teriflunomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4634 163451-81-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • HMR1726
  • flucyamide
  • aubagio
  • teriflunomide
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.
  • Molecular weight: 270.21
  • Formula: C12H9F3N2O2
  • CLOGP: 2.33
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 73.12
  • ALOGS: -4.34
  • ROTB: 3

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
14 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 0.16 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.01 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 350 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 26, 2013 EMA
Sept. 12, 2012 FDA SANOFI AVENTIS US

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
Multiple sclerosis relapse 2417.44 16.79 875 24059 42089 50538101
Alopecia 1254.93 16.79 1002 23932 244045 50336145
Paraesthesia 524.73 16.79 450 24484 119793 50460397
Hypoaesthesia 500.63 16.79 449 24485 126808 50453382
Product dose omission issue 434.43 16.79 492 24442 183346 50396844
Diarrhoea 234.18 16.79 726 24208 587750 49992440
Gait disturbance 196.63 16.79 301 24633 149704 50430486
Balance disorder 186.94 16.79 201 24733 70389 50509801
Product dose omission in error 165.14 16.79 57 24877 2343 50577847
Fall 153.12 16.79 435 24499 334497 50245693
Unevaluable event 132.25 16.79 137 24797 45929 50534261
Memory impairment 125.23 16.79 174 24760 79186 50501004
Bladder disorder 113.47 16.79 61 24873 7482 50572708
Off label use 112.07 16.79 47 24887 474379 50105811
Depression 108.91 16.79 247 24687 165176 50415014
Fatigue 104.13 16.79 648 24286 706953 49873237
Depressed mood 100.91 16.79 103 24831 33920 50546270
Multiple sclerosis 99.95 16.79 82 24852 20411 50559779
Optic neuritis 98.85 16.79 54 24880 6836 50573354
Muscular weakness 89.96 16.79 165 24769 94848 50485342
COVID-19 80.67 16.79 107 24827 46555 50533635
Toxicity to various agents 73.80 16.79 9 24925 212490 50367700
Acute kidney injury 73.73 16.79 12 24922 228046 50352144
Headache 72.37 16.79 461 24473 506074 50074116
Rheumatoid arthritis 71.78 16.79 8 24926 202542 50377648
Visual impairment 70.27 16.79 123 24811 68152 50512038
Drug hypersensitivity 69.31 16.79 19 24915 250991 50329199
Limb discomfort 69.07 16.79 72 24862 24285 50555905
JC polyomavirus test positive 67.34 16.79 24 24910 1085 50579105
Central nervous system lesion 66.18 16.79 47 24887 9442 50570748
Muscle spasticity 64.06 16.79 59 24875 17125 50563065
Mobility decreased 61.22 16.79 127 24807 79821 50500369
Sensory disturbance 61.19 16.79 49 24885 11780 50568410
Condition aggravated 56.46 16.79 292 24642 296766 50283424
Burning sensation 56.30 16.79 89 24845 45357 50534833
Completed suicide 52.84 16.79 3 24931 131886 50448304
Magnetic resonance imaging abnormal 52.47 16.79 26 24908 2692 50577498
Maternal exposure during pregnancy 50.30 16.79 9 24925 159769 50420421
Therapeutic product effect decreased 49.13 16.79 5 24929 136045 50444145
Synovitis 49.06 16.79 3 24931 123862 50456328
Urinary incontinence 47.68 16.79 64 24870 28144 50552046
Cognitive disorder 44.74 16.79 79 24855 44044 50536146
Throat clearing 40.72 16.79 17 24917 1181 50579009
Injection site pain 40.29 16.79 4 24930 111020 50469170
Joint swelling 40.20 16.79 37 24897 245249 50334941
Decreased interest 39.06 16.79 22 24912 2954 50577236
Feeling abnormal 38.86 16.79 143 24791 125349 50454841
Electric shock sensation 38.76 16.79 11 24923 234 50579956
Systemic lupus erythematosus 38.11 16.79 11 24923 140611 50439579
Micturition urgency 38.06 16.79 32 24902 8232 50571958
Drug interaction 37.87 16.79 26 24908 199595 50380595
Lymphopenia 36.99 16.79 42 24892 15579 50564611
Hypotension 36.86 16.79 37 24897 235432 50344758
Hyponatraemia 36.13 16.79 3 24931 96136 50484054
Death 35.92 16.79 66 24868 325313 50254877
Overdose 35.15 16.79 4 24930 99723 50480467
Exposure during pregnancy 35.06 16.79 135 24799 120880 50459310
Breast cancer 33.83 16.79 69 24865 42821 50537369
Incontinence 32.85 16.79 32 24902 9953 50570237
Anaemia 32.75 16.79 46 24888 252410 50327780
Walking aid user 31.90 16.79 26 24908 6407 50573783
Muscle spasms 30.00 16.79 132 24802 125421 50454769
Peroneal nerve palsy 29.37 16.79 21 24913 4262 50575928
Lower respiratory tract infection 28.60 16.79 6 24928 95195 50484995
Pericarditis 28.12 16.79 3 24931 78686 50501504
Vision blurred 28.11 16.79 94 24840 78553 50501637
Hepatic enzyme increased 28.09 16.79 138 24796 137242 50442948
Onychoclasis 27.89 16.79 22 24912 5174 50575016
Pneumonia 27.56 16.79 95 24839 378306 50201884
Stress 27.51 16.79 73 24861 53720 50526470
Wound 27.36 16.79 9 24925 105785 50474405
Secondary progressive multiple sclerosis 27.11 16.79 13 24921 1253 50578937
Hypertension 25.64 16.79 185 24749 211018 50369172
Therapeutic product effect incomplete 25.08 16.79 7 24927 91508 50488682
Intentional product use issue 24.93 16.79 4 24930 76914 50503276
Lipase increased 23.76 16.79 25 24909 8516 50571674
Paraparesis 23.73 16.79 14 24920 2050 50578140
SARS-CoV-2 test positive 23.46 16.79 19 24915 4640 50575550
Pain in extremity 23.44 16.79 221 24713 272644 50307546
Respiratory failure 23.15 16.79 8 24926 91173 50489017
Hair texture abnormal 22.97 16.79 17 24917 3639 50576551
Heteroplasia 22.42 16.79 4 24930 7 50580183
Arthropathy 22.28 16.79 27 24907 157879 50422311
Pancytopenia 21.99 16.79 7 24927 84023 50496167
Weight decreased 21.98 16.79 185 24749 221060 50359130
Blood pressure increased 21.92 16.79 126 24808 133006 50447184
Haemoglobin decreased 21.04 16.79 19 24915 127197 50452993
Dysstasia 20.83 16.79 34 24900 17785 50562405
Trigeminal neuralgia 20.73 16.79 15 24919 3100 50577090
Hemiparesis 20.45 16.79 36 24898 20012 50560178
Hypokalaemia 20.23 16.79 9 24925 87983 50492207
General physical health deterioration 19.42 16.79 25 24909 142409 50437781
Pleural effusion 19.25 16.79 8 24926 81446 50498744
Paternal exposure timing unspecified 19.15 16.79 4 24930 21 50580169
Temperature intolerance 19.10 16.79 21 24913 7518 50572672
Cardiac failure congestive 18.83 16.79 9 24925 84373 50495817
Dyspnoea 18.80 16.79 176 24758 547432 50032758
Liver function test increased 18.79 16.79 40 24894 25566 50554624
Spinal operation 18.63 16.79 19 24915 6241 50573949
Asthenia 18.46 16.79 239 24695 318803 50261387
Pollakiuria 18.36 16.79 38 24896 23813 50556377
Abortion 18.32 16.79 12 24922 2112 50578078
Neuralgia 18.22 16.79 36 24898 21827 50558363
Neutropenia 18.15 16.79 28 24906 147937 50432253
Band sensation 17.61 16.79 8 24926 682 50579508
Impaired driving ability 17.55 16.79 15 24919 3946 50576244
Swelling 17.03 16.79 47 24887 200825 50379365
Pharyngeal abscess 16.99 16.79 6 24928 264 50579926
Treatment failure 16.93 16.79 26 24908 137611 50442579
Progressive multiple sclerosis 16.92 16.79 8 24926 747 50579443
Hypoglycaemia 16.89 16.79 3 24931 53578 50526612

