ledipasvir Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals, hepatitis C Virus (HCV) NS5A inhibitors | 4899 | 1256388-51-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
an inhibitor of the HCV NS5A protein, which is required for viral replication
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Hosey CM, Chan R, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 4, 2014 | EMA | ||
| Oct. 10, 2014 | FDA | GILEAD SCIENCES INC |
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 |
|---|---|---|---|---|---|---|
| Headache | 2013.61 | 21.17 | 1408 | 12806 | 535413 | 52799439 |
| Fatigue | 1538.65 | 21.17 | 1365 | 12849 | 729141 | 52605711 |
| Hepatocellular carcinoma | 749.23 | 21.17 | 172 | 14042 | 2908 | 53331944 |
| Hepatitis C | 630.87 | 21.17 | 174 | 14040 | 6327 | 53328525 |
| Insomnia | 242.88 | 21.17 | 273 | 13941 | 186799 | 53148053 |
| Genotype drug resistance test positive | 204.59 | 21.17 | 44 | 14170 | 540 | 53334312 |
| Nausea | 171.46 | 21.17 | 513 | 13701 | 755578 | 52579274 |
| Hepatic encephalopathy | 134.11 | 21.17 | 63 | 14151 | 10796 | 53324056 |
| Product dose omission issue | 124.93 | 21.17 | 200 | 14014 | 191420 | 53143432 |
| Hepatitis C virus test positive | 124.58 | 21.17 | 24 | 14190 | 161 | 53334691 |
| Ascites | 111.29 | 21.17 | 89 | 14125 | 39646 | 53295206 |
| Oesophageal varices haemorrhage | 105.31 | 21.17 | 30 | 14184 | 1223 | 53333629 |
| Diarrhoea | 81.36 | 21.17 | 355 | 13859 | 625191 | 52709661 |
| Hepatic cancer recurrent | 81.35 | 21.17 | 14 | 14200 | 44 | 53334808 |
| Dyspepsia | 76.94 | 21.17 | 99 | 14115 | 77501 | 53257351 |
| Hepatitis B reactivation | 67.84 | 21.17 | 24 | 14190 | 1984 | 53332868 |
| Rheumatoid arthritis | 64.93 | 21.17 | 5 | 14209 | 314526 | 53020326 |
| Hepatic cirrhosis | 56.12 | 21.17 | 43 | 14171 | 17979 | 53316873 |
| Hepatic cancer | 51.67 | 21.17 | 23 | 14191 | 3478 | 53331374 |
| Drug hypersensitivity | 50.02 | 21.17 | 6 | 14208 | 265236 | 53069616 |
| Product use complaint | 44.48 | 21.17 | 18 | 14196 | 2152 | 53332700 |
| Glomerular filtration rate decreased | 40.93 | 21.17 | 31 | 14183 | 12736 | 53322116 |
| Treatment failure | 36.37 | 21.17 | 95 | 14119 | 128308 | 53206544 |
| Liver transplant | 35.57 | 21.17 | 16 | 14198 | 2478 | 53332374 |
| Toxicity to various agents | 34.68 | 21.17 | 8 | 14206 | 219590 | 53115262 |
| Hepatic failure | 34.39 | 21.17 | 45 | 14169 | 35761 | 53299091 |
| Portal vein thrombosis | 31.72 | 21.17 | 15 | 14199 | 2604 | 53332248 |
| Neutropenia | 31.52 | 21.17 | 3 | 14211 | 159182 | 53175670 |
| Off label use | 30.82 | 21.17 | 49 | 14165 | 472163 | 52862689 |
| Irritability | 28.33 | 21.17 | 38 | 14176 | 30915 | 53303937 |
| Pruritus | 25.36 | 21.17 | 149 | 14065 | 293683 | 53041169 |
| Renal impairment | 24.97 | 21.17 | 63 | 14151 | 83255 | 53251597 |
| Cryoglobulinaemia | 24.28 | 21.17 | 8 | 14206 | 533 | 53334319 |
| Varices oesophageal | 24.01 | 21.17 | 13 | 14201 | 2999 | 53331853 |
| Swelling | 23.12 | 21.17 | 11 | 14203 | 191094 | 53143758 |
