teriflunomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4634 | 163451-81-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 14 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
| S (Water solubility) | 0.03 mg/mL | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 26, 2013 | EMA | ||
| Sept. 12, 2012 | FDA | SANOFI AVENTIS US |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Multiple sclerosis relapse | 5537.79 | 17.13 | 1758 | 35990 | 46720 | 63404554 |
| Alopecia | 1673.49 | 17.13 | 1467 | 36281 | 336069 | 63115205 |
| Hypoaesthesia | 853.88 | 17.13 | 744 | 37004 | 167649 | 63283625 |
| Paraesthesia | 829.11 | 17.13 | 710 | 37038 | 156256 | 63295018 |
| Product dose omission issue | 604.78 | 17.13 | 719 | 37029 | 233594 | 63217680 |
| Balance disorder | 446.98 | 17.13 | 383 | 37365 | 84039 | 63367235 |
| Product dose omission in error | 369.45 | 17.13 | 147 | 37601 | 7465 | 63443809 |
| Fall | 349.85 | 17.13 | 739 | 37009 | 391595 | 63059679 |
| Diarrhoea | 328.54 | 17.13 | 1049 | 36699 | 714317 | 62736957 |
| Bladder disorder | 303.90 | 17.13 | 134 | 37614 | 8812 | 63442462 |
| Gait disturbance | 303.18 | 17.13 | 453 | 37295 | 182725 | 63268549 |
| Muscle spasticity | 235.47 | 17.13 | 152 | 37596 | 21642 | 63429632 |
| Fatigue | 227.20 | 17.13 | 1083 | 36665 | 886945 | 62564329 |
| Memory impairment | 220.13 | 17.13 | 290 | 37458 | 103968 | 63347306 |
| Off label use | 217.42 | 17.13 | 66 | 37682 | 674396 | 62776878 |
| Depression | 216.43 | 17.13 | 405 | 37343 | 196087 | 63255187 |
| Depressed mood | 203.65 | 17.13 | 178 | 37570 | 40013 | 63411261 |
| Visual impairment | 167.63 | 17.13 | 228 | 37520 | 84218 | 63367056 |
| Sensory disturbance | 164.26 | 17.13 | 102 | 37646 | 13570 | 63437704 |
| Mobility decreased | 139.83 | 17.13 | 255 | 37493 | 120904 | 63330370 |
| COVID-19 | 136.84 | 17.13 | 243 | 37505 | 112860 | 63338414 |
| Multiple sclerosis | 127.58 | 17.13 | 110 | 37638 | 24262 | 63427012 |
| Headache | 119.67 | 17.13 | 712 | 37036 | 632529 | 62818745 |
| Muscular weakness | 119.60 | 17.13 | 240 | 37508 | 122113 | 63329161 |
| Decreased interest | 114.57 | 17.13 | 50 | 37698 | 3204 | 63448070 |
| Optic neuritis | 114.35 | 17.13 | 68 | 37680 | 8367 | 63442907 |
| Toxicity to various agents | 113.12 | 17.13 | 9 | 37739 | 247241 | 63204033 |
| Unevaluable event | 113.10 | 17.13 | 146 | 37602 | 51240 | 63400034 |
| Contraindicated product administered | 111.71 | 17.13 | 4 | 37744 | 217644 | 63233630 |
| Limb discomfort | 107.12 | 17.13 | 109 | 37639 | 29607 | 63421667 |
| Acute kidney injury | 104.38 | 17.13 | 16 | 37732 | 263399 | 63187875 |
| Cognitive disorder | 103.65 | 17.13 | 146 | 37602 | 55669 | 63395605 |
| Rheumatoid arthritis | 101.53 | 17.13 | 15 | 37733 | 253804 | 63197470 |
| Synovitis | 93.99 | 17.13 | 4 | 37744 | 186914 | 63264360 |
| Glossodynia | 92.79 | 17.13 | 3 | 37745 | 178873 | 63272401 |
| Systemic lupus erythematosus | 86.72 | 17.13 | 11 | 37737 | 208907 | 63242367 |
| Maternal exposure during pregnancy | 85.73 | 17.13 | 14 | 37734 | 220048 | 63231226 |
| Therapeutic product effect decreased | 83.09 | 17.13 | 9 | 37739 | 193178 | 63258096 |
| Movement disorder | 82.74 | 17.13 | 82 | 37666 | 21579 | 63429695 |
| Burning sensation | 81.91 | 17.13 | 129 | 37619 | 54278 | 63396996 |
| Central nervous system lesion | 81.37 | 17.13 | 60 | 37688 | 10575 | 63440699 |
| Joint swelling | 77.09 | 17.13 | 50 | 37698 | 327616 | 63123658 |
| Urinary incontinence | 76.84 | 17.13 | 95 | 37653 | 31919 | 63419355 |
| JC polyomavirus test positive | 73.77 | 17.13 | 29 | 37719 | 1424 | 63449850 |
| Completed suicide | 73.62 | 17.13 | 3 | 37745 | 145670 | 63305604 |
| Condition aggravated | 69.81 | 17.13 | 443 | 37305 | 401774 | 63049500 |
| Throat clearing | 68.73 | 17.13 | 32 | 37716 | 2387 | 63448887 |
| Drug hypersensitivity | 65.78 | 17.13 | 53 | 37695 | 310634 | 63140640 |
| Pericarditis | 65.52 | 17.13 | 3 | 37745 | 131576 | 63319698 |
| Muscle spasms | 65.48 | 17.13 | 223 | 37525 | 155927 | 63295347 |
| Illness | 62.63 | 17.13 | 108 | 37640 | 48951 | 63402323 |
| Hypotension | 62.21 | 17.13 | 43 | 37705 | 272561 | 63178713 |
