sofosbuvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals RNA polymerase (NS5B) inhibitors | 4811 | 1190307-88-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.07 | acidic |
| pKa2 | 11.58 | acidic |
| pKa3 | 2.07 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |