nintedanib Oral Capsule

Brand(s)
Ofev
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2014-10-23)
Oldest Current Product
2014-10-28
License(s)
NDA
RxNORM
ORAL CAPSULE\NINTEDANIB
FDAOB
ORAL\CAPSULE\NINTEDANIB ESYLATE
SPL Active
ORAL\CAPSULE\NINTEDANIB
SPL Moiety
ORAL\CAPSULE\NINTEDANIB

product(s) by strength(s)

nintedanib 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970143OfevNDABoehringer Ingelheim Pharmaceuticals, Inc.2014-10-28NINTEDANIBORALCAPSULENDA205832da1c9f37-779e-4682-816f-93d0faa4cfc9

nintedanib 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970145OfevNDABoehringer Ingelheim Pharmaceuticals, Inc.2014-10-28NINTEDANIBORALCAPSULENDA205832da1c9f37-779e-4682-816f-93d0faa4cfc9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205832OFEVBOEHRINGER INGELHEIM PHARMACEUTICALS INC2014-10-15p6762180, SUBSTANCE
p7989474, TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF)
p7119093, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2021-10-15]
NEW CHEMICAL ENTITY [2019-10-15]
NDA205832_001, NDA205832_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205832_001RXNINTEDANIB ESYLATE (EQ 100MG BASE)ORALCAPSULEFalse2014-10-15OFEV
2NDA205832_002RXNINTEDANIB ESYLATE (EQ 150MG BASE)ORALCAPSULETrue2014-10-15OFEV

patent(s)

#idexpiration dateapplication(s)
1p6762180 (view patent)2020-12-10NDA205832
2p7119093 (view patent)2024-02-21NDA205832
3p7989474 (view patent)2024-04-06NDA205832

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1da1c9f37-779e-4682-816f-93d0faa4cfc9 (view SPL)These highlights do not include all the information needed to use OFEV safely and effectively. See full prescribing information for OFEV. OFEV (nintedanib) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-10-232005970143, 005970145

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