pirfenidone Oral Capsule

Brand(s)
Esbriet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-09-30)
Oldest Current Product
2014-10-16
License(s)
NDA
RxNORM
ORAL CAPSULE\PIRFENIDONE
FDAOB
ORAL\CAPSULE\PIRFENIDONE
SPL Active
ORAL\CAPSULE\PIRFENIDONE
SPL Moiety
ORAL\CAPSULE\PIRFENIDONE

product(s) by strength(s)

pirfenidone 267 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420121EsbrietNDAGenentech, Inc.2014-10-16PIRFENIDONEORALCAPSULENDA0225352e8c3537-36d7-4de5-9b5c-7a624b9a9e6e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022535ESBRIETGENENTECH INC2014-10-15p7566729, DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
p8084475, METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER
p8013002, METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
p8609701, CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF PIRFENIDONE
p7767225, METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION, SUBSTANCE
p7767700, DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
p8648098, METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
p7816383, METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
p8754109, METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
p7696236, DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
p7635707, CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
p7910610, METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG INHIBITOR OF CYP1A2
p8778947, DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH CIPROFLOXACIN
p8420674, DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION, SUBSTANCE
p8383150, METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF PIRFENIDONE TO TREAT A FIBROTIC CONDITION, SUBSTANCE
p8753679, METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION, SUBSTANCE
p8592462, CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
p7988994, METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION, SUBSTANCE
p8318780, 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
ORPHAN DRUG EXCLUSIVITY [2021-10-15]
NEW CHEMICAL ENTITY [2019-10-16]
NDA022535_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022535_001RXPIRFENIDONE (267MG)ORALCAPSULETrue2014-10-15ESBRIET

patent(s)

#idexpiration dateapplication(s)
1p7566729 (view patent)2029-04-22NDA022535
2p7635707 (view patent)2029-04-22NDA022535
3p7696236 (view patent)2027-12-18NDA022535
4p7767225 (view patent)2026-09-22NDA022535
5p7767700 (view patent)2027-12-18NDA022535
6p7816383 (view patent)2030-01-08NDA022535
7p7910610 (view patent)2030-01-08NDA022535
8p7988994 (view patent)2026-09-22NDA022535
9p8013002 (view patent)2030-01-08NDA022535
10p8084475 (view patent)2030-01-08NDA022535
11p8318780 (view patent)2030-01-08NDA022535
12p8383150 (view patent)2026-09-22NDA022535
13p8420674 (view patent)2027-12-18NDA022535
14p8592462 (view patent)2029-04-22NDA022535
15p8609701 (view patent)2029-04-22NDA022535
16p8648098 (view patent)2030-01-08NDA022535
17p8753679 (view patent)2026-09-22NDA022535
18p8754109 (view patent)2030-01-08NDA022535
19p8778947 (view patent)2033-08-30NDA022535

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
10ab861c2-d5ca-4f92-854c-6477971a1b38 (view SPL)These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET (pirfenidone) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionIntermune, Inc.2014-10-281641160121
22e8c3537-36d7-4de5-9b5c-7a624b9a9e6e (view SPL)These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET (pirfenidone) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionGenentech, Inc.2015-09-301502420121

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII