sofosbuvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antivirals RNA polymerase (NS5B) inhibitors 4811 1190307-88-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sofosbuvir
  • sovaldi
  • PSI-7977
A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.
  • Molecular weight: 529.46
  • Formula: C22H29FN3O9P
  • CLOGP: 0.84
  • LIPINSKI: 2
  • HAC: 12
  • HDO: 3
  • TPSA: 152.73
  • ALOGS: -2.81
  • ROTB: 11
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 2 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 9.10 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K21,MAP3K7,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 34
kinase-selectivity-class AXL,CDK9,GRK2,MAP2K6,TEK,ZAP70 6
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Dec. 6, 2013 FDA GILEAD SCIENCES INC
March 26, 2015 PMDA Gilead Sciences K.K.
Jan. 16, 2014 EMA GILEAD SCIENCES IRELAND UC

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
Hepatocellular carcinoma 807.95 23.03 153 10635 2275 90615384
Hepatitis C 772.23 23.03 170 10618 5490 90612169
Anaemia 349.00 23.03 307 10481 352495 90265164
Hepatic encephalopathy 217.47 23.03 76 10712 13696 90603963
Ascites 178.62 23.03 95 10693 47645 90570014
Fatigue 178.10 23.03 409 10379 1153614 89464045
Hepatitis B reactivation 160.55 23.03 45 10743 3929 90613730
Genotype drug resistance test positive 153.69 23.03 29 10759 420 90617239
Hyperbilirubinaemia 142.87 23.03 56 10732 13880 90603779
Hepatic failure 134.48 23.03 74 10714 39654 90578005
Hepatic cirrhosis 121.60 23.03 82 10706 63171 90554488
Viral load increased 112.74 23.03 28 10760 1528 90616131
Haemoglobin decreased 108.30 23.03 114 10674 161842 90455817
Headache 100.97 23.03 276 10512 862470 89755189
Oesophageal varices haemorrhage 98.88 23.03 25 10763 1467 90616192
Blood bilirubin increased 94.82 23.03 61 10727 43409 90574250
Viral mutation identified 91.31 23.03 25 10763 2000 90615659
Hepatitis C RNA positive 89.60 23.03 14 10774 58 90617601
Jaundice 81.90 23.03 50 10738 32467 90585192
Photosensitivity reaction 73.86 23.03 38 10750 17769 90599890
Nausea 73.65 23.03 293 10495 1110023 89507636
Cryoglobulinaemia 71.04 23.03 17 10771 793 90616866
Liver transplant 70.28 23.03 21 10767 2296 90615363
Insomnia 69.14 23.03 134 10654 333340 90284319
Virologic failure 66.78 23.03 20 10768 2204 90615455
Drug ineffective 63.84 23.03 328 10460 1383970 89233689
Drug interaction 62.11 23.03 115 10673 276338 90341321
Influenza like illness 61.54 23.03 61 10727 80550 90537109
Hepatitis C RNA increased 59.39 23.03 11 10777 143 90617516
Portal vein thrombosis 56.04 23.03 19 10769 3119 90614540
Hepatic cancer recurrent 51.21 23.03 10 10778 175 90617484
Renal impairment 49.71 23.03 62 10726 105359 90512300
Treatment failure 47.64 23.03 109 10679 303819 90313840
Sunburn 47.62 23.03 17 10771 3250 90614409
Exposure via partner 42.06 23.03 8 10780 121 90617538
Drug resistance 39.19 23.03 31 10757 30418 90587241
Exposure via body fluid 39.10 23.03 10 10778 614 90617045
Drug intolerance 39.04 23.03 4 10784 447587 90170072
Hepatorenal syndrome 38.95 23.03 13 10775 2035 90615624
Drug hypersensitivity 38.30 23.03 5 10783 463604 90154055
Hepatic cancer 37.64 23.03 16 10772 4865 90612794
Hepatitis C virus test positive 36.32 23.03 7 10781 114 90617545
Varices oesophageal 34.59 23.03 14 10774 3765 90613894
Asthenia 32.84 23.03 138 10650 533613 90084046
Chills 32.25 23.03 57 10731 131924 90485735
Joint swelling 32.12 23.03 10 10778 503290 90114369
Remission not achieved 31.87 23.03 7 10781 222 90617437
Off label use 30.77 23.03 230 10558 1102022 89515637
Arthropathy 30.11 23.03 4 10784 366238 90251421
Sinus node dysfunction 29.76 23.03 14 10774 5398 90612261
Irritability 29.09 23.03 28 10760 35634 90582025
Fibrosis 28.49 23.03 14 10774 5938 90611721
Blood bilirubin abnormal 27.80 23.03 10 10778 1954 90615705
