
Vertigo 295.25 34.77 123 5751 25413 34925644
Pyrexia 258.04 34.77 296 5578 332717 34618340
Urinary incontinence 242.16 34.77 98 5776 18776 34932281
Malaria 225.19 34.77 38 5836 185 34950872
Back pain 158.74 34.77 144 5730 121645 34829412
Encephalopathy 153.10 34.77 87 5787 35232 34915825
Gait disturbance 141.97 34.77 116 5758 85024 34866033
Depressed level of consciousness 99.05 34.77 71 5803 42770 34908287
Abnormal behaviour 88.37 34.77 54 5820 24915 34926142
Language disorder 80.15 34.77 25 5849 2231 34948826
Myalgia 68.01 34.77 77 5797 84033 34867024
Nuchal rigidity 62.70 34.77 15 5859 491 34950566
Logorrhoea 62.22 34.77 21 5853 2405 34948652
Arthralgia 58.12 34.77 103 5771 169938 34781119
Rhinocerebral mucormycosis 55.95 34.77 14 5860 554 34950503
Filariasis 53.85 34.77 7 5867 0 34951057
Anal incontinence 52.88 34.77 26 5848 7823 34943234
Adverse event 52.29 34.77 35 5839 18842 34932215
Pruritus 51.07 34.77 88 5786 141893 34809164
Stupor 47.53 34.77 18 5856 2873 34948184
Product use in unapproved indication 46.45 34.77 76 5798 117423 34833634
Blood smear test abnormal 46.15 34.77 6 5868 0 34951057
Chills 44.28 34.77 61 5813 80982 34870075
Strongyloidiasis 41.42 34.77 16 5858 2695 34948362

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Conjunctival haemorrhage 1124.02 25.63 234 9511 5631 79729012
Ocular hyperaemia 742.24 25.63 230 9515 27976 79706667
Asthenia 629.12 25.63 508 9237 511181 79223462
Headache 491.16 25.63 492 9253 653280 79081363
Coma 461.26 25.63 231 9514 100418 79634225
Vertigo 405.51 25.63 188 9557 68894 79665749
Malaria 335.66 25.63 56 9689 366 79734277
Pyrexia 320.76 25.63 402 9343 678307 79056336
Urinary incontinence 267.07 25.63 120 9625 40789 79693854
Encephalopathy 215.75 25.63 122 9623 67275 79667368
Depressed level of consciousness 141.08 25.63 107 9638 96545 79638098
Back pain 138.99 25.63 178 9567 304002 79430641
Gait disturbance 133.93 25.63 145 9600 207361 79527282
Abnormal behaviour 130.32 25.63 71 9674 36350 79698293
Language disorder 118.12 25.63 34 9711 3180 79731463
Logorrhoea 116.23 25.63 36 9709 4329 79730314
Somatic delusion 77.93 25.63 18 9727 700 79733943
Product use in unapproved indication 73.64 25.63 119 9626 250240 79484403
Rhinocerebral mucormycosis 71.00 25.63 18 9727 1040 79733603
Strongyloidiasis 70.58 25.63 24 9721 3874 79730769
Nuchal rigidity 70.23 25.63 18 9727 1086 79733557
Pruritus 70.12 25.63 151 9594 394497 79340146
Myalgia 69.85 25.63 99 9646 185542 79549101
Anal incontinence 58.33 25.63 33 9712 18135 79716508
Filariasis 56.07 25.63 7 9738 0 79734643
Agitation 52.82 25.63 63 9682 99652 79634991
Stupor 50.71 25.63 22 9723 6850 79727793
Chills 49.56 25.63 78 9667 160156 79574487
Aphasia 45.60 25.63 41 9704 46691 79687952
Eosinophilia 42.70 25.63 39 9706 45306 79689337
Adverse event 40.33 25.63 43 9702 60171 79674472
Speech disorder 38.46 25.63 40 9705 54405 79680238
Blood smear test abnormal 37.15 25.63 6 9739 31 79734612
Gastrointestinal motility disorder 36.86 25.63 17 9728 6105 79728538
Dysstasia 36.67 25.63 29 9716 27717 79706926
Urine odour abnormal 36.46 25.63 17 9728 6256 79728387
Decubitus ulcer 36.09 25.63 23 9722 15664 79718979
Loss of consciousness 35.31 25.63 69 9676 167874 79566769
Abnormal faeces 33.43 25.63 17 9728 7554 79727089
Off label use 32.97 25.63 206 9539 907009 78827634
Skin irritation 32.30 25.63 19 9726 11221 79723422
Oral discomfort 32.06 25.63 18 9727 9742 79724901
Mazzotti reaction 32.04 25.63 4 9741 0 79734643
Diarrhoea 32.03 25.63 200 9545 880289 78854354
Skin burning sensation 31.88 25.63 20 9725 13252 79721391
Fall 31.87 25.63 10 9735 487619 79247024
Disseminated strongyloidiasis 30.88 25.63 7 9738 250 79734393
Fatigue 30.09 25.63 42 9703 929685 78804958
Disorientation 27.37 25.63 36 9709 62740 79671903
Eyelid oedema 26.45 25.63 18 9727 13669 79720974
Paresis 26.18 25.63 12 9733 4249 79730394
Conjunctival hyperaemia 25.78 25.63 12 9733 4401 79730242

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D11AX22 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
ATC P02CF01 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTHELMINTICS
ANTINEMATODAL AGENTS
Avermectines
FDA EPC N0000175484 Antiparasitic
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D007306 Insecticides
MeSH PA D010575 Pesticides
CHEBI has role CHEBI:24852 insecticides
CHEBI has role CHEBI:35443 anthelmintics
CHEBI has role CHEBI:35444 antinematodal drugs
CHEBI has role CHEBI:35820 antiprotozoal drugs
CHEBI has role CHEBI:73333 scabicides
FDA EPC N0000181811 Pediculicide

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Infection by Strongyloides indication 1214006 DOID:10955
Infection by Onchocerca volvulus indication 38539003 DOID:11678
Infection by Loa loa contraindication 44250009 DOID:13523
Liver function tests abnormal contraindication 166603001




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Bison Treatment and control of grubs, Hypoderma bovis Indication
Cats Prevents heartworm disease Indication
Cats Removal and control of adult and immature (L4) hookworms, Ancylostoma tubaeforme Indication
Cats Removal and control of adult and immature (L4) hookworms, A braziliense Indication
Cats Treatment of adult ear mite (Otodectes cynotis) Indication
Cattle Treatment and control of gastrointestinal nematodes, Haemonchus placei (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, Ostertagia ostertagi (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, O lyrata (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, Trichostrongylus axei (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, T colubriformis (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, Cooperia oncophora (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, C punctata (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, C pectinata (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, Oesophagostomum radiatum (adults and fourth-stage larvae) Indication
Cattle Treatment and control of gastrointestinal nematodes, Nematodirus helvetianus (adults) Indication
Cattle Treatment and control of gastrointestinal nematodes, N spathiger (adults) Indication
Cattle Treatment and control of gastrointestinal nematodes, Bunostomum phlebotomum (adults and fourth-stage larvae) Indication
Cattle Treatment and control of lungworms, Dictyocaulus viviparus, (adult and L4) Indication
Cattle Treatment and control of grubs, Hypoderma bovis Indication
Cattle Treatment and control of grubs, H lineatum Indication
Cattle Treatment and control of sucking lice, Linognathus vituli Indication
Cattle Treatment and control of sucking lice Haematopinus eurysternus Indication
Cattle Treatment and control of sucking lice, Solenopotes capillatus Indication
Cattle Treatment and control of mites, Psoroptes ovis Indication
Cattle Treatment and control of mites, Sarcoptes scabiei var bovis Indication
Cattle Protection (28 days) from reinfection with D viviparus Indication
Cattle Protection (28 days) from reinfection with O radiatum Indication
Cattle Protection (21 days) from reinfection with O ostertagi Indication
Cattle Protection (21 days) from reinfection with T axei Indication
Cattle Protection (21 days) from reinfection with C punctata Indication
Cattle Protection (14 days) from reinfection with H placei Indication
Cattle Protection (14 days) from reinfection with C oncophora Indication
Cervidae Treatment and control of warbles, Oedemagena tarandi Indication
Dogs Prevention of heartworm disease Indication
Foxes Ear mite (Otodectes cynotis) infestations Indication
Horses Treatment and control of large strongyles, Strongylus vulgaris (adults) Indication
Horses Treatment and control of large strongyles, S edentatus (adults) Indication
Horses Treatment and control of large strongyles, S equinus Indication
Horses Treatment and control of large strongyles, Triodontophorus spp (adults) Indication
Horses Treatment and control of large strongyles, Craterostomum acuticaudatum (adults) Indication
Horses Treatment and control of small strongyles, Coronocyclus spp (adults) Indication
Horses Treatment and control of small strongyles, Cyathostomum spp (adults) Indication
Horses Treatment and control of small strongyles, Cylicocyclus spp (adults) Indication
Horses Treatment and control of small strongyles, Cylicodontophorus spp (adults) Indication
Horses Treatment and control of small strongyles, Cylicostephanus spp (adults) Indication
Horses Treatment and control of small strongyles, Petrovinema poculatum (adults) Indication
Horses Indication
Horses Treatment and control of small strongyles, (fourth-stage larvae) Indication
Horses Treatment and control of pinworms Oxyuris equi (adults and fourth stage larvae) Indication
Horses Treatment and control of ascarids (adults and third- and fourth-stage larvae) Parascaris equorum Indication
Horses Treatment and control of Hairworms, Trichostrongylus axei (adults) Indication
Horses Treatment and control of Large mouth Stomach Worms, Habronema muscae (adults) Indication
Horses Treatment and control of bots, (oral and gastric stages) Gasterophilus spp Indication
Horses Treatment and control of Lungworms, Dictyocaulus arnfieldi (adults and fourth-stage larvae) Indication
Horses Treatment and control of Intestinal Threadworms, Strongyloides westeri (adults) Indication
Horses Summer sores caused by Habronema Indication
Horses Summer sores caused by Draschia spp cutaneous third-stage larvae Indication
Horses Dermatitis caused by neck threadworm microfilariae, Onchocerca sp Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, Haemonchus contortus Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, H placei (adults only) Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, Ostertagia circumcincta Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, Trichostrongylus axei Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, T colubriformis Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, Cooperia oncophora (adults only) Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, C curticei Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, Oesophagostomum columbianum Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, O venulosum (adults only) Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, Nematodirus battus Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, N spathiger Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, S papillosus (adults only) Indication
Sheep Treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms, Chabertia ovina (adult only) Indication
Sheep Treatment and control of the gastrointestinal roundworms, Trichuris ovis (adults only) Indication
Sheep Treatment and control of the nasal bot, Oestrus ovis Indication
Sheep Treatment and control of lungworms, D filaria Indication
Swine Treatment and control of gastrointestinal roundworms, Ascaris suum (adults and fourth-stage larvae) Indication
Swine Treatment and control of gastrointestinal roundworms, Ascarops strongylina (adults) Indication
Swine Treatment and control of gastrointestinal roundworms, Hyostrongylus rubidus (adults and fourth-stage larvae) Indication
Swine Treatment and control of gastrointestinal roundworms, Oesophagostomum species (adults and fourth-stage larvae) Indication
Swine Treatment and control of kidneyworms, Stephanurus dentatus (adults and fourth-stage larvae) Indication
Swine Treatment and control of lungworms, Metastrongylus species (adults) Indication
Swine Treatment and control of lice, Haematopinus suis Indication
Swine Treatment and control of mange mites, Sarcoptes scabiei var suis Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Eqvalan Injection Boehringer lngelheim Animal Health USA Inc. 1
Ivomec .27% Injection Grower And Feeder Pigs, Ivomec 1% Injection, Ivomec 1% Injection for Cattle And Swine, Ivomec Injection for Cattle Boehringer lngelheim Animal Health USA Inc. 1
Ivomec Liquid Boehringer lngelheim Animal Health USA Inc. 1