| Stress | 61.13 | 17.13 | 128 | 37620 | 67039 | 63384235 |
| Anaemia | 60.94 | 17.13 | 51 | 37697 | 293379 | 63157895 |
| Feeling abnormal | 60.53 | 17.13 | 210 | 37538 | 148182 | 63303092 |
| Wound | 58.03 | 17.13 | 13 | 37735 | 163250 | 63288024 |
| Arthropathy | 57.72 | 17.13 | 34 | 37714 | 234758 | 63216516 |
| Secondary progressive multiple sclerosis | 57.07 | 17.13 | 24 | 37724 | 1403 | 63449871 |
| Pneumonia | 55.53 | 17.13 | 118 | 37630 | 456649 | 62994625 |
| Intentional product use issue | 54.87 | 17.13 | 6 | 37742 | 127886 | 63323388 |
| Magnetic resonance imaging abnormal | 52.90 | 17.13 | 29 | 37719 | 3056 | 63448218 |
| Hyponatraemia | 51.34 | 17.13 | 4 | 37744 | 111896 | 63339378 |
| Death | 51.33 | 17.13 | 90 | 37658 | 374291 | 63076983 |
| Walking aid user | 51.32 | 17.13 | 46 | 37702 | 10671 | 63440603 |
| Spinal operation | 50.89 | 17.13 | 41 | 37707 | 8230 | 63443044 |
| Therapeutic product effect incomplete | 50.87 | 17.13 | 7 | 37741 | 125049 | 63326225 |
| Overdose | 50.39 | 17.13 | 5 | 37743 | 115073 | 63336201 |
| Injection site pain | 48.90 | 17.13 | 9 | 37739 | 129791 | 63321483 |
| Lower respiratory tract infection | 48.10 | 17.13 | 10 | 37738 | 132297 | 63318977 |
| Incontinence | 48.10 | 17.13 | 46 | 37702 | 11586 | 63439688 |
| Swelling | 47.80 | 17.13 | 56 | 37692 | 275322 | 63175952 |
| Micturition urgency | 47.51 | 17.13 | 42 | 37706 | 9569 | 63441705 |
| Pain in extremity | 45.54 | 17.13 | 345 | 37403 | 331141 | 63120133 |
| Electric shock sensation | 44.53 | 17.13 | 17 | 37731 | 771 | 63450503 |
| Drug interaction | 43.76 | 17.13 | 43 | 37705 | 229088 | 63222186 |
| Dyspnoea | 43.54 | 17.13 | 224 | 37524 | 661089 | 62790185 |
| Peroneal nerve palsy | 43.24 | 17.13 | 30 | 37718 | 4805 | 63446469 |
| Onychoclasis | 42.93 | 17.13 | 33 | 37715 | 6189 | 63445085 |
| Vision blurred | 41.81 | 17.13 | 135 | 37613 | 91789 | 63359485 |
| Helicobacter infection | 40.71 | 17.13 | 4 | 37744 | 92781 | 63358493 |
| Tremor | 39.06 | 17.13 | 169 | 37579 | 132070 | 63319204 |
| Drug intolerance | 38.93 | 17.13 | 78 | 37670 | 308583 | 63142691 |
| Treatment failure | 38.41 | 17.13 | 37 | 37711 | 199006 | 63252268 |
| Surgery | 36.90 | 17.13 | 72 | 37676 | 35840 | 63415434 |
| Band sensation | 35.98 | 17.13 | 15 | 37733 | 858 | 63450416 |
| Pancytopenia | 35.91 | 17.13 | 7 | 37741 | 96926 | 63354348 |
| Oedema peripheral | 35.68 | 17.13 | 36 | 37712 | 189475 | 63261799 |
| Lymphopenia | 35.58 | 17.13 | 49 | 37699 | 18278 | 63432996 |
| Haemoglobin decreased | 34.44 | 17.13 | 22 | 37726 | 145463 | 63305811 |
| Sexual dysfunction | 34.26 | 17.13 | 25 | 37723 | 4334 | 63446940 |
| General physical health deterioration | 33.82 | 17.13 | 42 | 37706 | 201360 | 63249914 |
| Pyrexia | 33.42 | 17.13 | 155 | 37593 | 470323 | 62980951 |
| Weight increased | 32.79 | 17.13 | 66 | 37682 | 260726 | 63190548 |
| Paraparesis | 32.77 | 17.13 | 19 | 37729 | 2229 | 63449045 |
| Respiratory failure | 32.58 | 17.13 | 10 | 37738 | 101848 | 63349426 |
| Neutropenia | 32.09 | 17.13 | 34 | 37714 | 174971 | 63276303 |
| Pleural effusion | 31.97 | 17.13 | 8 | 37740 | 93202 | 63358072 |
| Musculoskeletal stiffness | 31.70 | 17.13 | 203 | 37545 | 184415 | 63266859 |
| Temperature intolerance | 30.70 | 17.13 | 32 | 37716 | 8932 | 63442342 |
| Expanded disability status scale score increased | 30.62 | 17.13 | 12 | 37736 | 584 | 63450690 |
| Oedema | 30.49 | 17.13 | 10 | 37738 | 97612 | 63353662 |
| Thrombocytopenia | 30.46 | 17.13 | 27 | 37721 | 151130 | 63300144 |
| Discomfort | 30.15 | 17.13 | 33 | 37715 | 167341 | 63283933 |
| Speech disorder | 29.73 | 17.13 | 71 | 37677 | 40558 | 63410716 |
| Trigeminal neuralgia | 29.53 | 17.13 | 21 | 37727 | 3498 | 63447776 |
| Psoriatic arthropathy | 29.25 | 17.13 | 9 | 37739 | 91511 | 63359763 |
| Therapy non-responder | 29.15 | 17.13 | 5 | 37743 | 75896 | 63375378 |
| Stomatitis | 28.90 | 17.13 | 24 | 37724 | 138701 | 63312573 |
| Neuropathy peripheral | 28.89 | 17.13 | 139 | 37609 | 113528 | 63337746 |
| Dysstasia | 28.86 | 17.13 | 48 | 37700 | 21118 | 63430156 |
| Progressive multiple sclerosis | 28.64 | 17.13 | 14 | 37734 | 1164 | 63450110 |
| Breast cancer | 28.60 | 17.13 | 78 | 37670 | 48305 | 63402969 |
| Intentional overdose | 28.22 | 17.13 | 5 | 37743 | 74147 | 63377127 |
| Hair texture abnormal | 28.17 | 17.13 | 22 | 37726 | 4221 | 63447053 |
| Neuralgia | 27.89 | 17.13 | 53 | 37695 | 25873 | 63425401 |
| Osteoarthritis | 27.68 | 17.13 | 11 | 37737 | 95332 | 63355942 |
| Hypertension | 27.44 | 17.13 | 270 | 37478 | 279033 | 63172241 |
| Fibromyalgia | 27.39 | 17.13 | 7 | 37741 | 80413 | 63370861 |
| Dizziness | 27.30 | 17.13 | 382 | 37366 | 429543 | 63021731 |
| Cardiac arrest | 26.34 | 17.13 | 11 | 37737 | 92534 | 63358740 |
| Arthralgia | 25.75 | 17.13 | 216 | 37532 | 569494 | 62881780 |
| Impaired driving ability | 24.90 | 17.13 | 21 | 37727 | 4490 | 63446784 |
| Cerebral disorder | 24.84 | 17.13 | 21 | 37727 | 4505 | 63446769 |
| SARS-CoV-2 test positive | 24.49 | 17.13 | 27 | 37721 | 8029 | 63443245 |
| Anal incontinence | 24.43 | 17.13 | 35 | 37713 | 13541 | 63437733 |
| Asthenia | 24.40 | 17.13 | 341 | 37407 | 383263 | 63068011 |
| Hypokalaemia | 24.15 | 17.13 | 16 | 37732 | 103788 | 63347486 |
| Dysgraphia | 24.13 | 17.13 | 18 | 37730 | 3228 | 63448046 |
| Wheezing | 23.25 | 17.13 | 14 | 37734 | 95581 | 63355693 |
| Confusional state | 23.24 | 17.13 | 68 | 37680 | 236312 | 63214962 |
| Cardiac failure congestive | 23.24 | 17.13 | 13 | 37735 | 92420 | 63358854 |
| Hypoglycaemia | 22.97 | 17.13 | 4 | 37744 | 60061 | 63391213 |
| Blood creatinine increased | 22.60 | 17.13 | 12 | 37736 | 87832 | 63363442 |
| Gastrointestinal haemorrhage | 22.54 | 17.13 | 10 | 37738 | 81166 | 63370108 |
| Disease progression | 22.33 | 17.13 | 24 | 37724 | 122734 | 63328540 |
| Product use issue | 22 | 17.13 | 63 | 37685 | 220457 | 63230817 |
| Platelet count decreased | 21.91 | 17.13 | 22 | 37726 | 116100 | 63335174 |
| Hemiparesis | 21.91 | 17.13 | 45 | 37703 | 23237 | 63428037 |
| Blood pressure increased | 21.82 | 17.13 | 168 | 37580 | 161894 | 63289380 |
| Heteroplasia | 21.67 | 17.13 | 4 | 37744 | 7 | 63451267 |
| Oxygen saturation decreased | 21.50 | 17.13 | 13 | 37735 | 88572 | 63362702 |
| C-reactive protein increased | 21.49 | 17.13 | 15 | 37733 | 94692 | 63356582 |
| Drug effect less than expected | 21.30 | 17.13 | 13 | 37735 | 1676 | 63449598 |
| Type 2 diabetes mellitus | 20.92 | 17.13 | 6 | 37742 | 63862 | 63387412 |
| Cardio-respiratory arrest | 20.84 | 17.13 | 5 | 37743 | 59954 | 63391320 |
| Hypoxia | 20.76 | 17.13 | 5 | 37743 | 59787 | 63391487 |
| Renal failure | 20.31 | 17.13 | 24 | 37724 | 117628 | 63333646 |
| Needle fatigue | 20.28 | 17.13 | 6 | 37742 | 122 | 63451152 |
| Disturbance in attention | 20.06 | 17.13 | 59 | 37689 | 38130 | 63413144 |
| Hyperkalaemia | 19.89 | 17.13 | 4 | 37744 | 54199 | 63397075 |
| Pollakiuria | 19.56 | 17.13 | 48 | 37700 | 27889 | 63423385 |
| Deep vein thrombosis | 19.38 | 17.13 | 13 | 37735 | 83787 | 63367487 |
| Trichorrhexis | 19.07 | 17.13 | 11 | 37737 | 1278 | 63449996 |
| Vertigo | 18.80 | 17.13 | 78 | 37670 | 59809 | 63391465 |
| Hip arthroplasty | 18.60 | 17.13 | 3 | 37745 | 47643 | 63403631 |
| Anaphylactic reaction | 18.58 | 17.13 | 8 | 37740 | 66092 | 63385182 |
| Migraine | 18.56 | 17.13 | 115 | 37633 | 103231 | 63348043 |
| Infection | 18.39 | 17.13 | 72 | 37676 | 229101 | 63222173 |
| Depressed level of consciousness | 18.28 | 17.13 | 7 | 37741 | 62071 | 63389203 |
| Myelitis | 18.21 | 17.13 | 11 | 37737 | 1392 | 63449882 |
| Delirium | 17.99 | 17.13 | 4 | 37744 | 50537 | 63400737 |
| Cardiac failure | 17.86 | 17.13 | 16 | 37732 | 89126 | 63362148 |
| Dehydration | 17.67 | 17.13 | 49 | 37699 | 173305 | 63277969 |
| Paternal exposure timing unspecified | 17.67 | 17.13 | 4 | 37744 | 26 | 63451248 |
| Injury | 17.43 | 17.13 | 11 | 37737 | 73236 | 63378038 |
| Multiple organ dysfunction syndrome | 17.39 | 17.13 | 6 | 37742 | 56746 | 63394528 |
| Musculoskeletal disorder | 17.23 | 17.13 | 38 | 37710 | 20606 | 63430668 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Multiple sclerosis relapse | 1646.93 | 27.03 | 410 | 7073 | 12723 | 34936725 |
| Alopecia | 275.12 | 27.03 | 124 | 7359 | 24231 | 34925217 |
| Hypoaesthesia | 202.96 | 27.03 | 139 | 7344 | 61305 | 34888143 |