Renal failure 27.50 23.03 53 10735 130954 90486705
Rheumatoid arthritis 27.45 23.03 5 10783 362609 90255050
Product use in unapproved indication 26.87 23.03 4 10784 336232 90281427
Acute kidney injury 26.41 23.03 91 10697 320296 90297363
Pain 25.63 23.03 50 10738 996291 89621368
Glomerulonephritis 25.57 23.03 10 10778 2460 90615199
Myalgia 25.42 23.03 61 10727 175064 90442595
Exposure via father 24.82 23.03 6 10782 292 90617367
Peritonitis bacterial 24.26 23.03 12 10776 5159 90612500
Hypersensitivity 24.13 23.03 12 10776 454665 90162994
Transcatheter arterial chemoembolisation 24.11 23.03 3 10785 0 90617659
Autoimmune hepatitis 23.73 23.03 15 10773 10336 90607323
Complications of transplanted lung 23.50 23.03 6 10782 366 90617293

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
Hepatitis C 2108.48 19.37 545 17475 9588 42593727
Hepatocellular carcinoma 2026.45 19.37 506 17514 7688 42595627
Treatment failure 836.40 19.37 443 17577 62181 42541134
Genotype drug resistance test positive 749.78 19.37 158 17862 1046 42602269
Drug ineffective 589.46 19.37 989 17031 629208 41974107
Hepatic encephalopathy 346.26 19.37 159 17861 16283 42587032
Hepatic cirrhosis 324.79 19.37 161 17859 19541 42583774
Liver transplant 282.99 19.37 85 17935 2606 42600709
Fatigue 240.76 19.37 551 17469 435090 42168225
Ascites 232.30 19.37 192 17828 56486 42546829
Headache 197.35 19.37 358 17662 239011 42364304
Hepatic failure 190.19 19.37 145 17875 37955 42565360
Hepatic cancer 181.55 19.37 83 17937 8397 42594918
Hyperbilirubinaemia 172.73 19.37 108 17912 20527 42582788
Hepatitis C RNA positive 162.70 19.37 32 17988 141 42603174
Insomnia 152.32 19.37 217 17803 118036 42485279
Viral mutation identified 144.40 19.37 54 17966 3277 42600038
Anaemia 142.54 19.37 344 17676 279934 42323381
Virologic failure 138.36 19.37 55 17965 3939 42599376
Hepatitis C RNA increased 128.11 19.37 29 17991 277 42603038
Oesophageal varices haemorrhage 119.15 19.37 48 17972 3559 42599756
Jaundice 118.82 19.37 106 17914 34483 42568832
Hepatic hydrothorax 111.83 19.37 19 18001 27 42603288
Hepatitis B reactivation 111.34 19.37 49 17971 4529 42598786
Hepatic cancer recurrent 110.55 19.37 26 17994 298 42603017
Blood bilirubin increased 99.05 19.37 105 17915 42147 42561168
Hepatorenal syndrome 90.90 19.37 37 17983 2817 42600498
Peritonitis bacterial 89.30 19.37 48 17972 6867 42596448
Irritability 66.07 19.37 70 17950 28058 42575257
Viral load increased 63.08 19.37 29 17991 2968 42600347
Influenza like illness 60.62 19.37 71 17949 31769 42571546
Therapeutic embolisation 60.61 19.37 16 18004 302 42603013
Portal vein thrombosis 59.92 19.37 32 17988 4517 42598798
Varices oesophageal 55.52 19.37 30 17990 4335 42598980
Bleeding varicose vein 53.61 19.37 15 18005 355 42602960
Hepatitis C virus test positive 51.09 19.37 14 18006 306 42603009
Haemoglobin decreased 50.12 19.37 146 17874 132325 42470990
Toxicity to various agents 48.76 19.37 18 18002 229118 42374197
Product quality issue 42.87 19.37 45 17975 17837 42585478
Febrile neutropenia 42.26 19.37 13 18007 185690 42417625
Genital herpes simplex 42.02 19.37 10 18010 121 42603194
Hypotension 41.73 19.37 29 17991 257602 42345713
Depression 40.44 19.37 121 17899 111242 42492073
Remission not achieved 39.85 19.37 10 18010 153 42603162
Complications of transplanted lung 36.96 19.37 11 18009 326 42602989
Photosensitivity reaction 36.00 19.37 35 17985 12667 42590648
Nausea 34.18 19.37 285 17735 396514 42206801
Biliary colic 33.37 19.37 14 18006 1150 42602165
Drug abuse 30.72 19.37 4 18016 104767 42498548
Thought blocking 30.66 19.37 8 18012 144 42603171
Portal hypertension 30.16 19.37 21 17999 4766 42598549
Encephalopathy 29.10 19.37 58 17962 41275 42562040
Drug hypersensitivity 28.65 19.37 4 18016 99385 42503930
Diabetic hyperglycaemic coma 28.54 19.37 6 18014 39 42603276
Genital herpes 28.16 19.37 11 18009 751 42602564
Incorrect product administration duration 26.31 19.37 21 17999 5859 42597456
Liver transplant rejection 25.78 19.37 15 18005 2498 42600817
Abdominal cavity drainage 25.77 19.37 9 18011 448 42602867
Malignant neoplasm progression 25.72 19.37 7 18013 108393 42494922
Hepatic neoplasm 24.95 19.37 14 18006 2177 42601138
Product use in unapproved indication 24.62 19.37 25 17995 184431 42418884
Liver disorder 23.67 19.37 52 17968 39592 42563723
Pulmonary embolism 22.83 19.37 11 18009 119601 42483714
Off label use 22.76 19.37 387 17633 637948 41965367
Coma hepatic 22.23 19.37 8 18012 435 42602880
Choroiditis 21.93 19.37 11 18009 1364 42601951
Porphyria non-acute 21.38 19.37 8 18012 486 42602829
Hydrocholecystis 21.14 19.37 8 18012 501 42602814
Cryoglobulinaemia 20.40 19.37 8 18012 552 42602763
Sunburn 20.06 19.37 12 18008 2103 42601212
Hyponatraemia 19.88 19.37 9 18011 101453 42501862
Inappropriate schedule of product administration 19.59 19.37 8 18012 95894 42507421

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
Hepatitis C 2658.76 18.11 610 25071 11963 110551655
Hepatocellular carcinoma 2488.40 18.11 553 25128 9327 110554291
Genotype drug resistance test positive 660.95 18.11 132 25549 1274 110562344
Hepatic encephalopathy 518.27 18.11 208 25473 28048 110535570
Ascites 448.04 18.11 275 25406 92533 110471085
Anaemia 444.16 18.11 588 25093 546498 110017120
Hepatic cirrhosis 395.90 18.11 227 25454 67399 110496219
Fatigue 390.20 18.11 863 24818 1215095 109348523
Drug ineffective 385.50 18.11 984 24697 1519556 109044062
Treatment failure 368.15 18.11 384 25297 276850 110286768
Hepatic failure 319.71 18.11 199 25482 68540 110495078
Liver transplant 319.38 18.11 92 25589 4497 110559121
Hyperbilirubinaemia 317.69 18.11 151 25530 30520 110533098
Viral mutation identified 248.01 18.11 75 25606 4344 110559274
Hepatic cancer 239.18 18.11 92 25589 11064 110552554
Oesophageal varices haemorrhage 235.52 18.11 74 25607 4871 110558747
Hepatitis C RNA positive 234.29 18.11 42 25639 210 110563408
Hepatitis B reactivation 224.38 18.11 79 25602 7405 110556213
Insomnia 222.87 18.11 341 25340 360249 110203369
Headache 218.62 18.11 568 25113 881809 109681809
Jaundice 191.95 18.11 137 25544 59099 110504519
Virologic failure 190.44 18.11 63 25618 4889 110558729
Hepatic cancer recurrent 160.72 18.11 32 25649 303 110563315
Blood bilirubin increased 159.68 18.11 136 25545 75836 110487782
Hepatitis C RNA increased 146.36 18.11 31 25650 408 110563210
Haemoglobin decreased 140.63 18.11 226 25455 248501 110315117
Hepatorenal syndrome 132.00 18.11 47 25634 4550 110559068
Hepatic hydrothorax 119.61 18.11 21 25660 91 110563527
Peritonitis bacterial 118.71 18.11 55 25626 10478 110553140
Viral load increased 114.03 18.11 39 25642 3351 110560267
Portal vein thrombosis 112.41 18.11 47 25634 7011 110556607
Irritability 99.23 18.11 85 25596 47724 110515894
Influenza like illness 93.65 18.11 109 25572 88303 110475315
Cryoglobulinaemia 90.58 18.11 26 25655 1253 110562365
Varices oesophageal 88.62 18.11 40 25641 7175 110556443
Drug hypersensitivity 79.65 18.11 7 25674 454083 110109535
Nausea 74.77 18.11 516 25165 1235174 109328444
Therapeutic embolisation 69.95 18.11 18 25663 572 110563046
Hepatitis C virus test positive 65.67 18.11 16 25665 405 110563213
Joint swelling 63.11 18.11 13 25668 442832 110120786
Complications of transplanted lung 62.29 18.11 17 25664 680 110562938
Renal impairment 62.14 18.11 136 25545 188309 110375309
Remission not achieved 62.10 18.11 16 25665 511 110563107
Drug interaction 55.85 18.11 247 25434 499936 110063682
Toxicity to various agents 52.42 18.11 23 25658 480532 110083086
Photosensitivity reaction 52.08 18.11 45 25636 25544 110538074
Haematemesis 51.42 18.11 66 25615 59042 110504576
Portal hypertension 50.49 18.11 29 25652 8608 110555010
Encephalopathy 48.96 18.11 76 25605 80979 110482639
Arthropathy 48.88 18.11 5 25676 287517 110276101
Depression 46.82 18.11 171 25510 317164 110246454
Drug intolerance 46.69 18.11 18 25663 406494 110157124
Hypersensitivity 46.21 18.11 18 25663 403980 110159638
Renal failure 45.90 18.11 136 25545 226438 110337180
Myalgia 45.55 18.11 134 25547 222247 110341371
Rheumatoid arthritis 44.35 18.11 8 25673 299605 110264013
Therapeutic product effect decreased 42.18 18.11 4 25677 244312 110319306
Wheezing 41.96 18.11 5 25676 255225 110308393
Amaurosis fugax 41.73 18.11 17 25664 2373 110561245
Asthenia 41.01 18.11 287 25394 688712 109874906
Asthma 40.91 18.11 5 25676 250286 110313332
Product use in unapproved indication 40.62 18.11 27 25654 447350 110116268
Nasopharyngitis 39.75 18.11 21 25660 394340 110169278
Hepatectomy 38.55 18.11 10 25671 328 110563290
Pain 38.53 18.11 105 25576 954850 109608768
Condition aggravated 38.47 18.11 70 25611 734766 109828852
Product dose omission issue 38.23 18.11 162 25519 321620 110241998
Sinusitis 37.78 18.11 11 25670 296677 110266941
Therapeutic product effect incomplete 37.76 18.11 4 25677 223801 110339817
Abdominal cavity drainage 36.67 18.11 12 25669 899 110562719
Sinus node dysfunction 36.57 18.11 24 25657 9023 110554595
Contraindicated product administered 35.94 18.11 7 25674 248260 110315358
Weight increased 35.89 18.11 27 25654 419617 110144001
Febrile neutropenia 34.78 18.11 15 25666 316752 110246866
Impaired healing 34.55 18.11 3 25678 196714 110366904
Genital herpes simplex 34.06 18.11 10 25671 522 110563096
Liver transplant rejection 33.69 18.11 17 25664 3901 110559717
Urticaria 32.09 18.11 17 25664 318840 110244778
Hypertension 31.99 18.11 43 25638 510041 110053577
Portal hypertensive gastropathy 31.37 18.11 13 25668 1895 110561723
Sunburn 31.30 18.11 17 25664 4531 110559087
Genital herpes 30.89 18.11 14 25667 2533 110561085
Thought blocking 30.88 18.11 8 25673 261 110563357
Duodenal ulcer perforation 30.43 18.11 3 25678 177697 110385921
Gastric varices haemorrhage 30.25 18.11 9 25672 492 110563126
Chills 30.04 18.11 105 25576 190475 110373143
Mobility decreased 29.86 18.11 9 25672 237413 110326205
C-reactive protein increased 29.80 18.11 7 25674 217912 110345706
Hepatitis B 28.31 18.11 21 25660 9591 110554027
Arthritis 28.25 18.11 3 25678 167583 110396035
Hepatic neoplasm 28.14 18.11 15 25666 3852 110559766
Pericarditis 28.12 18.11 8 25673 219106 110344512
Pulmonary arterial hypertension 27.75 18.11 36 25645 32532 110531086
Irritable bowel syndrome 27.53 18.11 3 25678 164212 110399406
Discomfort 27.26 18.11 8 25673 214699 110348919
Bleeding varicose vein 27.13 18.11 9 25672 704 110562914
Choroiditis 26.54 18.11 11 25670 1604 110562014
Peripheral swelling 26.41 18.11 33 25648 404001 110159617
Swelling 25.87 18.11 26 25655 351015 110212603
Musculoskeletal stiffness 25.23 18.11 17 25664 279805 110283813
Acute leukaemia 25.11 18.11 11 25670 1838 110561780
Hypotension 24.71 18.11 53 25628 523796 110039822
Hydrocholecystis 24.58 18.11 8 25673 589 110563029
Bacterascites 24.46 18.11 4 25677 10 110563608
Sinus bradycardia 24.20 18.11 32 25649 29451 110534167
Injection site pain 23.76 18.11 6 25675 177916 110385702
Stomatitis 23.59 18.11 17 25664 270225 110293393
Coma hepatic 23.50 18.11 9 25672 1068 110562550
Biliary colic 23.10 18.11 14 25667 4583 110559035
Transcatheter arterial chemoembolisation 23.04 18.11 4 25677 16 110563602
Incorrect product administration duration 22.91 18.11 26 25655 20472 110543146
Porphyria non-acute 22.72 18.11 8 25673 749 110562869
Haemolytic anaemia 22.48 18.11 26 25655 20894 110542724
Urinary tract disorder 22.40 18.11 15 25666 5829 110557789
Fibromyalgia 22.38 18.11 6 25675 170903 110392715
Ammonia increased 22.03 18.11 17 25664 8233 110555385
Inappropriate schedule of product administration 21.78 18.11 10 25671 203627 110359991