EQVALAN Boehringer lngelheim Animal Health USA Inc. 1
Ivomec Cattle Paste 0.153% Boehringer lngelheim Animal Health USA Inc. 1
Heartgard 30, Heartgard Tablets Boehringer lngelheim Animal Health USA Inc. 1
Eqvalan Oral Liquid For Horses Boehringer lngelheim Animal Health USA Inc. 1
Ivomec Plus Injection For Cattle Boehringer lngelheim Animal Health USA Inc. 2
Ivomec Pour-On Boehringer lngelheim Animal Health USA Inc. 1
Heartgard Chewables For Dogs Boehringer lngelheim Animal Health USA Inc. 1
Heartgard Plus Boehringer lngelheim Animal Health USA Inc. 2
Ivomec Premix for Swine Boehringer lngelheim Animal Health USA Inc. 1
Ivomec Sustained-Release Bolus for Cattle Boehringer lngelheim Animal Health USA Inc. 1
Heartgard for Cats Boehringer lngelheim Animal Health USA Inc. 1
BMD / Ivomec Premix for Swine Boehringer lngelheim Animal Health USA Inc. 2
Acarexx Boehringer lngelheim Animal Health USA Inc. 1
Advantage DUO Elanco US Inc. 2
ZIMECTERIN Gold Paste Boehringer lngelheim Animal Health USA Inc. 2
Equimax Virbac AH Inc. 2
Zimecterin-EZ Farnam Companies Inc. 1
Iverhart Max Virbac AH Inc. 3
Panacur Plus Intervet Inc. 3
Duocare Boehringer lngelheim Animal Health USA Inc. 2
IVERHART MAX Chew Virbac AH Inc. 3
Phoenectin Elanco US Inc. 1
Ivermectin Pour-On for Cattle, Phoenectin, Phoenectin, Phoenectin Pour-On for Cattle Huvepharma EOOD 1
Phoenectin Huvepharma EOOD 1
Iverhart Tablets Virbac AH Inc. 1
Noromectin Pour-On for Cattle Norbrook Laboratories, Ltd. 1
Phoenectin Paste 1.87% Elanco US Inc. 1
Iversol Liquid for Horses Med-Pharmex Inc. 1
Ivermectin Chewable Tablets Cronus Pharma Specialities India Private Limited 1
Iver-On Med-Pharmex Inc. 1
Iverhart Plus Flavored Chewables Virbac AH Inc. 2
Bimectin Pour-On Bimeda Animal Health Limited 1
Equell Virbac AH Inc. 1
Primectin Equine Oral Liquid First Priority Inc. 1
Bimectin Bimeda Animal Health Limited 1
Privermectin Drench for Sheep First Priority Inc. 1
Tri-Heart Plus Chewable Tablets Heska Corp. 2
Privermectin First Priority Inc. 1
SparMectin-E Sparhawk Laboratories Inc. 1
Ecomectin Huvepharma EOOD 1
Ivermectin Paste 1.87 % Med-Pharmex Inc. 1
Ivermectin Injection Sparhawk Laboratories Inc. 1
Normectin Plus Norbrook Laboratories, Ltd. 2
Noromectin Norbrook Laboratories, Ltd. 1
Bimectin Injection for Cattle and Swine Bimeda Animal Health Limited 1
Bimectin Plus Bimeda Animal Health Limited 2
SparMectin Plus Clorsulon Sparhawk Laboratories Inc. 2
Animec Plus Chanelle Pharmaceuticals Manufacturing Ltd. 1
Ivermectin Paste 1.87% Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 7550440 April 22, 2024 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 8080530 April 22, 2024 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 8093219 April 22, 2024 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 8415311 April 22, 2024 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 8470788 April 22, 2024 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 8815816 April 22, 2024 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 10206939 March 13, 2034 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 9089587 March 13, 2034 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 9233117 March 13, 2034 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 9233118 March 13, 2034 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
1% SOOLANTRA GALDERMA LABS LP N206255 Dec. 19, 2014 RX CREAM TOPICAL 9782425 March 13, 2034 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Multidrug resistance protein 1 Transporter IC50 7 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Ki 5.41 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.13 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 5.92 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 5.89 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 5.59 DRUG MATRIX
Alpha-2C adrenergic receptor GPCR Ki 6.24 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.45 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 6.54 DRUG MATRIX