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
Multiple sclerosis relapse 902.89 26.35 235 4723 11184 29558385
Alopecia 207.60 26.35 88 4870 18996 29550573
Product dose omission issue 154.34 26.35 128 4830 96255 29473314
Gait disturbance 102.05 26.35 90 4868 73259 29496310
Hypoaesthesia 100.21 26.35 78 4880 53389 29516180
Paraesthesia 97.55 26.35 77 4881 53768 29515801
Multiple sclerosis 82.22 26.35 32 4926 5522 29564047
Diarrhoea 69.86 26.35 164 4794 332534 29237035
Balance disorder 66.02 26.35 52 4906 36118 29533451
Product dose omission in error 63.62 26.35 16 4942 648 29568921
Fatigue 63.01 26.35 153 4805 316668 29252901
Fall 54.08 26.35 102 4856 177076 29392493
Mobility decreased 44.74 26.35 36 4922 25744 29543825
Headache 43.25 26.35 92 4866 173915 29395654
Memory impairment 39.49 26.35 39 4919 36431 29533138
Optic neuritis 35.94 26.35 15 4943 3094 29566475
Visual impairment 34.46 26.35 33 4925 29675 29539894
Unevaluable event 32.45 26.35 32 4926 29819 29539750
Depression 30.95 26.35 53 4905 85094 29484475
Meningoencephalitis herpetic 29.35 26.35 9 4949 760 29568809
Trigeminal neuralgia 26.83 26.35 9 4949 1013 29568556
Acute kidney injury 26.60 26.35 6 4952 265261 29304308

