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

Stem definitionDrug idCAS RN
4224 53179-13-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pirfenidone
  • esbriet
  • glaspia
pyridone, indicated for the treatment of idiopathic pulmonary fibrosis
  • Molecular weight: 185.23
  • Formula: C12H11NO
  • CLOGP: 2.10
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 20.31
  • ALOGS: -1.81
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2.40 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 16, 2008 PMDA
Feb. 28, 2011 EMA Roche Registration Limited
Oct. 15, 2014 FDA GENENTECH INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 674.47 24.74 542 9766 324837 50269979
Nausea 379.64 24.74 578 9730 704820 49889996
Decreased appetite 313.92 24.74 286 10022 200637 50394179
Dyspepsia 161.35 24.74 128 10180 73969 50520847
Weight decreased 145.79 24.74 201 10107 221044 50373772
Pulmonary function test abnormal 135.98 24.74 35 10273 1276 50593540
Cough 115.68 24.74 189 10119 241075 50353741
Photosensitivity reaction 114.98 24.74 55 10253 12856 50581960
Pulmonary function test decreased 107.11 24.74 36 10272 3352 50591464
Dizziness 105.32 24.74 223 10085 346146 50248670
Oxygen saturation decreased 103.61 24.74 99 10209 73149 50521667
Dyspnoea 101.17 24.74 291 10017 547317 50047499
Forced vital capacity decreased 92.14 24.74 24 10284 917 50593899
Fatigue 90.05 24.74 331 9977 707270 49887546
Abdominal discomfort 81.96 24.74 159 10149 231482 50363334
Lung diffusion test decreased 81.80 24.74 20 10288 589 50594227
Vomiting 72.75 24.74 232 10076 460526 50134290
Diarrhoea 71.89 24.74 272 10036 588204 50006612
Gastric disorder 70.61 24.74 54 10254 29494 50565322
Sunburn 54.71 24.74 20 10288 2383 50592433
Therapy cessation 54.51 24.74 44 10264 25967 50568849
Therapy interrupted 52.97 24.74 39 10269 20113 50574703
Pneumonia 51.12 24.74 181 10127 378220 50216596
Gastrooesophageal reflux disease 45.03 24.74 66 10242 76362 50518454
Amblyopia 43.10 24.74 10 10298 234 50594582
Drug ineffective 43.05 24.74 63 10245 819270 49775546
Malaise 42.30 24.74 157 10151 335375 50259441
Flatulence 38.19 24.74 38 10270 29420 50565396
Dyspnoea exertional 35.75 24.74 48 10260 51185 50543631
No adverse event 34.05 24.74 38 10270 33540 50561276
Insomnia 33.00 24.74 94 10214 174771 50420045
Asthenia 31.94 24.74 139 10169 318903 50275913
Skin reaction 31.78 24.74 23 10285 11545 50583271
Abdominal pain upper 31.39 24.74 87 10221 159222 50435594
Rash 29.90 24.74 171 10137 437300 50157516
Joint swelling 29.30 24.74 7 10301 245279 50349537
Cystitis 28.45 24.74 40 10268 44524 50550292
Eye pruritus 27.95 24.74 22 10286 12512 50582304
Pharyngeal mass 26.88 24.74 7 10301 267 50594549
Upper respiratory tract congestion 26.62 24.74 11 10297 1818 50592998
Acute kidney injury 26.28 24.74 7 10301 228051 50366765
Dairy intolerance 25.43 24.74 5 10303 51 50594765

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 1947.04 23.95 1673 18003 340411 29214440
Decreased appetite 580.01 23.95 590 19086 144752 29410099
Photosensitivity reaction 407.54 23.95 172 19504 9086 29545765
Weight decreased 286.99 23.95 422 19254 150483 29404368
Fatigue 243.43 23.95 601 19075 316220 29238631
Sunburn 235.94 23.95 73 19603 1547 29553304
Pulmonary function test abnormal 229.90 23.95 76 19600 2006 29552845
Nausea 229.76 23.95 556 19120 288699 29266152
Dyspnoea 229.31 23.95 599 19077 326133 29228718
Abdominal discomfort 216.73 23.95 209 19467 47694 29507157
Dyspepsia 216.22 23.95 171 19505 29954 29524897
Pulmonary function test decreased 198.75 23.95 82 19594 4081 29550770
Rash 197.61 23.95 407 19269 189412 29365439
Cough 191.21 23.95 319 19357 126408 29428443
Oxygen saturation decreased 164.67 23.95 175 19501 44762 29510089
Acute kidney injury 105.19 23.95 24 19652 265243 29289608
Dizziness 103.97 23.95 319 19357 189365 29365486
Lung transplant 102.54 23.95 40 19636 1716 29553135
Forced vital capacity decreased 101.38 23.95 31 19645 630 29554221
Gastric disorder 99.50 23.95 71 19605 10633 29544218
Gastrooesophageal reflux disease 93.55 23.95 110 19566 31386 29523465
Therapy interrupted 92.96 23.95 62 19614 8324 29546527
Asthenia 90.43 23.95 331 19345 214919 29339932
Abdominal pain upper 89.63 23.95 152 19524 60841 29494010
Dysgeusia 85.98 23.95 90 19586 22584 29532267
Pruritus 69.99 23.95 203 19473 116646 29438205
Toxicity to various agents 68.16 23.95 16 19660 173645 29381206
Lung diffusion test decreased 67.09 23.95 22 19654 565 29554286
Pyrexia 67.01 23.95 56 19620 287566 29267285
Oesophageal pain 65.38 23.95 23 19653 735 29554116
Pulmonary fibrosis 64.77 23.95 65 19611 15517 29539334
Therapy cessation 61.35 23.95 61 19615 14401 29540450
Heart rate increased 58.43 23.95 98 19578 38840 29516011
Febrile neutropenia 56.28 23.95 5 19671 112235 29442616
Dyspnoea exertional 54.96 23.95 92 19584 36398 29518453
Anorectal discomfort 54.71 23.95 25 19651 1594 29553257
Malaise 54.35 23.95 230 19446 159372 29395479
Eructation 52.72 23.95 33 19643 3973 29550878
Idiopathic pulmonary fibrosis 51.80 23.95 30 19646 3138 29551713
Constipation 51.54 23.95 180 19496 113980 29440871
Pneumonia 51.36 23.95 376 19300 319796 29235055
Chest injury 51.18 23.95 23 19653 1410 29553441
Thrombocytopenia 49.84 23.95 14 19662 134809 29420042
Flatulence 49.51 23.95 60 19616 17649 29537202
Painful respiration 48.92 23.95 21 19655 1153 29553698
Productive cough 48.67 23.95 80 19596 31179 29523672
Completed suicide 48.13 23.95 3 19673 90243 29464608
Neutropenia 48.09 23.95 14 19662 131697 29423154
Sneezing 47.39 23.95 32 19644 4382 29550469
Walking aid user 47.38 23.95 22 19654 1455 29553396
Dry skin 46.63 23.95 67 19609 23240 29531611
Muscle strain 46.24 23.95 29 19647 3504 29551347
Anaemia 45.65 23.95 40 19636 200911 29353940
Pulmonary pain 44.18 23.95 15 19661 430 29554421
Oxygen consumption increased 43.88 23.95 20 19656 1267 29553584
Lung disorder 43.66 23.95 75 19601 30287 29524564
Pancytopenia 43.66 23.95 3 19673 83165 29471686
Gastrointestinal motility disorder 42.11 23.95 23 19653 2149 29552702
Gastrointestinal disorder 41.40 23.95 71 19605 28635 29526216
Diarrhoea 39.95 23.95 366 19310 332332 29222519
Food aversion 39.60 23.95 13 19663 335 29554516
Feeling cold 39.40 23.95 39 19637 9152 29545699
Overdose 38.82 23.95 4 19672 79815 29475036
Haemoglobin decreased 38.68 23.95 12 19664 108363 29446488
Ageusia 38.46 23.95 38 19638 8900 29545951
Appetite disorder 37.58 23.95 21 19655 2051 29552800
No adverse event 37.56 23.95 52 19624 17426 29537425
Platelet count decreased 36.62 23.95 12 19664 104660 29450191
International normalised ratio decreased 34.86 23.95 26 19650 4164 29550687
Confusional state 34.80 23.95 21 19655 127856 29426995
Hot flush 33.09 23.95 45 19631 14825 29540026
Hypersomnia 32.63 23.95 38 19638 10716 29544135
Jaw cyst 32.41 23.95 6 19670 9 29554842
Nasopharyngitis 32.18 23.95 100 19576 59565 29495286
Hypotension 31.96 23.95 50 19626 194304 29360547
Blood creatinine increased 31.12 23.95 9 19667 85093 29469758
Septic shock 30.77 23.95 3 19673 62557 29492294
Rhinorrhoea 30.73 23.95 53 19623 21466 29533385
White blood cell count decreased 30.15 23.95 9 19667 83353 29471498
Skin exfoliation 30.04 23.95 54 19622 22591 29532260
Aortic aneurysm 29.69 23.95 28 19648 6192 29548659
Ill-defined disorder 28.54 23.95 37 19639 11641 29543210
Exercise tolerance decreased 26.06 23.95 22 19654 4209 29550642