Neuronal acetylcholine receptor subunit alpha-7 Ion channel ALLOSTERIC MODULATOR EC50 5.10 IUPHAR
Bile acid receptor Nuclear hormone receptor IC50 6.59 CHEMBL
Glycine Receptor Ion channel AGONIST EC50 6.40 IUPHAR
D(1A) dopamine receptor GPCR Ki 5.65 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR Ki 5.66 DRUG MATRIX
Glutamate-gated chloride channel Ion channel MODULATOR CHEMBL CHEMBL
Glutamate-gated chloride channel Ion channel MODULATOR CHEMBL CHEMBL
Sarcoplasmic/endoplasmic reticulum calcium ATPase 2 Enzyme IC50 5.17 CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-1 Enzyme IC50 5.08 CHEMBL
Sarcoplasmic/endoplasmic reticulum calcium ATPase 1 Enzyme IC50 4.77 CHEMBL
P2X purinoceptor 4 Ion channel ALLOSTERIC MODULATOR EC50 6.60 IUPHAR

External reference:

IDSource
4021046 VUID
N0000148510 NUI
D00804 KEGG_DRUG
4021046 VANDF
C0022322 UMLSCUI
CHEBI:6078 CHEBI
IVM PDB_CHEM_ID
CHEMBL1200633 ChEMBL_ID
D007559 MESH_DESCRIPTOR_UI
DB00602 DRUGBANK_ID
2373 IUPHAR_LIGAND_ID
4828 INN_ID
8883YP2R6D UNII
6321424 PUBCHEM_CID
6069 RXNORM
4941 MMSL
71965 MMSL
d04101 MMSL
005266 NDDF
387559003 SNOMEDCT_US
96138006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
STROMECTOL HUMAN PRESCRIPTION DRUG LABEL 1 0006-0032 TABLET 3 mg ORAL NDA 26 sections
STROMECTOL HUMAN PRESCRIPTION DRUG LABEL 1 0006-0032 TABLET 3 mg ORAL NDA 26 sections
SOOLANTRA HUMAN PRESCRIPTION DRUG LABEL 1 0299-3823 CREAM 10 mg TOPICAL NDA 27 sections
SOOLANTRA HUMAN PRESCRIPTION DRUG LABEL 1 0299-3823 CREAM 10 mg TOPICAL NDA 27 sections
Ivermectin HUMAN OTC DRUG LABEL 1 0363-4230 LOTION 5 mg TOPICAL ANDA 16 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 0574-2107 CREAM 10 mg TOPICAL NDA authorized generic 27 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 0574-2107 CREAM 10 mg TOPICAL NDA authorized generic 27 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 0574-2107 CREAM 10 mg TOPICAL NDA authorized generic 27 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 0591-4052 CREAM 10 mg TOPICAL ANDA 26 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 0591-4052 CREAM 10 mg TOPICAL ANDA 26 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 0591-4052 CREAM 10 mg TOPICAL ANDA 26 sections
Ivermectin HUMAN OTC DRUG LABEL 1 11822-4230 LOTION 5 mg TOPICAL ANDA 16 sections
Sklice HUMAN OTC DRUG LABEL 1 24338-185 LOTION 5 mg TOPICAL NDA 16 sections
Sklice HUMAN OTC DRUG LABEL 1 24338-185 LOTION 5 mg TOPICAL NDA 16 sections
Ivermectin Human Prescription Drug Label 1 42799-806 TABLET 3 mg ORAL ANDA 25 sections
Ivermectin Human Prescription Drug Label 1 42799-806 TABLET 3 mg ORAL ANDA 25 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 50090-5587 TABLET 3 mg ORAL ANDA 24 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 50090-5587 TABLET 3 mg ORAL ANDA 24 sections
Ivermectin HUMAN OTC DRUG LABEL 1 51316-423 LOTION 5 mg TOPICAL ANDA 16 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 51672-4211 LOTION 5 mg TOPICAL ANDA 27 sections
Ivermectin HUMAN OTC DRUG LABEL 1 51672-4230 LOTION 5 mg TOPICAL ANDA 17 sections
Ivermectin HUMAN OTC DRUG LABEL 1 51672-4230 LOTION 5 mg TOPICAL ANDA 17 sections
STROMECTOL HUMAN PRESCRIPTION DRUG LABEL 1 55695-019 TABLET 3 mg ORAL NDA 26 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 63629-8754 CREAM 10 mg TOPICAL ANDA 25 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 63629-8754 CREAM 10 mg TOPICAL ANDA 25 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 63629-8754 CREAM 10 mg TOPICAL ANDA 25 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 66993-948 CREAM 10 mg TOPICAL NDA authorized generic 26 sections
Ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 68071-2242 TABLET 3 mg ORAL ANDA 25 sections
ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 70771-1728 CREAM 10 mg TOPICAL ANDA 2 sections
ivermectin HUMAN PRESCRIPTION DRUG LABEL 1 72578-120 CREAM 10 mg TOPICAL ANDA 24 sections