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
Multiple sclerosis relapse 2434.62 18.01 813 23506 40322 64434091
Alopecia 1391.70 18.01 830 23489 164860 64309553
Hypoaesthesia 534.33 18.01 432 23887 138676 64335737
Paraesthesia 510.77 18.01 415 23904 134107 64340306
Product dose omission issue 393.66 18.01 423 23896 194324 64280089
Gait disturbance 266.45 18.01 326 23993 171829 64302584
Diarrhoea 234.82 18.01 698 23621 722006 63752407
Balance disorder 197.29 18.01 198 24121 83728 64390685
Fall 167.66 18.01 436 23883 416390 64058023
Fatigue 159.74 18.01 629 23690 748101 63726312
Unevaluable event 158.68 18.01 140 24179 50349 64424064
Memory impairment 150.02 18.01 173 24146 85509 64388904
Product dose omission in error 132.77 18.01 46 24273 2513 64471900
Headache 129.28 18.01 465 23854 529002 63945411
Multiple sclerosis 122.96 18.01 81 24238 18860 64455553
Acute kidney injury 111.51 18.01 18 24301 449222 64025191
Off label use 109.64 18.01 51 24268 632755 63841658
Optic neuritis 107.00 18.01 55 24264 8061 64466352
Toxicity to various agents 106.68 18.01 8 24311 363505 64110908
Depression 99.71 18.01 216 24103 183075 64291338
Visual impairment 96.52 18.01 129 24190 73948 64400465
Muscular weakness 90.73 18.01 168 24151 127170 64347243
Limb discomfort 90.67 18.01 78 24241 27097 64447316
Depressed mood 84.10 18.01 90 24229 40922 64433491
Bladder disorder 83.66 18.01 46 24273 7721 64466692
Mobility decreased 73.75 18.01 123 24196 85717 64388696
Completed suicide 65.60 18.01 5 24314 224409 64250004
Feeling abnormal 65.35 18.01 151 24168 133451 64340962
Muscle spasticity 64.21 18.01 52 24267 16617 64457796
Central nervous system lesion 63.44 18.01 45 24274 11804 64462609
JC polyomavirus test positive 62.83 18.01 22 24297 1240 64473173
Magnetic resonance imaging abnormal 61.92 18.01 28 24291 3095 64471318
Throat clearing 61.57 18.01 22 24297 1316 64473097
Burning sensation 59.39 18.01 83 24236 49581 64424832
Drug interaction 58.32 18.01 32 24287 362051 64112362
Sensory disturbance 56.88 18.01 44 24275 13164 64461249
Hypotension 56.69 18.01 37 24282 380937 64093476
COVID-19 55.48 18.01 93 24226 65047 64409366
Drug hypersensitivity 49.79 18.01 14 24305 237801 64236612
Pain in extremity 48.28 18.01 234 24085 302851 64171562
Condition aggravated 46.63 18.01 269 24050 372157 64102256
Decreased interest 44.95 18.01 23 24296 3337 64471076
Anaemia 44.87 18.01 46 24273 378634 64095779
Secondary progressive multiple sclerosis 44.52 18.01 17 24302 1226 64473187
Hyponatraemia 44.21 18.01 3 24316 148336 64326077
Muscle spasms 44.10 18.01 135 24184 140888 64333525
Walking aid user 43.54 18.01 28 24291 6253 64468160
Electric shock sensation 42.74 18.01 12 24307 324 64474089
Urinary incontinence 42.60 18.01 60 24259 36091 64438322
Rheumatoid arthritis 42.00 18.01 6 24313 164288 64310125
Hepatic enzyme increased 38.41 18.01 122 24197 129821 64344592
Trigeminal neuralgia 37.92 18.01 20 24299 3089 64471324
Pancytopenia 37.18 18.01 5 24314 143304 64331109
Cognitive disorder 37.09 18.01 71 24248 55016 64419397
Lymphopenia 37.00 18.01 47 24272 25610 64448803
Neutropenia 35.97 18.01 23 24296 239601 64234812
Breast cancer 35.27 18.01 49 24270 29099 64445314
Micturition urgency 35.08 18.01 30 24289 10329 64464084
Death 34.83 18.01 82 24237 482623 63991790
Disease progression 34.35 18.01 6 24313 141674 64332739
Pollakiuria 33.74 18.01 50 24269 31480 64442933
Bradycardia 33.51 18.01 3 24316 118216 64356197
Pain 32.57 18.01 335 23984 553176 63921237
Overdose 32.27 18.01 10 24309 159556 64314857
