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

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 758.63 21.89 151 10524 2043 63476304
Hepatitis C 688.99 21.89 163 10512 5111 63473236
Anaemia 297.51 21.89 302 10373 293128 63185219
Hepatic encephalopathy 195.60 21.89 73 10602 11209 63467138
Fatigue 156.72 21.89 410 10265 887618 62590729
Hepatitis B reactivation 155.71 21.89 45 10630 3092 63475255
Hepatic cirrhosis 155.07 21.89 78 10597 24656 63453691
Ascites 154.19 21.89 92 10583 40636 63437711
Genotype drug resistance test positive 144.74 21.89 29 10646 404 63477943
Hyperbilirubinaemia 135.45 21.89 56 10619 11258 63467089
Hepatic failure 110.69 21.89 71 10604 35585 63442762
Viral load increased 106.60 21.89 28 10647 1346 63477001
Headache 95.70 21.89 277 10398 632964 62845383
Oesophageal varices haemorrhage 95.03 21.89 25 10650 1209 63477138
Hepatitis C RNA positive 85.77 21.89 14 10661 53 63478294
Haemoglobin decreased 84.75 21.89 113 10562 145372 63332975
Blood bilirubin increased 82.14 21.89 60 10615 37080 63441267
Insomnia 75.43 21.89 132 10543 215120 63263227
Cryoglobulinaemia 74.30 21.89 17 10658 456 63477891
Viral mutation identified 72.50 21.89 22 10653 1788 63476559
Jaundice 70.97 21.89 50 10625 29201 63449146
Photosensitivity reaction 67.67 21.89 38 10637 14956 63463391
Liver transplant 63.37 21.89 21 10654 2270 63476077
Nausea 61.27 21.89 294 10381 854177 62624170
Hepatic cancer recurrent 60.63 21.89 10 10665 41 63478306
Hepatitis C RNA increased 56.41 21.89 11 10664 132 63478215
Influenza like illness 53.55 21.89 61 10614 66763 63411584
Portal vein thrombosis 52.91 21.89 19 10656 2611 63475736
Treatment failure 52.26 21.89 108 10567 198935 63279412
Virologic failure 51.23 21.89 17 10658 1845 63476502
Drug interaction 48.47 21.89 114 10561 229017 63249330
Off label use 45.26 21.89 228 10447 674234 62804113
Sunburn 44.53 21.89 17 10658 2771 63475576
Drug ineffective 44.36 21.89 313 10362 1044452 62433895
Renal impairment 41.54 21.89 62 10613 88293 63390054
Exposure via partner 39.37 21.89 8 10667 120 63478227
Drug intolerance 37.75 21.89 4 10671 308657 63169690
Exposure via body fluid 35.81 21.89 10 10665 606 63477741
Drug hypersensitivity 35.61 21.89 5 10670 310682 63167665
Drug resistance 35.44 21.89 30 10645 22903 63455444
Hepatorenal syndrome 35.29 21.89 13 10662 1919 63476428
Hepatic cancer 33.64 21.89 16 10659 4471 63473876
Remission not achieved 33.35 21.89 7 10668 124 63478223
Asthenia 32.49 21.89 139 10536 383465 63094882
Varices oesophageal 32.39 21.89 14 10661 3134 63475213
Blood bilirubin abnormal 30.96 21.89 10 10665 997 63477350
Pain 29.17 21.89 50 10625 740578 62737769
Hepatitis C virus test positive 28.71 21.89 6 10669 104 63478243
Joint swelling 28.13 21.89 10 10665 327656 63150691
Rheumatoid arthritis 27.02 21.89 5 10670 253814 63224533
Arthropathy 26.38 21.89 4 10671 234788 63243559
Chills 25.67 21.89 58 10617 113320 63365027
Glomerulonephritis 25.25 21.89 10 10665 1796 63476551
Hepatectomy 24.48 21.89 5 10670 77 63478270
Sinus node dysfunction 24.24 21.89 13 10662 4672 63473675
Depression 23.89 21.89 80 10595 196412 63281935
Irritability 23.81 21.89 28 10647 31666 63446681
Complications of transplanted lung 23.37 21.89 6 10669 263 63478084
Exposure via father 23.31 21.89 6 10669 266 63478081
Transcatheter arterial chemoembolisation 23.07 21.89 3 10672 0 63478347