| Product dose omission issue | 171.11 | 27.03 | 166 | 7317 | 119545 | 34829903 |
| Paraesthesia | 158.97 | 27.03 | 122 | 7361 | 64050 | 34885398 |
| Gait disturbance | 156.50 | 27.03 | 136 | 7347 | 85004 | 34864444 |
| Product dose omission in error | 119.50 | 27.03 | 36 | 7447 | 2238 | 34947210 |
| Balance disorder | 117.81 | 27.03 | 85 | 7398 | 40569 | 34908879 |
| Fatigue | 97.85 | 27.03 | 232 | 7251 | 370421 | 34579027 |
| Multiple sclerosis | 88.35 | 27.03 | 38 | 7445 | 6607 | 34942841 |
| Fall | 86.47 | 27.03 | 155 | 7328 | 202730 | 34746718 |
| Diarrhoea | 82.95 | 27.03 | 225 | 7258 | 389687 | 34559761 |
| Mobility decreased | 73.83 | 27.03 | 57 | 7426 | 30071 | 34919377 |
| Muscle spasticity | 66.41 | 27.03 | 30 | 7453 | 5858 | 34943590 |
| Visual impairment | 65.20 | 27.03 | 57 | 7426 | 35745 | 34913703 |
| Memory impairment | 61.48 | 27.03 | 60 | 7423 | 43258 | 34906190 |
| Headache | 53.03 | 27.03 | 126 | 7357 | 200509 | 34748939 |
| Depressed mood | 52.74 | 27.03 | 39 | 7444 | 19278 | 34930170 |
| Off label use | 50.17 | 27.03 | 14 | 7469 | 419510 | 34529938 |
| Muscular weakness | 49.37 | 27.03 | 69 | 7414 | 72828 | 34876620 |
| Drug ineffective | 46.85 | 27.03 | 207 | 7276 | 456544 | 34492904 |
| Decreased interest | 43.30 | 27.03 | 17 | 7466 | 2343 | 34947105 |
| Trigeminal neuralgia | 41.92 | 27.03 | 14 | 7469 | 1215 | 34948233 |
| Bladder disorder | 40.99 | 27.03 | 18 | 7465 | 3286 | 34946162 |
| Acute kidney injury | 40.71 | 27.03 | 8 | 7475 | 304980 | 34644468 |
| Walking aid user | 39.35 | 27.03 | 15 | 7468 | 1909 | 34947539 |
| Depression | 38.42 | 27.03 | 72 | 7411 | 97026 | 34852422 |
| Limb discomfort | 36.35 | 27.03 | 25 | 7458 | 11022 | 34938426 |
| Abdominal discomfort | 35.19 | 27.03 | 53 | 7430 | 59782 | 34889666 |
| Optic neuritis | 33.43 | 27.03 | 16 | 7467 | 3558 | 34945890 |
| Musculoskeletal stiffness | 32.79 | 27.03 | 45 | 7438 | 46635 | 34902813 |
| Band sensation | 32.34 | 27.03 | 7 | 7476 | 112 | 34949336 |
| Condition aggravated | 32.00 | 27.03 | 102 | 7381 | 192094 | 34757354 |
| Feeling abnormal | 31.62 | 27.03 | 52 | 7431 | 63183 | 34886265 |
| Expanded disability status scale score increased | 29.75 | 27.03 | 8 | 7475 | 329 | 34949119 |
| Illness | 29.68 | 27.03 | 24 | 7459 | 13505 | 34935943 |
| Central nervous system lesion | 29.59 | 27.03 | 18 | 7465 | 6445 | 34943003 |
| Pollakiuria | 29.29 | 27.03 | 28 | 7455 | 19646 | 34929802 |
| Hypotension | 29.16 | 27.03 | 6 | 7477 | 221643 | 34727805 |
| Unevaluable event | 28.48 | 27.03 | 35 | 7448 | 32555 | 34916893 |
| Hepatic enzyme increased | 27.94 | 27.03 | 38 | 7445 | 39042 | 34910406 |
| Toxicity to various agents | 27.24 | 27.03 | 5 | 7478 | 200357 | 34749091 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Multiple sclerosis relapse | 5307.99 | 17.61 | 1572 | 33499 | 44961 | 79664356 |
| Alopecia | 1739.22 | 17.61 | 1143 | 33928 | 230212 | 79479105 |
| Hypoaesthesia | 868.92 | 17.61 | 680 | 34391 | 178672 | 79530645 |
| Paraesthesia | 765.36 | 17.61 | 627 | 34444 | 175696 | 79533621 |
| Product dose omission issue | 509.11 | 17.61 | 584 | 34487 | 246953 | 79462364 |
| Gait disturbance | 403.60 | 17.61 | 476 | 34595 | 207030 | 79502287 |
| Balance disorder | 383.52 | 17.61 | 330 | 34741 | 98527 | 79610790 |
| Fall | 322.29 | 17.61 | 680 | 34391 | 486949 | 79222368 |
| Diarrhoea | 302.66 | 17.61 | 959 | 34112 | 879530 | 78829787 |
| Fatigue | 298.31 | 17.61 | 989 | 34082 | 928738 | 78780579 |
| Product dose omission in error | 289.18 | 17.61 | 114 | 34957 | 7674 | 79701643 |
| Memory impairment | 241.56 | 17.61 | 271 | 34800 | 111463 | 79597854 |
| Bladder disorder | 228.50 | 17.61 | 101 | 34970 | 9064 | 79700253 |
| Off label use | 208.71 | 17.61 | 70 | 35001 | 907145 | 78802172 |
| Muscle spasticity | 207.50 | 17.61 | 125 | 34946 | 21350 | 79687967 |
| Visual impairment | 200.01 | 17.61 | 224 | 34847 | 91907 | 79617410 |
| Headache | 176.26 | 17.61 | 658 | 34413 | 653114 | 79056203 |
| Depression | 169.66 | 17.61 | 325 | 34746 | 216465 | 79492852 |
| Depressed mood | 164.20 | 17.61 | 150 | 34921 | 48330 | 79660987 |