Pneumonia 32.25 18.01 106 24213 559470 63914943
Heteroplasia 31.48 18.01 5 24314 4 64474409
Stress 31.32 18.01 70 24249 60464 64413949
Dysstasia 31.09 18.01 41 24278 23174 64451239
Band sensation 30.78 18.01 11 24308 658 64473755
Impaired driving ability 30.43 18.01 20 24299 4634 64469779
Nausea 30.32 18.01 439 23880 785361 63689052
Renal impairment 30.06 18.01 7 24312 135010 64339403
Weight decreased 29.19 18.01 196 24123 285543 64188870
Haemoglobin decreased 28.89 18.01 19 24300 195044 64279369
Vision blurred 27.78 18.01 86 24233 90230 64384183
Paraparesis 27.77 18.01 17 24302 3485 64470928
Asthenia 27.53 18.01 264 24055 427780 64046633
Incontinence 27.41 18.01 28 24291 12053 64462360
Synovitis 26.82 18.01 3 24316 99087 64375326
Lipase increased 26.72 18.01 30 24289 14372 64460041
Migraine 26.49 18.01 67 24252 62610 64411803
Abdominal discomfort 26.31 18.01 137 24182 182185 64292228
Therapeutic product effect decreased 25.64 18.01 6 24313 115345 64359068
Progressive multiple sclerosis 25.36 18.01 10 24309 786 64473627
Platelet count decreased 25.29 18.01 16 24303 167695 64306718
Lupus vulgaris 25.22 18.01 6 24313 82 64474331
Renal failure 25.19 18.01 19 24300 181669 64292744
Cardiac failure congestive 24.97 18.01 9 24310 130571 64343842
Hair texture abnormal 24.89 18.01 15 24304 2989 64471424
Exposure during pregnancy 24.86 18.01 75 24244 77600 64396813
Hypertension 24.79 18.01 175 24144 259086 64215327
Cardiac arrest 24.21 18.01 14 24305 154050 64320363
Sensory loss 23.86 18.01 24 24295 10145 64464268
Hypoglycaemia 23.64 18.01 3 24316 89889 64384524
Maternal exposure during pregnancy 23.37 18.01 4 24315 95880 64378533
Blood creatinine increased 23.31 18.01 11 24308 135771 64338642
Multiple organ dysfunction syndrome 23.09 18.01 5 24314 101408 64373005
Blood pressure increased 23.09 18.01 127 24192 172425 64301988
Expanded disability status scale score increased 22.59 18.01 8 24311 466 64473947
Treatment failure 22.43 18.01 8 24311 116808 64357605
Thrombocytopenia 22.40 18.01 31 24288 223770 64250643
Hypokalaemia 22.32 18.01 9 24310 121894 64352519
Temperature intolerance 22.21 18.01 21 24298 8234 64466179
Pleural effusion 22.12 18.01 10 24309 126549 64347864
Cardio-respiratory arrest 22.10 18.01 5 24314 98388 64376025
Rhabdomyolysis 21.98 18.01 4 24315 91722 64382691
General physical health deterioration 21.81 18.01 27 24292 204398 64270015
Therapeutic product effect incomplete 21.81 18.01 6 24313 103476 64370937
Neuralgia 21.77 18.01 37 24282 26147 64448266
Peroneal nerve palsy 21.34 18.01 17 24302 5304 64469109
Onychoclasis 21.31 18.01 16 24303 4576 64469837
Respiratory failure 20.91 18.01 18 24301 161165 64313248
Dysgraphia 20.49 18.01 14 24305 3457 64470956
Urinary tract infection 20.22 18.01 153 24166 231443 64242970
Testicular seminoma (pure) stage I 19.91 18.01 4 24315 23 64474390
Dizziness 19.66 18.01 248 24071 429915 64044498
Speech disorder 19.66 18.01 51 24268 48390 64426023
Cardiac failure 19.45 18.01 13 24306 132360 64342053
Gastrointestinal haemorrhage 19.43 18.01 13 24306 132299 64342114
Intentional product use issue 19.23 18.01 6 24313 95358 64379055
Septic shock 18.95 18.01 8 24311 105429 64368984
Wheelchair user 18.89 18.01 15 24304 4657 64469756
Dehydration 18.85 18.01 33 24286 216730 64257683
Depressed level of consciousness 18.57 18.01 4 24315 81432 64392981
Dyspnoea 18.35 18.01 178 24141 718496 63755917
Hemiparesis 18.32 18.01 37 24282 29790 64444623
Oedema peripheral 18.31 18.01 32 24287 210285 64264128
Pyrexia 18.03 18.01 130 24189 558514 63915899

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA31 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA MoA N0000185501 Dihydroorotate Dehydrogenase Inhibitors
FDA EPC N0000185502 Pyrimidine Synthesis Inhibitor
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:38637 tyrosine kinase inhibitors
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:68542 DHODH inhibitor

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Multiple sclerosis indication 24700007 DOID:2377




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.59 acidic
pKa2 10.61 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 6794410 Sept. 12, 2026 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 6794410 Sept. 12, 2026 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 9186346 Feb. 4, 2034 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 9186346 Feb. 4, 2034 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL April 30, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL April 30, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL Oct. 30, 2024 PEDIATRIC EXCLUSIVITY
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL Oct. 30, 2024 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme INHIBITOR Ki 7.52 CHEMBL CHEMBL
Dihydrofolate reductase Enzyme IC50 6.41 CHEMBL
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 8.05 CHEMBL
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 7.16 CHEMBL
Dihydroorotate dehydrogenase Enzyme Ki 4.66 CHEMBL
Dihydroorotate dehydrogenase Enzyme IC50 4.30 CHEMBL

External reference:

IDSource
D10172 KEGG_DRUG
4031717 VANDF
CHEBI:68540 CHEBI
A26 PDB_CHEM_ID
CHEMBL973 ChEMBL_ID
C527525 MESH_SUPPLEMENTAL_RECORD_UI
6844 IUPHAR_LIGAND_ID
7761 INN_ID
DB08880 DRUGBANK_ID
1C058IKG3B UNII
54684141 PUBCHEM_CID
1310520 RXNORM
193228 MMSL
28846 MMSL
d07905 MMSL
014643 NDDF
703785006 SNOMEDCT_US
703786007 SNOMEDCT_US
C1718383 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0115-1565 TABLET, FILM COATED 14 mg ORAL ANDA 20 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0210 TABLET, FILM COATED 14 mg ORAL NDA 32 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0210 TABLET, FILM COATED 14 mg ORAL NDA 32 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0211 TABLET, FILM COATED 7 mg ORAL NDA 32 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0211 TABLET, FILM COATED 7 mg ORAL NDA 32 sections
teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 68462-311 TABLET, FILM COATED 7 mg ORAL ANDA 29 sections
teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 68462-312 TABLET, FILM COATED 14 mg ORAL ANDA 29 sections
Teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 69238-1303 TABLET, FILM COATED 7 mg ORAL ANDA 23 sections
Teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 69238-1304 TABLET, FILM COATED 14 mg ORAL ANDA 23 sections
Teriflunomide Human Prescription Drug Label 1 69539-032 TABLET, FILM COATED 7 mg ORAL ANDA 27 sections
Teriflunomide Human Prescription Drug Label 1 69539-033 TABLET, FILM COATED 14 mg ORAL ANDA 27 sections