Haemorrhagic stroke 21.70 18.11 21 25660 13768 110549850
Gait inability 21.62 18.11 3 25678 136373 110427245
Completed suicide 21.48 18.11 15 25666 242366 110321252
Contusion 21.27 18.11 14 25667 233347 110330271
Malignant neoplasm progression 21.27 18.11 7 25674 174560 110389058
Drug resistance 21.25 18.11 43 25638 56331 110507287
Mesenteric vein thrombosis 21.19 18.11 10 25671 1985 110561633
Fibrosis 20.96 18.11 16 25665 7626 110555992
Gene mutation identification test positive 20.61 18.11 6 25675 304 110563314
Anal pruritus 20.05 18.11 8 25673 1059 110562559
Genotype drug resistance test 20.03 18.11 3 25678 3 110563615
Portopulmonary hypertension 19.61 18.11 5 25676 153 110563465
Hepatitis C RNA 19.46 18.11 4 25677 45 110563573
Ocular discomfort 19.41 18.11 16 25665 8517 110555101
Soft tissue infection 19.32 18.11 13 25668 5094 110558524
Pruritus 19.22 18.11 213 25468 581347 109982271
Lower respiratory tract infection 19.08 18.11 17 25664 243089 110320529
Pathogen resistance 19.05 18.11 22 25659 17650 110545968
Generalised oedema 18.83 18.11 29 25652 30675 110532943
Blood bilirubin abnormal 18.81 18.11 9 25672 1841 110561777
Loss of personal independence in daily activities 18.30 18.11 6 25675 150014 110413604
Exposure during pregnancy 18.25 18.11 8 25673 167416 110396202
Psychotic disorder 18.19 18.11 38 25643 50899 110512719
Hepatic enzyme increased 18.19 18.11 29 25652 320863 110242755
Hepatitis B DNA increased 18.14 18.11 7 25674 848 110562770

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AP08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
ATC J05AP51 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
ATC J05AP55 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
ATC J05AP56 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
FDA MoA N0000191258 RNA Replicase Inhibitors
FDA EPC N0000191493 Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:64924 hepatitis C protease inhibitor
CHEBI has role CHEBI:64951 anti-HBV agent

Related Drugs by ATC class:

J05AP Antivirals for treatment of HCV infections 18 drugs
asunaprevirbeclabuvirboceprevirdaclatasvirdasabuvirelbasvirglecaprevirgrazoprevirledipasvirombitasvirparitaprevirpibrentasvir show all 18 →

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

DiseaseRelationSNOMED_IDDOID
Chronic hepatitis C indication 128302006
Compensated cirrhosis indication 371139006
Decompensated cirrhosis of liver indication 716203000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.07 acidic
pKa2 11.58 acidic
pKa3 2.07 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8334270 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8334270 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8580765 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8580765 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8735372 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8735372 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8957046 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8957046 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9085573 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9085573 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8334270 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8580765 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8735372 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9085573 March 21, 2028 FOR THE TREATMENT OF HEPATITIS C
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 9549941 March 26, 2029 FOR THE TREATMENT OF GENOTYPE 1, 2, 3 OR 4 CHRONIC HEPATITIS C VIRUS (HCV) INFECTION AS A COMPONENT OF A COMBINATION ANTIVIRAL TREATMENT REGIMEN WITH RIBAVIRIN
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 7964580 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 7964580 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8633309 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8633309 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8889159 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8889159 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 7964580 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8633309 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8889159 March 26, 2029 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8273341 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8822430 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8841278 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 9511056 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8273341 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8822430 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8841278 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 9511056 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8273341 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8822430 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8841278 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9511056 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8273341 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8822430 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8841278 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9511056 May 12, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9284342 Sept. 13, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9284342 Sept. 13, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 9284342 Sept. 13, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8618076 Dec. 11, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8618076 Dec. 11, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8618076 Dec. 11, 2030 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 9393256 Sept. 14, 2032 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 9393256 Sept. 14, 2032 FOR THE TREATMENT OF HEPATITIS C
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9393256 Sept. 14, 2032 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL 9393256 Sept. 14, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8575135 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8575135 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8921341 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8921341 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8940718 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8940718 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8575135 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8921341 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 8940718 Nov. 16, 2032 FOR THE TREATMENT OF HEPATITIS C
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL 10039779 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 10039779 Jan. 30, 2034 FOR THE TREATMENT OF GENOTYPE 1, 4, 5 OR 6 CHRONIC HEPATITIS C VIRUS (HCV) INFECTION
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL 10039779 Jan. 30, 2034 FOR TREATMENT-NAIVE GENOTYPE 1 PATIENTS WITH CHRONIC HEPATITIS C VIRUS (HCV) INFECTION FOR A DURATION OF 8-WEEKS
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 10086011 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 10086011 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11116783 Jan. 30, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11116783 Jan. 30, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 11707479 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 11116783 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL 11707479 Jan. 30, 2034 FOR THE TREATMENT OF HEPATITIS C
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11338007 June 1, 2037 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11338007 June 1, 2037 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL Aug. 28, 2026 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL Aug. 28, 2026 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL Aug. 28, 2026 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL Aug. 28, 2026 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH DECOMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 OR 4 INFECTION WHO ARE LIVER TRANSPLANT RECIPIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
33.75MG;150MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH DECOMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 OR 4 INFECTION WHO ARE LIVER TRANSPLANT RECIPIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
45MG;200MG/PACKET HARVONI GILEAD SCIENCES INC N212477 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL Aug. 28, 2026 FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL March 19, 2027 TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL March 19, 2027 TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL March 19, 2027 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Sept. 19, 2027 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Sept. 19, 2027 PEDIATRIC EXCLUSIVITY
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL Sept. 19, 2027 PEDIATRIC EXCLUSIVITY
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL June 10, 2028 FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
NS5B protein Enzyme INHIBITOR EC50 7.19 CHEMBL CHEMBL
Genome polyprotein Polyprotein INHIBITOR EC90 6.96 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Cereblon isoform 4 Cytosolic other Ki 4.66 CHEMBL
RNA-directed RNA polymerase Enzyme EC50 7.36 CHEMBL
NS5 Enzyme EC50 6.92 CHEMBL

External reference:

IDSource
D10366 KEGG_DRUG
4032949 VUID
N0000189539 NUI
4032949 VANDF
WG6 PDB_CHEM_ID
CHEMBL1259059 ChEMBL_ID
7368 IUPHAR_LIGAND_ID
DB08934 DRUGBANK_ID
WJ6CA3ZU8B UNII
1484911 RXNORM
207812 MMSL
29932 MMSL
d08184 MMSL
015326 NDDF
710806008 SNOMEDCT_US
713645002 SNOMEDCT_US
C2976303 UMLSCUI
D000069474 MESH_DESCRIPTOR_UI
C4278437 UMLSCUI
CHEBI:85083 CHEBI
9665 INN_ID
45375808 PUBCHEM_CID
11311503 PUBCHEM_CID
C000608248 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1501 TABLET, FILM COATED 400 mg ORAL NDA 33 sections
Sovaldi Access HUMAN PRESCRIPTION DRUG LABEL 1 61958-1502 TABLET, FILM COATED 400 mg ORAL Export only 34 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1503 TABLET, FILM COATED 200 mg ORAL NDA 33 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1504 PELLET 150 mg ORAL NDA 33 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1505 PELLET 200 mg ORAL NDA 33 sections
Harvoni HUMAN PRESCRIPTION DRUG LABEL 2 61958-1801 TABLET, FILM COATED 400 mg ORAL NDA 35 sections
Harvoni Access HUMAN PRESCRIPTION DRUG LABEL 2 61958-1802 TABLET, FILM COATED 400 mg ORAL Export only 31 sections
Harvoni HUMAN PRESCRIPTION DRUG LABEL 2 61958-1803 TABLET, FILM COATED 200 mg ORAL NDA 35 sections
Harvoni HUMAN PRESCRIPTION DRUG LABEL 2 61958-1804 PELLET 200 mg ORAL NDA 35 sections
Harvoni HUMAN PRESCRIPTION DRUG LABEL 2 61958-1805 PELLET 150 mg ORAL NDA 35 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2201 TABLET, FILM COATED 400 mg ORAL NDA 36 sections
Epclusa Access HUMAN PRESCRIPTION DRUG LABEL 2 61958-2202 TABLET, FILM COATED 400 mg ORAL Export only 31 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2203 TABLET, FILM COATED 200 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2204 PELLET 200 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2205 PELLET 150 mg ORAL NDA 36 sections
Vosevi HUMAN PRESCRIPTION DRUG LABEL 3 61958-2401 TABLET, FILM COATED 400 mg ORAL NDA 34 sections
Ledipasvir and Sofosbuvir HUMAN PRESCRIPTION DRUG LABEL 2 72626-2601 TABLET, FILM COATED 400 mg ORAL NDA AUTHORIZED GENERIC 34 sections
Sofosbuvir and Velpatasvir HUMAN PRESCRIPTION DRUG LABEL 2 72626-2701 TABLET, FILM COATED 400 mg ORAL NDA AUTHORIZED GENERIC 35 sections