Toxicity to various agents 22.16 21.89 7 10668 247243 63231104

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 2001.81 17.84 540 17230 9290 34929871
Hepatocellular carcinoma 1948.37 17.84 500 17270 7009 34932152
Treatment failure 867.44 17.84 438 17332 46259 34892902
Genotype drug resistance test positive 723.07 17.84 157 17613 988 34938173
Drug ineffective 675.13 17.84 977 16793 455774 34483387
Hepatic encephalopathy 335.44 17.84 159 17611 14526 34924635
Hepatic cirrhosis 316.40 17.84 161 17609 17153 34922008
Liver transplant 272.59 17.84 85 17685 2449 34936712
Ascites 232.25 17.84 191 17579 46380 34892781
Fatigue 231.35 17.84 550 17220 370103 34569058
Headache 192.84 17.84 356 17414 200279 34738882
Hepatic failure 177.06 17.84 144 17626 34387 34904774
Hyperbilirubinaemia 172.06 17.84 107 17663 16736 34922425
Hepatic cancer 160 17.84 80 17690 8195 34930966
Hepatitis C RNA positive 155.91 17.84 32 17738 146 34939015
Insomnia 141.79 17.84 216 17554 103691 34835470
Viral mutation identified 141.03 17.84 54 17716 2900 34936261
Anaemia 138.05 17.84 340 17430 232995 34706166
Virologic failure 135.88 17.84 55 17715 3425 34935736
Hepatitis C RNA increased 123.85 17.84 29 17741 266 34938895
Oesophageal varices haemorrhage 116.94 17.84 48 17722 3098 34936063
Jaundice 109.50 17.84 106 17664 31776 34907385
Hepatic hydrothorax 108.34 17.84 19 17751 27 34939134
Hepatitis B reactivation 107.12 17.84 48 17722 3843 34935318
Hepatic cancer recurrent 105.87 17.84 26 17744 297 34938864
Blood bilirubin increased 91.62 17.84 105 17665 38191 34900970
Hepatorenal syndrome 86.75 17.84 37 17733 2629 34936532
Peritonitis bacterial 86.58 17.84 48 17722 6062 34933099
Toxicity to various agents 68.88 17.84 10 17760 200352 34738809
Irritability 62.95 17.84 70 17700 24620 34914541
Viral load increased 62.70 17.84 29 17741 2498 34936663
Portal vein thrombosis 59.89 17.84 32 17738 3756 34935405
Influenza like illness 58.18 17.84 71 17699 27563 34911598
Therapeutic embolisation 57.54 17.84 16 17754 305 34938856
Varices oesophageal 54.57 17.84 30 17740 3725 34935436
Bleeding varicose vein 52.13 17.84 15 17755 325 34938836
Off label use 51.24 17.84 376 17394 419148 34520013
Hypotension 44.51 17.84 29 17741 221620 34717541
Hepatitis C virus test positive 42.65 17.84 13 17757 346 34938815
Haemoglobin decreased 41.21 17.84 145 17625 120627 34818534
Remission not achieved 41.14 17.84 10 17760 109 34939052
Genital herpes simplex 40.34 17.84 10 17760 119 34939042
Complications of transplanted lung 39.69 17.84 11 17759 207 34938954
Febrile neutropenia 38.37 17.84 11 17759 136838 34802323
Product quality issue 37.86 17.84 45 17725 16990 34922171
Drug abuse 36.30 17.84 4 17766 99092 34840069
Depression 36.11 17.84 120 17650 96978 34842183
Photosensitivity reaction 35.92 17.84 35 17735 10559 34928602
Biliary colic 32.12 17.84 14 17756 1048 34938113
Nausea 30.26 17.84 284 17486 339624 34599537
Thought blocking 29.91 17.84 8 17762 131 34939030
Portal hypertension 29.78 17.84 21 17749 4041 34935120
Diabetic hyperglycaemic coma 28.15 17.84 6 17764 34 34939127
Genital herpes 28.14 17.84 11 17759 624 34938537
Drug hypersensitivity 27.67 17.84 4 17766 80525 34858636
Encephalopathy 26.85 17.84 57 17713 35262 34903899
Malignant neoplasm progression 26.74 17.84 6 17764 88040 34851121
Incorrect product administration duration 26.61 17.84 21 17749 4790 34934371
Liver transplant rejection 25.59 17.84 15 17755 2104 34937057
Abdominal cavity drainage 24.99 17.84 9 17761 406 34938755
Hepatic neoplasm 23.89 17.84 14 17756 1963 34937198
Liver disorder 23.64 17.84 52 17718 32945 34906216
Product dose omission issue 21.76 17.84 119 17651 119592 34819569
Fall 21.75 17.84 44 17726 202841 34736320
Choroiditis 21.30 17.84 11 17759 1204 34937957
Cryoglobulinaemia 20.58 17.84 8 17762 447 34938714
Hydrocholecystis 20.33 17.84 8 17762 462 34938699
Coma hepatic 20.25 17.84 8 17762 467 34938694
Tachycardia 20.03 17.84 9 17761 84763 34854398
Porphyria non-acute 20.02 17.84 8 17762 481 34938680
Gene mutation identification test positive 19.96 17.84 6 17764 152 34939009
Sunburn 19.66 17.84 12 17758 1811 34937350
General physical health deterioration 19.35 17.84 22 17748 128247 34810914
Hepatitis C RNA 19.35 17.84 4 17766 19 34939142
Hepatectomy 19.29 17.84 5 17765 72 34939089
Hyponatraemia 19.19 17.84 9 17761 82682 34856479
Pulmonary embolism 19.01 17.84 11 17759 89735 34849426
Pregnancy of partner 18.96 17.84 7 17763 339 34938822
Dysentery 18.60 17.84 7 17763 358 34938803
Viral test positive 18.34 17.84 6 17764 202 34938959

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 2455.79 17.62 598 24066 11327 79708397
Hepatocellular carcinoma 2375.64 17.62 552 24112 8469 79711255
Genotype drug resistance test positive 626.95 17.62 131 24533 1177 79718547
Hepatic encephalopathy 482.13 17.62 205 24459 23961 79695763
Hepatic cirrhosis 463.96 17.62 223 24441 34683 79685041
Treatment failure 425.42 17.62 380 24284 170106 79549618
Anaemia 394.47 17.62 579 24085 444436 79275288
Drug ineffective 392.93 17.62 958 23706 1079955 78639769
Ascites 381.26 17.62 256 24408 75306 79644418
Fatigue 363.13 17.62 848 23816 928879 78790845
Hyperbilirubinaemia 305.70 17.62 150 24514 24368 79695356
Liver transplant 296.71 17.62 92 24572 4331 79715393
Hepatic failure 279.33 17.62 195 24469 61017 79658707
Oesophageal varices haemorrhage 225.93 17.62 74 24590 4162 79715562
Viral mutation identified 224.50 17.62 72 24592 3786 79715938
Insomnia 222.16 17.62 323 24341 244847 79474877
Hepatitis C RNA positive 222.11 17.62 42 24622 211 79719513
Hepatitis B reactivation 214.21 17.62 78 24586 6030 79713694
Hepatic cancer 208.82 17.62 89 24575 10440 79709284
Headache 208.09 17.62 553 24111 653219 79066505
Virologic failure 171.46 17.62 60 24604 4131 79715593
Jaundice 169.77 17.62 137 24527 53212 79666512
Hepatic cancer recurrent 157.64 17.62 32 24632 245 79719479
Blood bilirubin increased 140.31 17.62 135 24529 66097 79653627
Hepatitis C RNA increased 139.17 17.62 31 24633 385 79719339
Hepatorenal syndrome 122.47 17.62 47 24617 4202 79715522
Hepatic hydrothorax 121.18 17.62 21 24643 57 79719667
Haemoglobin decreased 109.94 17.62 224 24440 221895 79497829
Peritonitis bacterial 108.75 17.62 55 24609 9512 79710212
Viral load increased 108.42 17.62 39 24625 2909 79716815
Portal vein thrombosis 108.12 17.62 47 24617 5780 79713944
Cryoglobulinaemia 94.24 17.62 26 24638 807 79718917
Toxicity to various agents 90.04 17.62 12 24652 421528 79298196
Irritability 89.25 17.62 85 24579 41059 79678665
Influenza like illness 86.89 17.62 109 24555 71598 79648126
Varices oesophageal 84.77 17.62 40 24624 5951 79713773
Therapeutic embolisation 67.68 17.62 18 24646 485 79719239
Drug hypersensitivity 67.53 17.62 7 24657 298909 79420815
Complications of transplanted lung 63.96 17.62 17 24647 457 79719267
Remission not achieved 61.57 17.62 16 24648 393 79719331
Nausea 59.48 17.62 501 24163 956695 78763029
Depression 55.43 17.62 170 24494 216620 79503104
Renal impairment 52.34 17.62 136 24528 157647 79562077
Hepatitis C virus test positive 51.75 17.62 14 24650 403 79719321
Joint swelling 51.35 17.62 13 24651 288633 79431091
Photosensitivity reaction 48.40 17.62 45 24619 21082 79698642
Portal hypertension 48.02 17.62 29 24635 7079 79712645
Encephalopathy 41.93 17.62 75 24589 67322 79652402
Hepatectomy 40.87 17.62 10 24654 191 79719533
Rheumatoid arthritis 39.85 17.62 8 24656 208462 79511262
Therapeutic product effect decreased 39.25 17.62 3 24661 163860 79555864
Arthropathy 37.86 17.62 5 24659 177106 79542618
Product dose omission issue 36.89 17.62 163 24501 247374 79472350
Completed suicide 36.75 17.62 15 24649 245752 79473972
Drug intolerance 36.55 17.62 18 24646 264101 79455623
Pain 36.39 17.62 105 24559 703697 79016027
Febrile neutropenia 36.36 17.62 13 24651 230986 79488738
Hypersensitivity 36.09 17.62 18 24646 262221 79457503
Drug interaction 35.06 17.62 234 24430 414949 79304775
Genital herpes simplex 34.48 17.62 10 24654 373 79719351
Abdominal cavity drainage 34.40 17.62 12 24652 818 79718906
Hypotension 34.27 17.62 52 24612 440265 79279459
Therapeutic product effect incomplete 32.80 17.62 3 24661 141642 79578082
Asthenia 32.75 17.62 270 24394 511419 79208305
Contraindicated product administered 32.38 17.62 5 24659 157533 79562191
Liver transplant rejection 32.10 17.62 17 24647 3231 79716493
Renal failure 31.97 17.62 135 24529 200833 79518891
Sinus node dysfunction 31.55 17.62 23 24641 7678 79712046
Portal hypertensive gastropathy 31.54 17.62 13 24651 1401 79718323
Nasopharyngitis 31.24 17.62 20 24644 253861 79465863
Condition aggravated 31.12 17.62 68 24596 501056 79218668
Sinusitis 30.77 17.62 11 24653 195490 79524234
Genital herpes 29.74 17.62 14 24650 2070 79717654
Thought blocking 29.52 17.62 8 24656 232 79719492
Sunburn 29.46 17.62 17 24647 3816 79715908
Gastric varices haemorrhage 28.78 17.62 9 24655 435 79719289
Incorrect product administration duration 28.29 17.62 26 24638 11996 79707728
Weight increased 27.65 17.62 27 24637 277359 79442365
Malignant neoplasm progression 26.44 17.62 5 24659 135985 79583739
Asthma 26.20 17.62 5 24659 135090 79584634
Bleeding varicose vein 25.85 17.62 9 24655 610 79719114
Hepatic neoplasm 25.82 17.62 15 24649 3411 79716313
Fall 25.71 17.62 72 24592 487557 79232167
Hepatitis B 25.64 17.62 21 24643 8311 79711413
Choroiditis 25.16 17.62 11 24653 1370 79718354
Arthritis 25.14 17.62 3 24661 114877 79604847
Myalgia 24.49 17.62 118 24546 185523 79534201
Product use in unapproved indication 24.23 17.62 25 24639 250334 79469390
Drug abuse 24.19 17.62 10 24654 162681 79557043
Hypertension 23.93 17.62 41 24623 330951 79388773
Haematemesis 23.79 17.62 51 24613 52213 79667511
Pulmonary arterial hypertension 23.61 17.62 36 24628 28330 79691394
Bacterascites 23.32 17.62 4 24660 10 79719714
Hydrocholecystis 23.22 17.62 8 24656 525 79719199
Acute leukaemia 22.82 17.62 11 24653 1715 79718009
Injection site pain 22.78 17.62 6 24658 129832 79589892
Transcatheter arterial chemoembolisation 21.89 17.62 4 24660 16 79719708
Biliary colic 21.33 17.62 14 24650 3948 79715776
Drug resistance 21.33 17.62 43 24621 42170 79677554
Wheezing 21.22 17.62 5 24659 116659 79603065
C-reactive protein increased 20.74 17.62 7 24657 129020 79590704
Coma hepatic 20.72 17.62 9 24655 1104 79718620
Liver disorder 20.57 17.62 59 24605 72358 79647366
Porphyria non-acute 20.57 17.62 8 24656 741 79718983
Hepatitis C RNA 20.41 17.62 4 24660 25 79719699
Pruritus 19.96 17.62 198 24466 394450 79325274
Gene mutation identification test positive 19.93 17.62 6 24658 255 79719469
Haemolytic anaemia 19.85 17.62 26 24638 17794 79701930
Peripheral swelling 19.85 17.62 33 24631 269584 79450140
Urticaria 19.66 17.62 17 24647 185184 79534540
Sinus bradycardia 19.56 17.62 31 24633 25216 79694508
Blood pressure increased 19.45 17.62 22 24642 211338 79508386
Mesenteric vein thrombosis 19.30 17.62 10 24654 1817 79717907
Genotype drug resistance test 19.17 17.62 3 24661 3 79719721
Ammonia increased 18.92 17.62 17 24647 7618 79712106
Off label use 18.91 17.62 389 24275 906826 78812898
Blood bilirubin abnormal 18.35 17.62 9 24655 1456 79718268
Discomfort 18.23 17.62 8 24656 125609 79594115
Portopulmonary hypertension 17.74 17.62 5 24659 168 79719556

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:36044 antiviral drugs
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:64924 hepatitis C protease inhibitors

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
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9585906 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 9585906 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
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS 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 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;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL March 19, 2023 NEW STRENGTH
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL March 19, 2023 NEW PATIENT POPULATION
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL May 15, 2023 PEDIATRIC EXCLUSIVITY
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL July 14, 2023 INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL July 14, 2023 INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Sept. 19, 2023 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Sept. 19, 2023 PEDIATRIC EXCLUSIVITY
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Jan. 14, 2024 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Jan. 14, 2024 PEDIATRIC EXCLUSIVITY
200MG SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL April 7, 2024 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 April 7, 2024 TREATMENT OF CHRONIC HCV GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL April 7, 2024 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 April 7, 2024 TREATMENT OF PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITH CHRONIC HEPATITIS C VIRUS 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 April 7, 2024 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/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL April 7, 2024 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 SOVALDI GILEAD SCIENCES INC N204671 Aug. 28, 2019 RX TABLET ORAL Oct. 7, 2024 PEDIATRIC EXCLUSIVITY
400MG SOVALDI GILEAD SCIENCES INC N204671 Dec. 6, 2013 RX TABLET ORAL Oct. 7, 2024 PEDIATRIC EXCLUSIVITY
45MG;200MG HARVONI GILEAD SCIENCES INC N205834 Aug. 28, 2019 RX TABLET ORAL Oct. 7, 2024 PEDIATRIC EXCLUSIVITY
90MG;400MG HARVONI GILEAD SCIENCES INC N205834 Oct. 10, 2014 RX TABLET ORAL Oct. 7, 2024 PEDIATRIC EXCLUSIVITY
150MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL Oct. 7, 2024 PEDIATRIC EXCLUSIVITY
200MG/PACKET SOVALDI GILEAD SCIENCES INC N212480 Aug. 28, 2019 RX PELLETS ORAL Oct. 7, 2024 PEDIATRIC EXCLUSIVITY
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
200MG;50MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL April 27, 2025 UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
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 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 EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET 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
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET 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 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
200MG;50MG/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
200MG;50MG EPCLUSA GILEAD SCIENCES INC N208341 March 19, 2020 RX TABLET ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY
400MG;100MG EPCLUSA GILEAD SCIENCES INC N208341 June 28, 2016 RX TABLET ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY
150MG;37.5MG/PACKET EPCLUSA GILEAD SCIENCES INC N214187 June 10, 2021 RX PELLETS ORAL Dec. 10, 2028 PEDIATRIC EXCLUSIVITY
200MG;50MG/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 Unclassified Ki 4.66 CHEMBL
NS5 Unclassified EC50 6.92 CHEMBL

External reference:

IDSource
D10366 KEGG_DRUG
4032949 VUID
N0000189539 NUI
4032949 VANDF
CHEBI:85083 CHEBI
WG6 PDB_CHEM_ID
CHEMBL1259059 ChEMBL_ID
C000608248 MESH_SUPPLEMENTAL_RECORD_UI
7368 IUPHAR_LIGAND_ID
9665 INN_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
45375808 PUBCHEM_CID
11311503 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1501 TABLET, FILM COATED 400 mg ORAL NDA 34 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1501 TABLET, FILM COATED 400 mg ORAL NDA 34 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 34 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1503 TABLET, FILM COATED 200 mg ORAL NDA 34 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1504 PELLET 150 mg ORAL NDA 34 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1504 PELLET 150 mg ORAL NDA 34 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1505 PELLET 200 mg ORAL NDA 34 sections
Sovaldi HUMAN PRESCRIPTION DRUG LABEL 1 61958-1505 PELLET 200 mg ORAL NDA 34 sections
Harvoni HUMAN PRESCRIPTION DRUG LABEL 2 61958-1801 TABLET, FILM COATED 400 mg ORAL NDA 36 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 36 sections
Harvoni HUMAN PRESCRIPTION DRUG LABEL 2 61958-1804 PELLET 200 mg ORAL NDA 36 sections
Harvoni HUMAN PRESCRIPTION DRUG LABEL 2 61958-1805 PELLET 150 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2201 TABLET, FILM COATED 400 mg ORAL NDA 36 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 61958-2203 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 61958-2204 PELLET 200 mg ORAL NDA 36 sections
Epclusa HUMAN PRESCRIPTION DRUG LABEL 2 61958-2205 PELLET 150 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 35 sections
Sofosbuvir and Velpatasvir HUMAN PRESCRIPTION DRUG LABEL 2 72626-2701 TABLET, FILM COATED 400 mg ORAL NDA AUTHORIZED GENERIC 35 sections
Sofosbuvir and Velpatasvir HUMAN PRESCRIPTION DRUG LABEL 2 72626-2701 TABLET, FILM COATED 400 mg ORAL NDA AUTHORIZED GENERIC 35 sections