| Multiple sclerosis | 158.72 | 17.61 | 107 | 34964 | 22175 | 79687142 |
| Acute kidney injury | 157.93 | 17.61 | 21 | 35050 | 519383 | 79189934 |
| Toxicity to various agents | 152.70 | 17.61 | 8 | 35063 | 421532 | 79287785 |
| Mobility decreased | 151.37 | 17.61 | 225 | 34846 | 121950 | 79587367 |
| Unevaluable event | 141.37 | 17.61 | 147 | 34924 | 55438 | 79653879 |
| Sensory disturbance | 138.55 | 17.61 | 85 | 34986 | 14992 | 79694325 |
| Muscular weakness | 133.16 | 17.61 | 247 | 34824 | 160482 | 79548835 |
| Limb discomfort | 129.91 | 17.61 | 111 | 34960 | 32739 | 79676578 |
| Optic neuritis | 117.50 | 17.61 | 65 | 35006 | 9455 | 79699862 |
| Decreased interest | 116.14 | 17.61 | 48 | 35023 | 3649 | 79705668 |
| COVID-19 | 96.80 | 17.61 | 214 | 34857 | 157460 | 79551857 |
| Feeling abnormal | 92.07 | 17.61 | 211 | 34860 | 158988 | 79550329 |
| Hypotension | 89.33 | 17.61 | 41 | 35030 | 440276 | 79269041 |
| Throat clearing | 88.63 | 17.61 | 36 | 35035 | 2618 | 79706699 |
| Completed suicide | 87.87 | 17.61 | 5 | 35066 | 245762 | 79463555 |
| Burning sensation | 84.34 | 17.61 | 116 | 34955 | 58516 | 79650801 |
| Secondary progressive multiple sclerosis | 83.40 | 17.61 | 29 | 35042 | 1368 | 79707949 |
| Pain in extremity | 83.32 | 17.61 | 349 | 34722 | 364189 | 79345128 |
| Central nervous system lesion | 82.98 | 17.61 | 59 | 35012 | 13309 | 79696008 |
| Cognitive disorder | 79.77 | 17.61 | 124 | 34947 | 69802 | 79639515 |
| Urinary incontinence | 79.49 | 17.61 | 94 | 34977 | 40815 | 79668502 |
| Muscle spasms | 76.21 | 17.61 | 208 | 34863 | 174522 | 79534795 |
| Anaemia | 75.09 | 17.61 | 52 | 35019 | 444963 | 79264354 |
| Walking aid user | 68.14 | 17.61 | 47 | 35024 | 10101 | 79699216 |
| Movement disorder | 67.33 | 17.61 | 71 | 35000 | 27188 | 79682129 |
| Drug interaction | 64.28 | 17.61 | 53 | 35018 | 415130 | 79294187 |
| Magnetic resonance imaging abnormal | 63.98 | 17.61 | 31 | 35040 | 3428 | 79705889 |
| Condition aggravated | 63.55 | 17.61 | 407 | 34664 | 500717 | 79208600 |
| Stress | 62.93 | 17.61 | 120 | 34951 | 79492 | 79629825 |
| Hyponatraemia | 62.40 | 17.61 | 4 | 35067 | 177844 | 79531473 |
| JC polyomavirus test positive | 61.39 | 17.61 | 24 | 35047 | 1578 | 79707739 |
| Trigeminal neuralgia | 59.78 | 17.61 | 30 | 35041 | 3579 | 79705738 |
| Pneumonia | 57.90 | 17.61 | 128 | 34943 | 660118 | 79049199 |
| Band sensation | 57.43 | 17.61 | 19 | 35052 | 769 | 79708548 |
| Neutropenia | 56.44 | 17.61 | 28 | 35043 | 287682 | 79421635 |
| Pancytopenia | 54.56 | 17.61 | 5 | 35066 | 165740 | 79543577 |
| Contraindicated product administered | 53.94 | 17.61 | 4 | 35067 | 157534 | 79551783 |
| Pain | 52.78 | 17.61 | 506 | 34565 | 703296 | 79006021 |
| Synovitis | 51.12 | 17.61 | 4 | 35067 | 150730 | 79558587 |
| Illness | 49.61 | 17.61 | 80 | 34991 | 46431 | 79662886 |
| Death | 49.49 | 17.61 | 110 | 34961 | 566404 | 79142913 |
| Drug hypersensitivity | 48.96 | 17.61 | 36 | 35035 | 298880 | 79410437 |
| Micturition urgency | 48.51 | 17.61 | 42 | 35029 | 12599 | 79696718 |
| Overdose | 48.12 | 17.61 | 11 | 35060 | 184195 | 79525122 |
| Electric shock sensation | 48.10 | 17.61 | 17 | 35054 | 842 | 79708475 |
| Spinal operation | 46.97 | 17.61 | 34 | 35037 | 7883 | 79701434 |
| Disease progression | 46.22 | 17.61 | 12 | 35059 | 184350 | 79524967 |
| Rheumatoid arthritis | 46.12 | 17.61 | 17 | 35054 | 208453 | 79500864 |
| Surgery | 45.87 | 17.61 | 64 | 35007 | 32702 | 79676615 |
| Bradycardia | 44.86 | 17.61 | 4 | 35067 | 135553 | 79573764 |
| Therapeutic product effect decreased | 44.40 | 17.61 | 9 | 35062 | 163854 | 79545463 |
| Musculoskeletal stiffness | 44.21 | 17.61 | 173 | 34898 | 174835 | 79534482 |
| Peroneal nerve palsy | 42.98 | 17.61 | 29 | 35042 | 6013 | 79703304 |
| Haemoglobin decreased | 42.97 | 17.61 | 22 | 35049 | 222097 | 79487220 |
| Therapeutic product effect incomplete | 42.30 | 17.61 | 6 | 35065 | 141639 | 79567678 |
| Intentional product use issue | 41.96 | 17.61 | 8 | 35063 | 152104 | 79557213 |
| Treatment failure | 41.05 | 17.61 | 12 | 35059 | 170474 | 79538843 |
| Expanded disability status scale score increased | 40.54 | 17.61 | 14 | 35057 | 647 | 79708670 |