Seizure 25.74 23.95 15 19661 93108 29461743
Respiratory failure 25.60 23.95 130 19546 97001 29457850
Lung neoplasm malignant 25.44 23.95 39 19637 14318 29540533
Irregular breathing 24.87 23.95 7 19669 105 29554746
Intentional product use issue 24.57 23.95 73 19603 42425 29512426
Tachycardia 24.12 23.95 9 19667 72401 29482450
Product use in unapproved indication 24.00 23.95 14 19662 86861 29467990

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 1411.22 23.35 1225 21039 481480 63994988
Decreased appetite 740.49 23.35 676 21588 280613 64195855
Photosensitivity reaction 355.32 23.35 157 22107 18016 64458452
Pulmonary function test abnormal 343.99 23.35 98 22166 3066 64473402
Nausea 342.92 23.35 800 21464 785000 63691468
Weight decreased 328.35 23.35 446 21818 285293 64191175
Dyspepsia 300.27 23.35 237 22027 80075 64396393
Pulmonary function test decreased 278.95 23.35 99 22165 6362 64470106
Dyspnoea 265.26 23.35 687 21577 717987 63758481
Fatigue 260.37 23.35 700 21564 748030 63728438
Oxygen saturation decreased 242.94 23.35 238 22026 106938 64369530
Cough 218.64 23.35 381 21883 301767 64174701
Abdominal discomfort 168.38 23.35 257 22007 182065 64294403
Sunburn 166.70 23.35 57 22207 3275 64473193
Dizziness 165.81 23.35 419 21845 429744 64046724
Forced vital capacity decreased 156.01 23.35 45 22219 1471 64474997
Lung diffusion test decreased 138.83 23.35 39 22225 1157 64475311
Asthenia 124.13 23.35 376 21888 427668 64048800
Gastric disorder 119.47 23.35 91 22173 29106 64447362
Rash 115.76 23.35 384 21880 458165 64018303
Dyspnoea exertional 104.45 23.35 128 22136 73602 64402866
Gastrooesophageal reflux disease 101.44 23.35 134 22130 83009 64393459
Pneumonia 95.11 23.35 413 21851 559163 63917305
Acute kidney injury 94.52 23.35 20 22244 449220 64027248
Flatulence 91.66 23.35 85 22179 35581 64440887
Lung transplant 81.88 23.35 36 22228 4072 64472396
Therapy cessation 78.83 23.35 75 22189 32414 64444054
Dysgeusia 78.76 23.35 89 22175 46958 64429510
Toxicity to various agents 76.80 23.35 16 22248 363497 64112971
Abdominal pain upper 70.76 23.35 174 22090 174856 64301612
Malaise 62.99 23.35 287 21977 395960 64080508
Eructation 62.05 23.35 39 22225 9152 64467316
Walking aid user 61.78 23.35 34 22230 6247 64470221
Diarrhoea 61.71 23.35 443 21821 722261 63754207
Constipation 59.35 23.35 194 22070 229143 64247325
Oesophageal pain 56.76 23.35 26 22238 3237 64473231
Anorectal discomfort 56.58 23.35 25 22239 2860 64473608
Idiopathic pulmonary fibrosis 55.99 23.35 27 22237 3773 64472695
Pyrexia 54.31 23.35 68 22196 558576 63917892
Chest injury 53.98 23.35 23 22241 2410 64474058
Febrile neutropenia 52.65 23.35 3 22261 187654 64288814
Pulmonary fibrosis 50.81 23.35 57 22207 29821 64446647
Therapy interrupted 50.02 23.35 47 22217 19989 64456479
Ageusia 49.87 23.35 40 22224 13773 64462695
Painful respiration 45.72 23.35 22 22242 3059 64473409
Heart rate increased 45.15 23.35 103 22161 98572 64377896
Dry skin 44.13 23.35 70 22194 51091 64425377
Drug ineffective 42.92 23.35 148 22116 840099 63636369
Off label use 42.21 23.35 98 22166 632708 63843760
Thrombocytopenia 41.18 23.35 13 22251 223788 64252680
Aortic aneurysm 41.02 23.35 28 22236 7546 64468922
Product use in unapproved indication 38.88 23.35 7 22257 176611 64299857
Amblyopia 38.70 23.35 10 22254 214 64476254
Solar dermatitis 38.23 23.35 10 22254 225 64476243
Product use issue 38.13 23.35 4 22260 151711 64324757
Pancytopenia 38.11 23.35 3 22261 143306 64333162
Gastrointestinal motility disorder 37.55 23.35 23 22241 5156 64471312
Productive cough 37.53 23.35 80 22184 73123 64403345
Skin reaction 36.78 23.35 32 22232 12320 64464148
Muscle strain 36.76 23.35 27 22237 8167 64468301
Sneezing 36.59 23.35 35 22229 15216 64461252
Pruritus 36.05 23.35 207 22057 312193 64164275
Neutropenia 35.86 23.35 19 22245 239605 64236863
Overdose 35.83 23.35 6 22258 159560 64316908
Food aversion 35.14 23.35 12 22252 686 64475782
Respiratory failure 34.40 23.35 128 22136 161055 64315413
International normalised ratio decreased 34.36 23.35 25 22239 7453 64469015
Insomnia 34.13 23.35 147 22117 197689 64278779
Skin exfoliation 34.10 23.35 58 22206 44827 64431641
Haemoptysis 32.89 23.35 60 22204 48988 64427480
Lung disorder 31.88 23.35 67 22197 60633 64415835
Anaemia 31.86 23.35 51 22213 378629 64097839
Feeling cold 31.72 23.35 40 22224 23638 64452830
Pain 31.32 23.35 93 22171 553418 63923050
Hypokalaemia 31.19 23.35 3 22261 121900 64354568
Platelet count decreased 30.38 23.35 10 22254 167701 64308767
Oxygen consumption increased 29.83 23.35 19 22245 4562 64471906
Exercise tolerance decreased 29.27 23.35 23 22241 7687 64468781
Vomiting 29.03 23.35 304 21960 550813 63925655
Haemochromatosis 28.12 23.35 12 22252 1262 64475206
Condition aggravated 27.84 23.35 54 22210 372372 64104096
Hot flush 27.81 23.35 54 22210 46181 64430287
Hypersomnia 27.51 23.35 34 22230 19683 64456785
Hospitalisation 27.46 23.35 72 22192 75135 64401333
Confusional state 27.22 23.35 30 22234 261114 64215354
Treatment failure 27.11 23.35 4 22260 116812 64359656
Haemoglobin decreased 26.99 23.35 17 22247 195046 64281422
Joint swelling 26.86 23.35 21 22243 215361 64261107
Septic shock 25.93 23.35 3 22261 105434 64371034
White blood cell count decreased 25.93 23.35 11 22253 157826 64318642
Seizure 25.30 23.35 13 22251 166879 64309589
Lung neoplasm malignant 25.25 23.35 34 22230 21414 64455054
Pneumothorax 24.85 23.35 36 22228 24262 64452206
Pulmonary hypertension 24.28 23.35 49 22215 43090 64433378
Tachycardia 23.66 23.35 11 22253 149568 64326900
Alopecia 23.53 23.35 14 22250 165676 64310792

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AX05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Other immunosuppressants
FDA CS M0018236 Pyridones
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018501 Antirheumatic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA EPC N0000191420 Pyridone
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Idiopathic pulmonary fibrosis indication 700250006 DOID:0050156




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7767225 Sept. 22, 2026 METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7988994 Sept. 22, 2026 METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8753679 Sept. 22, 2026 METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7696236 Dec. 18, 2027 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7767700 Dec. 18, 2027 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8420674 Dec. 18, 2027 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7767700 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8420674 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7767700 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8420674 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7767700 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8420674 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7635707 April 22, 2029 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8592462 April 22, 2029 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8609701 April 22, 2029 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE THEN FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7816383 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7910610 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG INHIBITOR OF CYP1A2
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8013002 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8084475 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8318780 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8648098 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8754109 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8754109 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7816383 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7816383 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7910610 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7910610 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8013002 Jan. 8, 2030 ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8013002 Jan. 8, 2030 MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8084475 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8084475 Jan. 8, 2030 DISCONTINUING A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8318780 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8318780 Jan. 8, 2030 DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8754109 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8754109 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8778947 Aug. 30, 2033 DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH CIPROFLOXACIN
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8778947 Aug. 30, 2033 ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8778947 Aug. 30, 2033 DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4033815 VUID
N0000191097 NUI
D01583 KEGG_DRUG
4033815 VANDF
C0298067 UMLSCUI
CHEBI:32016 CHEBI
CHEMBL1256391 ChEMBL_ID
DB04951 DRUGBANK_ID
C093844 MESH_SUPPLEMENTAL_RECORD_UI
7532 IUPHAR_LIGAND_ID
3825 INN_ID
D7NLD2JX7U UNII
40632 PUBCHEM_CID
1592254 RXNORM
198886 MMSL
29209 MMSL
d08031 MMSL
014994 NDDF
438240001 SNOMEDCT_US
439581000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0480-3610 TABLET, FILM COATED 267 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0480-3611 TABLET, FILM COATED 801 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-8085 TABLET, FILM COATED 267 mg ORAL ANDA 28 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-8086 TABLET, FILM COATED 801 mg ORAL ANDA 28 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 16729-467 TABLET, FILM COATED 267 mg ORAL ANDA 27 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 16729-468 TABLET, FILM COATED 801 mg ORAL ANDA 27 sections
ESBRIET HUMAN PRESCRIPTION DRUG LABEL 1 50242-121 CAPSULE 267 mg ORAL NDA 28 sections
ESBRIET HUMAN PRESCRIPTION DRUG LABEL 1 50242-122 TABLET, COATED 267 mg ORAL NDA 28 sections
ESBRIET HUMAN PRESCRIPTION DRUG LABEL 1 50242-123 TABLET, COATED 801 mg ORAL NDA 28 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 60219-1640 TABLET, FILM COATED 267 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 60219-1641 TABLET, FILM COATED 801 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 60219-1642 CAPSULE 267 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 60219-1642 CAPSULE 267 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 62332-479 TABLET, COATED 267 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 62332-480 TABLET, COATED 801 mg ORAL ANDA 27 sections
Esbriet HUMAN PRESCRIPTION DRUG LABEL 1 64116-121 CAPSULE 267 mg ORAL NDA 26 sections
PIRFENIDONE Human Prescription Drug Label 1 69539-119 TABLET, FILM COATED 267 mg ORAL ANDA 26 sections
PIRFENIDONE Human Prescription Drug Label 1 69539-120 TABLET, FILM COATED 801 mg ORAL ANDA 26 sections
PIRFENIDONE Human Prescription Drug Label 1 72205-181 TABLET, FILM COATED 267 mg ORAL ANDA 26 sections
PIRFENIDONE Human Prescription Drug Label 1 72205-182 TABLET, FILM COATED 801 mg ORAL ANDA 26 sections