| Hypersensitivity | 22.75 | 21.17 | 14 | 14200 | 210651 | 53124201 |
| Arthropathy | 22.63 | 21.17 | 5 | 14209 | 141448 | 53193404 |
| Infection | 22.27 | 21.17 | 9 | 14205 | 172196 | 53162656 |
| Abnormal dreams | 21.98 | 21.17 | 20 | 14194 | 10581 | 53324271 |
| Complications of transplanted lung | 21.27 | 21.17 | 6 | 14208 | 236 | 53334616 |
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 |
|---|---|---|---|---|---|---|
| Headache | 3088.06 | 18.62 | 1728 | 17926 | 194469 | 32299403 |
| Fatigue | 3034.35 | 18.62 | 2105 | 17549 | 348596 | 32145276 |
| Hepatitis C | 1960.39 | 18.62 | 592 | 19062 | 12926 | 32480946 |
| Hepatocellular carcinoma | 1143.82 | 18.62 | 368 | 19286 | 9902 | 32483970 |
| Treatment failure | 492.57 | 18.62 | 302 | 19352 | 38861 | 32455011 |
| Genotype drug resistance test positive | 381.86 | 18.62 | 106 | 19548 | 1675 | 32492197 |
| Drug ineffective | 358.65 | 18.62 | 741 | 18913 | 382736 | 32111136 |
| Insomnia | 308.71 | 18.62 | 340 | 19314 | 100008 | 32393864 |
| Hepatitis C virus test positive | 211.36 | 18.62 | 50 | 19604 | 397 | 32493475 |
| Nausea | 195.59 | 18.62 | 526 | 19128 | 320323 | 32173549 |
| Hepatic cirrhosis | 172.05 | 18.62 | 114 | 19540 | 16695 | 32477177 |
| Product dose omission issue | 165.70 | 18.62 | 253 | 19401 | 102322 | 32391550 |
| Ascites | 140.50 | 18.62 | 146 | 19508 | 40045 | 32453827 |
| Viral mutation identified | 124.07 | 18.62 | 52 | 19602 | 2967 | 32490905 |
| Liver transplant | 123.74 | 18.62 | 51 | 19603 | 2789 | 32491083 |
| Hepatitis B reactivation | 98.46 | 18.62 | 46 | 19608 | 3403 | 32490469 |
| Hypotension | 90.35 | 18.62 | 12 | 19642 | 216098 | 32277774 |
| Oesophageal varices haemorrhage | 89.51 | 18.62 | 42 | 19612 | 3137 | 32490735 |
| Dyspepsia | 84.43 | 18.62 | 102 | 19552 | 32953 | 32460919 |
| Hepatic cancer recurrent | 82.66 | 18.62 | 23 | 19631 | 366 | 32493506 |
| Toxicity to various agents | 69.53 | 18.62 | 12 | 19642 | 178029 | 32315843 |
| Hepatic encephalopathy | 62.87 | 18.62 | 60 | 19594 | 14835 | 32479037 |
| Pneumonia | 61.35 | 18.62 | 75 | 19579 | 355177 | 32138695 |
| Febrile neutropenia | 59.85 | 18.62 | 3 | 19651 | 119563 | 32374309 |
| Hepatic cancer | 59.67 | 18.62 | 43 | 19611 | 7197 | 32486675 |
| Off label use | 59.10 | 18.62 | 59 | 19595 | 306261 | 32187611 |
| Abdominal discomfort | 52.33 | 18.62 | 105 | 19549 | 52519 | 32441353 |
| Irritability | 51.72 | 18.62 | 69 | 19585 | 24585 | 32469287 |
| Focal segmental glomerulosclerosis | 51.48 | 18.62 | 25 | 19629 | 2015 | 32491857 |
| General physical health deterioration | 44.46 | 18.62 | 8 | 19646 | 115251 | 32378621 |
| Diarrhoea | 44.17 | 18.62 | 373 | 19281 | 364429 | 32129443 |
| Glomerular filtration rate decreased | 43.74 | 18.62 | 46 | 19608 | 12765 | 32481107 |
| Intentional dose omission | 43.19 | 18.62 | 23 | 19631 | 2251 | 32491621 |
| Hepatic failure | 41.37 | 18.62 | 76 | 19578 | 35604 | 32458268 |
| White blood cell count decreased | 40.70 | 18.62 | 4 | 19650 | 91194 | 32402678 |
| Dyspnoea | 37.81 | 18.62 | 104 | 19550 | 361941 | 32131931 |
| Hepatitis C RNA positive | 36.99 | 18.62 | 11 | 19643 | 224 | 32493648 |
| Malignant neoplasm progression | 33.60 | 18.62 | 4 | 19650 | 78492 | 32415380 |
| Pyrexia | 32.58 | 18.62 | 93 | 19561 | 319875 | 32173997 |
| Influenza like illness | 30.44 | 18.62 | 57 | 19597 | 27083 | 32466789 |
| Complications of transplanted lung | 30.05 | 18.62 | 9 | 19645 | 188 | 32493684 |
| Ectopic kidney | 29.76 | 18.62 | 7 | 19647 | 54 | 32493818 |
| Chronic hepatitis C | 28.59 | 18.62 | 11 | 19643 | 501 | 32493371 |
| Alpha 1 foetoprotein increased | 28.02 | 18.62 | 12 | 19642 | 722 | 32493150 |
| Drug abuse | 28.00 | 18.62 | 7 | 19647 | 80236 | 32413636 |
| Therapy cessation | 27.89 | 18.62 | 41 | 19613 | 15972 | 32477900 |
| Neutropenia | 27.77 | 18.62 | 27 | 19627 | 142148 | 32351724 |
| Disease progression | 27.68 | 18.62 | 9 | 19645 | 86853 | 32407019 |
| Fall | 27.31 | 18.62 | 48 | 19606 | 196153 | 32297719 |
| Myalgia | 27.12 | 18.62 | 109 | 19545 | 81121 | 32412751 |
| Laryngomalacia | 25.27 | 18.62 | 9 | 19645 | 329 | 32493543 |
| Dry mouth | 25.01 | 18.62 | 49 | 19605 | 24070 | 32469802 |
| Drug hypersensitivity | 24.48 | 18.62 | 7 | 19647 | 73393 | 32420479 |
| Constipation | 24.44 | 18.62 | 145 | 19509 | 126228 | 32367644 |
| Hepatic fibrosis | 24.27 | 18.62 | 19 | 19635 | 3599 | 32490273 |
| Cryoglobulinaemia | 23.84 | 18.62 | 9 | 19645 | 389 | 32493483 |
| Migraine | 23.20 | 18.62 | 35 | 19619 | 13950 | 32479922 |
| Abnormal dreams | 22.78 | 18.62 | 27 | 19627 | 8537 | 32485335 |
| Tachycardia | 22.20 | 18.62 | 10 | 19644 | 79078 | 32414794 |
| Cardiac failure | 22.20 | 18.62 | 14 | 19640 | 91659 | 32402213 |
| Plasma cell myeloma | 22.20 | 18.62 | 4 | 19650 | 57610 | 32436262 |
| Pancytopenia | 22.00 | 18.62 | 14 | 19640 | 91221 | 32402651 |
| Hypoxia | 21.48 | 18.62 | 3 | 19651 | 52129 | 32441743 |
| Respiratory failure | 21.33 | 18.62 | 20 | 19634 | 107162 | 32386710 |
| Erythema | 21.09 | 18.62 | 12 | 19642 | 83093 | 32410779 |
| Extra dose administered | 20.97 | 18.62 | 17 | 19637 | 3386 | 32490486 |
| Ammonia increased | 20.79 | 18.62 | 19 | 19635 | 4445 | 32489427 |
| Tinnitus | 20.31 | 18.62 | 37 | 19617 | 17212 | 32476660 |
| Drug interaction | 19.73 | 18.62 | 210 | 19444 | 217975 | 32275897 |
| Deep vein thrombosis | 19.60 | 18.62 | 7 | 19647 | 63706 | 32430166 |
| Virologic failure | 19.38 | 18.62 | 17 | 19637 | 3770 | 32490102 |
| Oxygen saturation decreased | 19.28 | 18.62 | 3 | 19651 | 48096 | 32445776 |
| Product use complaint | 19.02 | 18.62 | 11 | 19643 | 1263 | 32492609 |
| Product use in unapproved indication | 18.90 | 18.62 | 15 | 19639 | 87189 | 32406683 |
| Platelet count decreased | 18.84 | 18.62 | 25 | 19629 | 114566 | 32379306 |
| Blood pressure decreased | 18.72 | 18.62 | 4 | 19650 | 51076 | 32442796 |
| Completed suicide | 18.72 | 18.62 | 17 | 19637 | 92500 | 32401372 |
| Pulmonary embolism | 18.62 | 18.62 | 14 | 19640 | 83645 | 32410227 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AP51 | 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 | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA EPC | N0000191256 | Hepatitis C Virus NS5A Inhibitor |
| CHEBI has role | CHEBI:36044 | anti-virus drug |
| CHEBI has role | CHEBI:64924 | hepatitis C protease inhibitors |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic hepatitis C | indication | 128302006 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 12.48 | acidic |
| pKa2 | 13.1 | acidic |
| pKa3 | 13.41 | acidic |
| pKa4 | 13.92 | acidic |
| pKa5 | 6.07 | Basic |
| pKa6 | 5.39 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 45MG;200MG | HARVONI | GILEAD SCIENCES INC | N205834 | Aug. 28, 2019 | RX | TABLET | ORAL | Nov. 15, 2022 | INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS |
| 90MG;400MG | HARVONI | GILEAD SCIENCES INC | N205834 | Oct. 10, 2014 | RX | TABLET | ORAL | Nov. 15, 2022 | INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS |
| 33.75MG;150MG/PACKET | HARVONI | GILEAD SCIENCES INC | N212477 | Aug. 28, 2019 | RX | PELLETS | ORAL | Nov. 15, 2022 | INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS |
| 45MG;200MG/PACKET | HARVONI | GILEAD SCIENCES INC | N212477 | Aug. 28, 2019 | RX | PELLETS | ORAL | Nov. 15, 2022 | INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS |
| 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 |
| 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 |
| 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 |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 11.40 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 10.51 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Nonstructural protein 5A | Unclassified | EC50 | 10.51 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 013TE6E4WV | UNII |
| D10442 | KEGG_DRUG |
| 4033796 | VUID |
| N0000191095 | NUI |
| 4033796 | VANDF |
| C3851350 | UMLSCUI |
| CHEBI:85089 | CHEBI |
| CHEMBL2374220 | ChEMBL_ID |
| 67505836 | PUBCHEM_CID |
| DB09027 | DRUGBANK_ID |
| C586541 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11271 | IUPHAR_LIGAND_ID |
| 9796 | INN_ID |
| 1591922 | RXNORM |
| 30602 | MMSL |
| d08295 | MMSL |
| 015709 | NDDF |
| 712517005 | SNOMEDCT_US |
| 714387002 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Harvoni | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-1801 | TABLET, FILM COATED | 90 mg | ORAL | NDA | 36 sections |
| Harvoni Access | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-1802 | TABLET, FILM COATED | 90 mg | ORAL | Export only | 31 sections |
| Harvoni | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-1803 | TABLET, FILM COATED | 45 mg | ORAL | NDA | 36 sections |
| Harvoni | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-1804 | PELLET | 45 mg | ORAL | NDA | 36 sections |
| Harvoni | HUMAN PRESCRIPTION DRUG LABEL | 2 | 61958-1805 | PELLET | 33.75 mg | ORAL | NDA | 36 sections |
| Ledipasvir and Sofosbuvir | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72626-2601 | TABLET, FILM COATED | 90 mg | ORAL | NDA AUTHORIZED GENERIC | 35 sections |