| Maternal exposure during pregnancy | 40.27 | 17.61 | 6 | 35065 | 136532 | 79572785 |
| Vision blurred | 40.23 | 17.61 | 120 | 34951 | 105778 | 79603539 |
| Injection site pain | 39.96 | 17.61 | 5 | 35066 | 129833 | 79579484 |
| Thrombocytopenia | 39.62 | 17.61 | 35 | 35036 | 265224 | 79444093 |
| Hyperkalaemia | 38.88 | 17.61 | 3 | 35068 | 114395 | 79594922 |
| Impaired driving ability | 38.54 | 17.61 | 26 | 35045 | 5389 | 79703928 |
| Dyspnoea | 38.28 | 17.61 | 221 | 34850 | 856804 | 78852513 |
| Pollakiuria | 38.19 | 17.61 | 63 | 35008 | 37254 | 79672063 |
| Migraine | 37.95 | 17.61 | 104 | 34967 | 87389 | 79621928 |
| Pyrexia | 37.75 | 17.61 | 162 | 34909 | 678547 | 79030770 |
| Platelet count decreased | 36.59 | 17.61 | 20 | 35051 | 194644 | 79514673 |
| Sexual dysfunction | 36.47 | 17.61 | 29 | 35042 | 7734 | 79701583 |
| Renal impairment | 36.38 | 17.61 | 12 | 35059 | 157771 | 79551546 |
| Paraparesis | 36.37 | 17.61 | 22 | 35049 | 3781 | 79705536 |
| Abdominal discomfort | 36.34 | 17.61 | 211 | 34860 | 250516 | 79458801 |
| Breast cancer | 35.88 | 17.61 | 58 | 35013 | 33723 | 79675594 |
| Progressive multiple sclerosis | 35.54 | 17.61 | 15 | 35056 | 1202 | 79708115 |
| Pleural effusion | 35.38 | 17.61 | 10 | 35061 | 145252 | 79564065 |
| Tremor | 35.05 | 17.61 | 158 | 34913 | 169925 | 79539392 |
| Pericarditis | 34.69 | 17.61 | 3 | 35068 | 104233 | 79605084 |
| General physical health deterioration | 34.68 | 17.61 | 42 | 35029 | 275196 | 79434121 |
| Hand deformity | 34.56 | 17.61 | 3 | 35068 | 103916 | 79605401 |
| Glossodynia | 34.32 | 17.61 | 3 | 35068 | 103334 | 79605983 |
| Dysstasia | 34.16 | 17.61 | 51 | 35020 | 27695 | 79681622 |
| Multiple organ dysfunction syndrome | 33.86 | 17.61 | 6 | 35065 | 120240 | 79589077 |
| Blood creatinine increased | 33.69 | 17.61 | 13 | 35058 | 155044 | 79554273 |
| Hypoglycaemia | 33.60 | 17.61 | 3 | 35068 | 101591 | 79607726 |
| Incontinence | 33.40 | 17.61 | 36 | 35035 | 14128 | 79695189 |
| Lymphopenia | 33.19 | 17.61 | 53 | 35018 | 30504 | 79678813 |
| Hair texture abnormal | 32.65 | 17.61 | 20 | 35051 | 3514 | 79705803 |
| Cardiac failure congestive | 32.53 | 17.61 | 11 | 35060 | 142391 | 79566926 |
| Speech disorder | 32.35 | 17.61 | 73 | 34998 | 54372 | 79654945 |
| Respiratory failure | 32.00 | 17.61 | 20 | 35051 | 180891 | 79528426 |
| Cardiac arrest | 31.88 | 17.61 | 18 | 35053 | 172078 | 79537239 |
| Rhabdomyolysis | 31.67 | 17.61 | 4 | 35067 | 103127 | 79606190 |
| Cardio-respiratory arrest | 31.47 | 17.61 | 5 | 35066 | 108505 | 79600812 |
| Lower respiratory tract infection | 31.28 | 17.61 | 9 | 35062 | 129211 | 79580106 |
| Oedema peripheral | 31.25 | 17.61 | 39 | 35032 | 252249 | 79457068 |
| Asthenia | 31.19 | 17.61 | 353 | 34718 | 511336 | 79197981 |
| Onychoclasis | 30.94 | 17.61 | 23 | 35048 | 5555 | 79703762 |
| Temperature intolerance | 30.84 | 17.61 | 29 | 35042 | 9676 | 79699641 |
| Renal failure | 30.63 | 17.61 | 26 | 35045 | 200942 | 79508375 |
| Dysgraphia | 30.24 | 17.61 | 20 | 35051 | 4012 | 79705305 |
| Neuralgia | 29.74 | 17.61 | 53 | 35018 | 33331 | 79675986 |
| Gastrointestinal haemorrhage | 29.52 | 17.61 | 14 | 35057 | 147705 | 79561612 |
| Dehydration | 29.07 | 17.61 | 40 | 35031 | 248147 | 79461170 |
| Cardiac failure | 28.96 | 17.61 | 16 | 35055 | 154826 | 79554491 |
| Dizziness | 28.48 | 17.61 | 355 | 34716 | 526086 | 79183231 |
| Systemic lupus erythematosus | 28.30 | 17.61 | 9 | 35062 | 121140 | 79588177 |
| Heteroplasia | 28.16 | 17.61 | 5 | 35066 | 10 | 79709307 |
| Pulmonary oedema | 28.15 | 17.61 | 3 | 35068 | 88251 | 79621066 |
| Hemiparesis | 28.08 | 17.61 | 52 | 35019 | 33681 | 79675636 |
| Joint swelling | 27.73 | 17.61 | 53 | 35018 | 288593 | 79420724 |
| Hypoxia | 27.28 | 17.61 | 6 | 35065 | 103237 | 79606080 |
| Septic shock | 27.17 | 17.61 | 10 | 35061 | 122791 | 79586526 |
| Sensory loss | 27.15 | 17.61 | 31 | 35040 | 12960 | 79696357 |
| Back pain | 26.93 | 17.61 | 227 | 34844 | 303953 | 79405364 |
| Hypokalaemia | 26.77 | 17.61 | 15 | 35056 | 144025 | 79565292 |
| Delirium | 26.68 | 17.61 | 3 | 35068 | 84624 | 79624693 |
| Wheezing | 26.67 | 17.61 | 9 | 35062 | 116655 | 79592662 |
| Intentional overdose | 26.35 | 17.61 | 7 | 35064 | 105953 | 79603364 |
| Urinary tract infection | 25.99 | 17.61 | 208 | 34863 | 274304 | 79435013 |
| Interstitial lung disease | 25.20 | 17.61 | 9 | 35062 | 112591 | 79596726 |
| Wheelchair user | 24.80 | 17.61 | 21 | 35050 | 6111 | 79703206 |
| Blood pressure increased | 24.47 | 17.61 | 168 | 34903 | 211192 | 79498125 |
| Oedema | 24.40 | 17.61 | 11 | 35060 | 119569 | 79589748 |
| Electrocardiogram QT prolonged | 24.40 | 17.61 | 5 | 35066 | 90381 | 79618936 |
| Hypertension | 24.21 | 17.61 | 237 | 34834 | 330755 | 79378562 |
| Drug intolerance | 24.07 | 17.61 | 50 | 35021 | 264069 | 79445248 |
| Trichorrhexis | 23.55 | 17.61 | 10 | 35061 | 813 | 79708504 |
| Nausea | 23.43 | 17.61 | 568 | 34503 | 956628 | 78752689 |
| Influenza like illness | 23.30 | 17.61 | 77 | 34994 | 71630 | 79637687 |
| Oxygen saturation decreased | 23.19 | 17.61 | 14 | 35057 | 129033 | 79580284 |
| Ascites | 23.03 | 17.61 | 3 | 35068 | 75559 | 79633758 |
| Hepatic enzyme increased | 22.85 | 17.61 | 148 | 34923 | 182462 | 79526855 |
| Anaphylactic reaction | 21.86 | 17.61 | 5 | 35066 | 83738 | 79625579 |
| Depressed level of consciousness | 21.16 | 17.61 | 8 | 35063 | 96644 | 79612673 |
| Stomatitis | 21.14 | 17.61 | 20 | 35051 | 146737 | 79562580 |
| Bladder discomfort | 21.02 | 17.61 | 9 | 35062 | 747 | 79708570 |
| Confusional state | 20.79 | 17.61 | 71 | 35000 | 317926 | 79391391 |
| Gait inability | 20.71 | 17.61 | 65 | 35006 | 58852 | 79650465 |
| Hallucination | 20.70 | 17.61 | 6 | 35065 | 85739 | 79623578 |
| Helicobacter infection | 20.69 | 17.61 | 3 | 35068 | 69701 | 79639616 |
| Deep vein thrombosis | 20.52 | 17.61 | 14 | 35057 | 120905 | 79588412 |
| Cerebral disorder | 20.44 | 17.61 | 18 | 35053 | 5520 | 79703797 |
| Syncope | 19.94 | 17.61 | 30 | 35041 | 179419 | 79529898 |
| Lipase increased | 19.89 | 17.61 | 30 | 35041 | 16436 | 79692881 |
| Weight decreased | 19.81 | 17.61 | 241 | 34830 | 354957 | 79354360 |
| Testicular seminoma (pure) stage I | 19.29 | 17.61 | 4 | 35067 | 23 | 79709294 |
| Intervertebral disc protrusion | 19.14 | 17.61 | 36 | 35035 | 23585 | 79685732 |
| Heavy menstrual bleeding | 19.06 | 17.61 | 27 | 35044 | 13984 | 79695333 |
| Sepsis | 18.40 | 17.61 | 59 | 35012 | 269369 | 79439948 |
| Intentional dose omission | 18.36 | 17.61 | 21 | 35050 | 8796 | 79700521 |
| Hospitalisation | 18.25 | 17.61 | 86 | 34985 | 94150 | 79615167 |
| Vertigo | 18.00 | 17.61 | 69 | 35002 | 69013 | 79640304 |
| Osteoarthritis | 17.86 | 17.61 | 8 | 35063 | 87301 | 79622016 |
| Wound | 17.73 | 17.61 | 15 | 35056 | 116164 | 79593153 |
| Meningoencephalitis herpetic | 17.73 | 17.61 | 11 | 35060 | 1978 | 79707339 |
| Anal incontinence | 17.69 | 17.61 | 30 | 35041 | 18138 | 79691179 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Multiple sclerosis | indication | 24700007 | DOID:2377 |
| Relapsing remitting multiple sclerosis | indication | 426373005 | DOID:2378 |
| Severe hypoproteinaemia | contraindication | 8900005 | |
| Nephrotic syndrome | contraindication | 52254009 | DOID:1184 |
| Significant leucopenia | contraindication | 84828003 | DOID:615 |
| Severe renal impairment undergoing dialysis | contraindication | 105502003 | |
| Severe immunodeficiency state | contraindication | 234532001 | DOID:612 |
| Significant anaemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Significant thrombocytopenia | contraindication | 302215000 | DOID:1588 |
| Significant neutropenia | contraindication | 303011007 | DOID:1227 |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Severe hepatic impairment | contraindication | 710067001 | |
| Severe active infection | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 5.59 | acidic |
| pKa2 | 10.61 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 14MG | TERIFLUNOMIDE | WATSON LABS TEVA | A209549 | July 27, 2018 | DISCN | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | WATSON LABS TEVA | A209549 | July 27, 2018 | DISCN | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | APOTEX | A209601 | Nov. 2, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | APOTEX | A209601 | Nov. 2, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | AMNEAL PHARMS CO | A209613 | Sept. 28, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | AMNEAL PHARMS CO | A209613 | Sept. 28, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | AUROBINDO PHARMA | A209638 | Oct. 26, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | AUROBINDO PHARMA | A209638 | Oct. 26, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | GLENMARK PHARMS | A209663 | Nov. 15, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | GLENMARK PHARMS | A209663 | Nov. 15, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | ZYDUS PHARMS | A209668 | Nov. 30, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | ZYDUS PHARMS | A209668 | Nov. 30, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | ACCORD HLTHCARE | A209690 | Jan. 7, 2019 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | ACCORD HLTHCARE | A209690 | Jan. 7, 2019 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | TEVA PHARMS USA | A209700 | Sept. 4, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | TEVA PHARMS USA | A209700 | Sept. 4, 2018 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 14MG | TERIFLUNOMIDE | SANDOZ | A209710 | Jan. 3, 2019 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 7MG | TERIFLUNOMIDE | SANDOZ | A209710 | Jan. 3, 2019 | RX | TABLET | ORAL | Sept. 8, 2023 | PATENT CHALLENGE |
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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 |
| 1310520 | RXNORM |
| 193228 | MMSL |
| 28846 | MMSL |
| 365635 | MMSL |
| d07905 | MMSL |
| 014643 | NDDF |
| 703785006 | SNOMEDCT_US |
| 703786007 | SNOMEDCT_US |
| C1718383 | UMLSCUI |
| 54684141 | PUBCHEM_CID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1565 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 20 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0627 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 31 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0628 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 31 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-3156 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-3157 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5747 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5755 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-399 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 30 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-400 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 30 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-246 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-247 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-830 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-831 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-281 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 26 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-282 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 26 sections |
| TERIFLUNOMIDE | Human Prescription Drug Label | 1 | 46708-313 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| TERIFLUNOMIDE | Human Prescription Drug Label | 1 | 46708-314 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51991-881 | TABLET | 7 mg | ORAL | ANDA | 33 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51991-882 | TABLET | 14 mg | ORAL | ANDA | 33 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 | 58468-0210 | 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 |
| Aubagio | HUMAN PRESCRIPTION DRUG LABEL | 1 | 58468-0211 | TABLET, FILM COATED | 7 mg | ORAL | NDA | 32 sections |
| Teriflunomide | Human Prescription Drug Label | 1 | 59651-054 | TABLET | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | Human Prescription Drug Label | 1 | 59651-055 | TABLET | 14 mg | ORAL | ANDA | 28 sections |
| teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4477 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4478 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 sections |
| TERIFLUNOMIDE | Human Prescription Drug Label | 1 | 62332-313 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |